cyrilzakka/clinical-trials huggingface dataset:
Outcome Predictors of a Cognitive Intervention in aMCI

Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.

Previous studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.

The investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).

For comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)
* No evidence for other psychiatric axis I disorders according to DSM-IV criteria.
* No evidence for neurological disorders (e.g. stroke)
* No uncontrolled arterial hypertension or diabetes mellitus
* No history of drug / alcohol abuse
* The patient is able to provide written informed consent to participate in the study.
* for the cognitive-reserve-study patients, a high (low) cognitive reserve is defined as a verbal IQ score of \>/= 120 (\</= 110) as assessed by the MWT-B, a German multiple vocabulary test

Exclusion Criteria:

* Evidence for acute psychiatric or neurological disorders
* Uncontrolled arterial hypertension or diabetes mellitus
* History of drug / alcohol abuse
* No ability to participate and no willing to give informed consent and comply with the study restrictions.
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial

Patient grouping

* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).

  6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.

A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.

Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.

Patient grouping

* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol

Group 1 and 2 patients were treated by non-surgical approach in following steps:

1. Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
2. Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
3. Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
4. For each patient, follow up visits every 2 weeks were done to ensure plaque control.
5. Patients were re- examined after 2 weeks (baseline), 3 and 6 months

Eligibility Criteria:
Inclusion Criteria:

* Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included

Exclusion Criteria:

* Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen
Characterization of the Role of Histamine in Children With Asthma

Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.

Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.

The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.


Eligibility Criteria:
Inclusion Criteria:

* children age 7-17 years old
* with the diagnosis of allergic asthma or non-allergic asthma (n=102

Exclusion Criteria:

* history of immunodeficiency, mastocytosis
* chronic abnormal conditions of the skin, liver or kidney
* neoplastic disease
* movement or neurologic disorders
* active eczema on the forearms at the time of study
* history of a previous anaphylactic episode
* evidence of pregnancy (by urinary hCG) or lactation at the time of the study
Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer.

OBJECTIVES: I. Evaluate the reduction in toxicities by combining amifostine with cisplatin, etoposide, and radiotherapy in patients with limited stage small cell lung cancer. II. Evaluate the response rate to this combination by these patients. III. Evaluate the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cisplatin IV on day 1 and etoposide IV daily on days 1-3. This course is repeated every 3 weeks for a total for 4 courses. Patients also receive concurrent radiotherapy 5 days per week for 5.5 weeks starting with the first course of chemotherapy. Patients receive amifostine IV over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3. Patients are followed at 6 and 12 weeks, then every 3 months for 9 months, every 6 months for 1 year, and then until death.

PROJECTED ACCRUAL: There will be 20 patients accrued into this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Primary tumor must be evaluable radiographically

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2 times normal Renal: Creatinine less than 1.5 mg/dL Other: No concurrent active infection No prior malignancy except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Efficacy of a New Topical Anesthetic

A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn).

The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).


Eligibility Criteria:
Inclusion Criteria:

* Previously healthy children of whom venipuncture is needed to be performed.

Exclusion Criteria:

* History of allergic reaction to any local anesthetic.
* History of chronic disease
* Patient's condition requires urgent treatment (e.g. severe dehydration, shock)
* Active local skin infection or skin pathologic condition at the antecubital fossa
* Tattoo, surgical scar or skin condition that might interfere with skin sight assessment.
* Patient undergone venipuncture at the antecubital fossa within the pror two weeks.
* Uncooperative or exceptionally anxious patient.
European Multicentric Study on Parathyroid Carcinoma

The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category.

Parathyroid cancer (PC) is one of the rarest malignancies (0.005% of all tumours) and it represents less than 1% of all the causes of primary hyperparathyroidism (pHPT).

It is frequently a sporadic disease, but it can be part of hereditary syndromes (i.e. HPT- JT, MEN, MEN2A and FIHP).

Clinical and biochemical presentation is usually more severe comparing to other forms of primary hyperparathyroidism as it is often associated to very high serum-calcium and PTH levels and target organs' damages.

Malignancy should be suspected on the basis of the aforementioned biochemical data and the imaging evidences (such as parathyroid lesion dimension \>3 cm, faded edges, inhomogeneous internal features and cervical lymph nodes enlargement).

In case of suspected PC a radical treatment should be proposed to the patient, consisting of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and ipsilateral central neck dissection. Indeed, the oncological radicality during surgical treatment is mandatory, as effective adjuvant therapy is not available.

However, pre-operative differential diagnosis with parathyroid adenoma is still challenging, thus malignancy can be detected only after the histological analysis of the specimen and sometimes after recurrences.

Moreover, parathyroid atypical adenoma entity is still controversial, as it presents suspicious histological features, but certain signs of malignancy are lacking (such as capsular, vessels and neural invasion). Furthermore, natural history and biological behaviour are still unknown.

Eligibility Criteria:
Inclusion Criteria: All adult (18 years old and older) patients that underwent surgery for primary hyperparathyroidism with a final histology of parathyroid carcinoma from 2015 till 2021.

Inclusion Criteria:

* All adult (18 years old and older) patients
* underwent surgery
* final histology of parathyroid carcinoma
* among European centers that participate in the Eurocrine® database between 2015 and 2021

Exclusion Criteria:

• Patients \<18 years old
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis

A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy

A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy 12 subjects with pediatric MS

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 5 Years to 17 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No Criteria
* Subject is between 5 and 17 years of age, inclusive
* Clinically diagnosed Pediatric MS
* Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
* Expanded Disability Status Scale (EDSS) \<= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
* Laboratory values within the following limits:

  * Creatinine 1 . 5 x high normal
  * Hemoglobin

Exclusion Criteria:

* Subjects currently prescribed Campath or Lemtrada
Nutrition, Vision, and Cognition in Sport Study: Beef

The purpose of this study is to determine whether a 30 day beef intervention can improve peak cognitive performance in young, normally menstruating adult women. The control group will consume a daily portion of macronutrient equivalent vegetable source of protein.

The purpose of the Nutrition, Vision, and Cognition in Health Sport: Beef (IONSport-Beef) study is to conduct a randomized controlled trial to evaluate beef as a nutritional intervention to optimize visual cognitive training performance in generally healthy, normally menstruating women. Female subjects of reproductive age (18-40) will be randomly placed in one of two dietary treatment groups: one serving of beef per day for 30 days or a non-meat protein replacement control. Cognitive performance will be measured in 15 training sessions over 10 days using the sophisticated NeuroTracker™ CORE (NT) 3-Dimensional (3D) software program. It is hypothesized that women consuming 1 serving of beef per day for 30 days will have the highest plasma levels of the beef rich nutrients and demonstrate the highest visual cognitive performance and improvement as compared to the no beef control.

Eligibility Criteria:
Inclusion Criteria:

1. 18-40 year old female
2. Eumenorrheic

Exclusion Criteria:

1. Neuroactive medications such as Ritalin, Adderall, antidepressants etc
2. Dietary supplements
3. Iron intake above 15mg/day
4. Protein intake above 1.5 g/kg/day
5. More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months
6. History of affective disorder
7. Visual impairments uncorrected by glasses
8. Amenorrhea or dysmenorrhea
9. Currently being treated for anemia
10. \>3 servings of beef per week
11. \<20 BMI or BMI \>35
12. Consume \>100mg caffeine/day (\>1 cup of coffee or soda)
13. \<1 hour/week physical activity, \>4 hours/week vigorous activity
14. Depression score \>18 (Beck Depression Inventory)
15. \<20 Kcal/kg/day
A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors

Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors.

Content from an existing text-messaging survivorship education intervention will be adapted to a novel text-messaging platform, Chorus. Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. In-depth interviews will be conducted with each participant during the study, and a focus group with all participants will be conducted at the end of the study. Qualitative analysis will determine areas for improvement in the text messaging intervention in order to ensure acceptability and feasibility in AYA survivors. The text messaging intervention on Chorus will be adapted to better suit the needs of AYA survivors based on the results of the qualitative analysis. Mobile phone interventions offer a cost-effective, age-appropriate approach to AYA survivorship care education. If effective, the text-messaging intervention will be evaluated in a randomized, controlled pilot trial to improve rates of survivorship care and clinical outcomes for AYA survivors.

Aim 1: To adapt and enhance an existing text messaging intervention to an expanded two-way multi-media mobile phone messaging platform (Chorus) that will improve knowledge regarding the risk of late effects among AYA survivors, intent to seek recommended survivorship care, and completion of standard survivorship care goals. a. both two-way text messaging to improve Children?s Oncology Group (COG) survivorship guideline adherence b. web-based educational content for survivors of key survivorship messages regarding risk for late effects and need for ongoing survivorship care c. Monthly peer navigation phone calls to address barriers and promote retention d. utilization of pre and post-test questionnaires for participants to access and complete within the Chorus platform Aim 2: To test the acceptability and feasibility of the expanded mobile phone intervention content to improve messaging and strategies for survivorship care using qualitative methodologies and applying the Technology Acceptance Model (TAM) within a sample of AYA survivors. a. perceived usefulness of the text messaging system b. perceived ease of use of the text messaging system c. effect of the text messaging system on health-related behavior intent

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between the ages of 18 to 39 years at the time of enrollment
* Patient must reside in the greater Los Angeles area.
* Patients must have received survivorship care at the University of California at Los Angeles (UCLA)
* Patients must be fluent in English.
* Patients must be off cancer therapy for at least one year.
* Patients must have personal access to a smart phone with text messaging and internet and/or data capability.

Exclusion Criteria:

-
Pedal@Work: A Worksite Wellness Program

The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.

Recent research indicates prolonged sedentary behaviors such as computer use and workplace sitting are particularly damaging resulting in increased risk for chronic diseases such as cardiovascular disease, type 2 diabetes and obesity. Few interventions have been tested with the specific purpose of reducing sedentary time to improve risk factors for cardiometabolic diseases. The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention. Participants will be followed for 12 weeks and randomized to either a treatment or wait list control group which will have the option to crossover into the intervention after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 21 and 65 years
* Sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week)
* Working full time (35+ hours/week) at a sedentary desk dependant occupation
* Overweight (Body Mass Index \> 25.0 kg/m2 but less than 40.0 kg/2)
* Apparently healthy as assessed by a health history screening survey
* Devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases
* Free from exercise/physical activity limitations

Exclusion Criteria:

* Adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. Note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation.
* Being unable to exercise