cyrilzakka/clinical-trials huggingface dataset:
Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

This study investigates the clinical and biochemical results of vitamin D supplementation in addition to non-surgical periodontal treatment in individuals with Type II diabetes mellitus and periodontitis.

38 individuals with T2DM and periodontitis were included into the study. Clinical periodontal measurements including probing depth, clinical attachment level, plaque and gingival indices were recorded The individuals included in the study were divided into two groups: Individuals given D3K2 with periodontal therapy were included in the test group, and individuals given placebo with periodontal therapy were included in the control group. All serum and gingival crevicular fluid samples from individuals who underwent non-surgical periodontal treatment were taken again at 3rd and 6th months, and clinical periodontal measurements were recorded. Glycated hemoglobin A1c (HbA1c), fasting blood glucose (FBG), 25(OH)D3, parathyroid hormone (PTH), calcium (Ca) and magnesium (Mg) values were determined in serum samples. GCF and serum IL-1ß and IL-10 values were analyzed by enzyme-linked immunosorbent analysis (ELISA).

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with Stage I-II periodontitis
2. Individuals with HbA1c value ≥6.5 and diagnosed with type 2 DM according to ADA at least 1 year before the study
3. Individuals who do not have a systemic disease other than DM
4. Individuals who do not have systemic complications of diabetes
5. Individuals with 25(OH)D3 value between 20 ng/mL and 30 ng/mL
6. Individuals who are under the control of a doctor for their diabetes
7. Individuals who have not used any antibiotics or long-term anti-inflammatory drugs in the last 6 months
8. Individuals who have not received periodontal treatment in the last 6 months
9. Individuals with BMI value of 18.5 to 30 kg/m2

Exclusion Criteria:

1. Smokers
2. Individuals who use alcohol
3. Pregnant or lactating individuals
4. Individuals taking any antioxidant or vitamin supplements
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning.

All included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints. Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.

This study will combine MR imaging techniques together with elaborate neuropsychological assessments and RT dosimetry in 120 patients who will be examined baseline (before RT) and followed longitudinally after RT.

The first objective is to build an NTCP model for neurocognitive decline after RT (for each cognitive domain separately), linking dose-volume parameters to structures within the brain susceptible to neurological damage and neurocognitive decline after radiotherapy. These NTCP models can be used to make predictions on neurocognitive decline in future primary brain tumour patients receiving cranial RT.

The second objective is to evaluate dose-dependent neurocognitive decline. In particular, the investigators will assess:

* Prevalence and severity of neurocognitive decline after RT for all cognitive domains
* Brain structures or functional brain connections important in neurocognitive functioning (based on dedicated MRI).
* Dose-dependencies of specific neurocognitive skills after RT in adult brain tumour patients
* Correlations between RT dosimetry and early brain changes (MRI)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base of skull tumour, who are amenable for conventionally fractionated radiotherapy (photon or proton irradiation)

Exclusion Criteria:

* Patients with tumours with poor prognostic characteristics:

  * Incompletely resected IDH-wild-type glioma
  * Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma
  * grade III meningioma
  * H3K27M+ midline glioma
* Patients with tumours requiring craniospinal irradiation (CSI)/whole ventricular irradiation (WVI)
* Hypofractionated/stereotactic radiation (fraction sizes \> 2 Gy per fraction)
* Inability to perform the cognitive tests or self-report inventories because of motor/sensory deficits or insufficient Dutch language proficiency
* Mental retardation documented before diagnosis
* Pre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism/learning disorders)
* Relapse previously treated by chemo and/or radiation therapy
* Genetic syndrome (e.g. Down)
* Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker/ICD/neurostimulator)
Enhancing Smoking Cessation Via Telehealth Options in Primary Care

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
2. age 18+
3. enrolled in MyChart or willing to enroll
4. possess a valid e-mail address that is checked daily
5. owner of an iOS or Android smartphone to provide remote CO
6. have a valid mailing address
7. English fluency

Exclusion Criteria:

1) Use of an FDA-approved cessation medication in the last 7 days
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults

The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.

Secondary Objectives:

Immunogenicity

To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.

To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

Safety:

To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.

To describe the safety profile after vaccination.

Comfort of the vaccination assessment:

To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.


Eligibility Criteria:
Inclusion Criteria :

* Aged 18 to 60 years on the day of inclusion.
* Informed consent form signed.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a woman, inability to bear a child or negative urine pregnancy test at the first visit.

Exclusion Criteria :

* Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Febrile illness (oral temperature \>= 37.5°C, or rectal equivalent temperature \>= 38.0°C) on the day of inclusion.
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Blood or blood-derived products received in the past 3 months.
* Any vaccination in the 4 weeks preceding the trial vaccination.
* Vaccination planned in the 4 weeks following the trial vaccination.
* Previous vaccination against influenza (in the previous 6 months).
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.

OBJECTIVES:

* To identify microRNAs that behave as oncogenes or as tumor suppressor genes in B-lineage acute lymphoblastic leukemia (ALL) in vitro and in vivo.
* To examine if single microRNA or signatures of microRNA correspond to different clinical outcomes in cytogenetically distinct B-ALL groups.

OUTLINE: RNA from archived samples are analyzed for microRNA expression profile in vitro and in vivo.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Samples from patients enrolled on ECOG-2993
* Samples from patients with recurrent cytogenetic abnormalities other than BCR-ABL, including MLL/AF4, E2A/PBX1, and TEL/AML1

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Sensory Nerve Function and Exercise Therapy Response in Chronic Low Back Pain

This observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. Measures collected include sural sensory nerve conduction, quantitative sensory testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is hypothesized that baseline sensory nerve dysfunction may be associated with reduced response to exercise therapy in chronic low back pain.

While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient responses are variable. Differences in baseline sensory nerve function could plausibly contribute to exercise therapy outcomes. This cross-sectional quantitative observational study will investigate if baseline sensory nerve conduction amplitudes and quantitative sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized as responders or non-responders to a 12-week standardized exercise regime. A sample of 50 NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention sensory nerve conduction and QST measures. It is hypothesized that exercise therapy responders will show greater improvements in sensory thresholds correlating with pain relief. Results aim to elucidate neural factors associated with long-term exercise therapy outcomes in chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 20-60 years
* Nonspecific chronic low back pain \>3 months
* Baseline pain ≥6/10 and disability ≥40%

Exclusion Criteria:

* Radicular leg pain
* Prior lumbar surgery
* Serious spinal pathology
Exercise Training in Asthma

The aim of the study is to compare two methods of exercise training: alternate load versus constant load realized at moderate or high intensities, in order to define the interests and the limits of each one of these two methods. The finality is to make possible to the expert to choose what exercise training induces the best results quickly and to make its choice according to the therapeutic objectives which it lays down.We also evaluate the effects of these exercises training on the vagal response and the bronchial tone of the asthmatics. From a clinical point of view, a close attention will be paid to the effects of these exercises training on the control of asthma and the quality of life of the subjects


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old
* mild to moderate persistent asthma (GINA classification)
* stabilized asthma
* physical activity level between 5 and 11 (Baecke and coll, 1982)
* no contra-indication for physical training

Exclusion Criteria:

* cardiovascular pathology
* metabolic pathology
* traumatic pathology
* BMI≥30
* tobacco
* diabetes
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients

This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with IgA nephropathy confirmed by renal biopsy
* Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD: Modification of Diet in Renal Disorder)
* UACR level between 0.3 and 3.0
* Blood pressure measurements \< 130/80mmHg

Exclusion Criteria:

* Use of immunosuppressants for more than two weeks within last one month
* Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue \& additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker
* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
* Hypersensitivity to the investigational drug or macrolide agents
* Use of potassium-sparing diuretics
* Persistence of liver function abnormality more than 1 month or presence of acute active hepatitis
* Other investigational drug within last 30 days
Effects of Wearing a Face Mask During CrossFit Exercise

Face masks are important for prevention of transmission and contracting viruses such as COVID-19. Gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. This study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during Crossfit exercise training.

Face masks are important for prevention of transmission and contracting viruses such as COVID-19. Gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. This study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during Crossfit exercise training. Twenty-four men and women will be randomly assigned to perform exercise during Crossfit exercise while wearing or not wearing a surgical face mask in a cross-over study. Two types of exercise sessions will be assessed: A high intensity interval session and a continuous exercise session. There will therefore be four exercise sessions evaluated in our randomized cross-over design: 1) high intensity exercise while wearing a face mask; 2) high intensity exercise with no face mask; 3) continuous exercise while wearing a face mask; 4) continuous exercise with no face mask. Outcome variables to be assessed include exercise performance during the sessions (total repetitions for pull-ups, push-ups, and squats during continuous exercise and total repetitions for box jumps during high-intensity exercise). Heart rate, rating of perceived exertion, and dyspnea will also be assessed throughout the exercise sessions.

Eligibility Criteria:
Inclusion Criteria:

* Experienced with CrossFit exercise training

Exclusion Criteria:

* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.

The aim of this study is to evaluate the efficacy of a support program in community pharmacy on the improvement of the compliance to antidepressants and the clinic of typical primary care patients under normal practice circumstances. That implies that the intervention is made by pharmacists without any specific requirement that work in the community pharmacies set up in the area of study and on patients following the usual medical circuit. As well, the cost of the support program is calculated in order to set the effectiveness of the program.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for depression from a general practitioner
* Beginning a pharmacological antidepressant treatment
* Going to one of the participant community pharmacies

Exclusion Criteria:

* Used antidepressant medication in the past 2 months
* Had an appointment with an specialist in mental disorders in the past 2 months
* History of psychotic or bipolar episodes
* History of drug abuse or dependency
* Cognitive impairment that not allows assessment
Psychometric Validation of the Camouflaging Autistic Traits Questionnaire

For many affected individuals, despite impairment and distress, autism spectrum disorder (ASD) is recognized and diagnosed late, in school age, adolescence, or even in adulthood, which could be due, among other things, to the use of compensatory strategies such as so-called "camouflaging" by the respective individual. In order to better investigate and quantify these adaptive and compensatory strategies of individuals with autism, the Camouflaging Autistic Traits Questionnaire (CAT-Q) has recently been developed and validated in the English-speaking world. The CAT-Q is designed to assess the extent of camouflaging behavior, in which autistic individuals consciously or unconsciously attempt to conceal or attenuate their autistic traits in order to better adapt to social situations. So far, however, there is no German-language questionnaire that can be used to validly assess camouflaging. The aim of the planned research project is to psychometrically validate the CAT-Q in German-speaking adolescents aged 13-21 years. The validation of the CAT-Q represents an important basis for further research on the construct camouflaging and can subsequently contribute to an improvement of diagnostics as well as support the development of individual treatment approaches.


Eligibility Criteria:
Inclusion Criteria study group:

- patients who meet the principal diagnosis of ASD, which includes atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5), and are between the ages of 13 and 21 years old.

Exclusion Criteria study group:

* Dementia / below average cognitive abilities (IQ \< 85)
* lack of German language skills
* severe visual or hearing impairment (uncorrected)

Inclusion Criteria control group:

- Adolescents who do not have a lifetime principal diagnosis of a psychiatric disorder (ICD-10-GM-2016: F10 - F69) and are between 13 and 21 years old.

Exclusion Criteria Control Group:

* dementia / below average general cognitive ability (IQ \< 85)
* lack of German language skills
* severe impairment of vision or hearing (not corrected).
Antibiotic Treatment of Multiple Erythema Migrans

The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

* multiple erythema migrans in patients \> 15 years

Exclusion Criteria:

* a history of Lyme borreliosis in the past
* pregnancy or lactation
* immunocompromised status
* serious adverse event to doxycycline or beta lactam antibiotic
* taking antibiotic with antiborrelial activity within 10 days
STAND Community College Tobacco Cessation Trial

Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.

This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.


Eligibility Criteria:
Inclusion Criteria:

* adult 18 years or older
* current smoker in the past 30 days
* smoker wants to quit
* smoker not currently participating in other smoking cessation activities, and
* smoker must be willing to accept randomization into any of the 3 study arms

Exclusion Criteria:

* students not proficient in communicating in English
* adults unable to consent