cyrilzakka/clinical-trials huggingface dataset:
The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge

HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.

Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?

Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.


Eligibility Criteria:
Inclusion Criteria:

* Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.

Exclusion Criteria:

* Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.
The Gut Microbiome in Adult Multiple Sclerosis

This study aims to assess the following research questions:

1. Map and benchmark the gut microbiome of patients with RRMS, and PPMS versus matched healthy controls
2. Determine whether RRMS or PPMS have a unique bias for a gut microbiome classification recently characterized.
3. Search for relationship with inflammation, amino acid plasma levels, heart rate variability (vagus nerve tone) and hair cortisol as a biological marker of chronic stress
4. Determine whether the gut microbiome is different in MS patients during a relapse.
5. Determine whether the gut microbiome remains stable after 3 months

This study is a prospective multi-center cohort study (University Hospital Brussels, National Multiple Sclerosis Center Melsbroek). This is an exploratory study and there is no specific outcome on which a power calculation can be made. We will include different subgroups of patients with MS: stable non-benign RRMS, PPMS, benign MS \[Benign MS is defined as RRMS with an EDSS ≤ 3, 15 years after disease onset\], RRMS during a relapse (before the administration of corticosteroids) \[Relapses are defined as the development of new or recurrent neurologic symptoms not associated with fever or infection or change in medication, lasting at least 24 hours, and accompanied by new, objective neurologic findings\]. Age and sex matched healthy controls will be included as well. All participants will provide a faecal, hair, and blood sample twice (baseline and after 3 months). Patients will be assessed clinically at baseline, 3 months after baseline, and approximately 1, 2, 4.5 years after baseline.

The results of this study have the potential to identify novel simple strategies to strengthen or alter the microbiome ecosystem and strengthen the overall treatment process. In case of a positive result, this would form the basis for a follow-up study on medical modulation of the microbiome with the aim of finding new treatment options for MS.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. RRMS or PPMS, as defined by the McDonald criteria.
3. Ages 18-65 years.
4. EDSS \< 7
5. Treatment with IFN-beta

Exclusion Criteria:

1. SPMS without relapses during the past year at screening.
2. Use of high dose systemic steroids within the last 2 months.
3. Gastrointestinal disease, such as inflammatory bowel disease
4. Use of antibiotics within the last 4 weeks.
Study of Sulphoraphane in Chronic Kidney Disease

The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease.

In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.

We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in chronic kidney disease (CKD) patients. To test our hypothesis, we will first perform a randomized, Phase 1 clinical trial in a single center funded by an R01 NIDDK award. This is an interventional pharmacokinetic trial, with subjects randomized to different doses of Avmacol ES.

Eligibility Criteria:
Inclusion Criteria:

* eGFR ≥ 20 and \<60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
* Blood pressure \<140/90 mm Hg prior to initiation of sulphoraphane
* stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
* able to provide consent
* able to swallow capsules

Exclusion Criteria:

* significant co-morbid conditions with life expectancy of \<1 year
* uncontrolled hypertension
* serum potassium of \>5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
* factors judged to limit adherence to interventions
* current participation in another study
* pregnancy or planning to become pregnant or currently breastfeeding
* history of dementia
* on anticoagulants or immunosuppression
* under treatment for cancer
Retrospective-Prospective PNS Study

This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.

A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.


Eligibility Criteria:
Inclusion Criteria:

A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.

Exclusion Criteria:

A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.
Empower Korean Families to End Tobacco Use & Smoking Exposure

The goals of the study are to develop a culturally and linguistically appropriate intervention to promote smoking cessation and reduce secondhand smoke exposure for Korean Americans using a family-based intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a randomized control trial targeting a total of 8 lay health workers (LHW) and 48 dyads of a daily smoker and a partner who will attend intervention sessions together. The research question is: Can a family-based lay health worker outreach intervention promote smoking cessation and reduce SHS exposure among Korean Americans?


Eligibility Criteria:
Inclusion Criteria:

* reside in California, United States
* for the smoker participants, they must have smoked at least 1 cigarette in the past 30 days, and have smoked either at least 1 cigarette and/or used e-cigarettes in the past 7 days, and self-identified as Korean or Korean American
* for partner participants, they must be willing to attend intervention session together with a smoker participant
* provide a valid contact telephone number and email address for pre- and post-intervention assessments
Community Based Prevention/Control Project

This project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. The project will develop and implement a community-wide intervention to reduce the transfer of pesticides from the workplace to the home (take home pathway).

This project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. Since 1991 our group has investigated pesticide expsoures among children of agricultural families in Washington state, focusing on exposure to organophosphate insecticides. We have demonstrated in these studies that the residential environments of agricultural families have higher pesticide residues than do other homes in this region. We have also found that children living in these residential environments have elevated levels of pesticide metabolites in their urine. We need to better understand how these children are being exposed in order to develop recomendations for exposure prevention or reduction. The current project will develop and implement a community-wide intervention to reduce the transfer of pesticides from the workplace to the home (take home pathway). A complementary project is also underway by the UW-Child Health Center to characterize pesticide exposure pathways for children of farmworkers.

Eligibility Criteria:
Each family recruited must include one child between the ages of 1-5. Recruitment will be confined to the lower Yakima Valley.
Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements

The aim of this study is to test whether when using the Vestibular Rehabilitation App older patients perform rehabilitation in a similar manner as when directly instructed by a clinician. A secondary goal is to evaluate usability and enjoyment of the app.

The main aim of this study is to test the prototype Vestibular Rehabilitation App (that has been specifically developed for this study) in the lab setting to evaluate if patients perform exercises with the app in a similar manner as when performing exercises in the traditional manner without the app. Errors in exercise performance identified by the app will be compared to those identified by a physical therapist. A secondary aim is to get feedback on enjoyment and ease of use of the Vestibular Rehabilitation App.

Eligibility Criteria:
Inclusion Criteria:

* aged between 60 and 75
* Presence of dizziness due to a central or peripheral vestibular disorder

Exclusion Criteria:

* Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
* History of recent lower extremity surgery or severe pain in legs
Effects of a Mindfulness Meditation App on Subjective Well-Being in Undergraduate University Students

Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.

Background: Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.

Methods: Undergraduate students completed 3 weeks of mindfulness training with Wildflowers or 3 weeks of cognitive training with a game called 2048. State training effects were assessed through pre- and postsession ratings of current mood, stress level, and heart rate. Trait training effects were assessed through pre- and postintervention questionnaires canvassing subjective well-being and behavioral task measures of attentional control and interoceptive integration. State and trait training data were analyzed in a multilevel model using emergent latent factors (acceptance, awareness, and openness) to summarize the trait questionnaire battery.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected-to-normal vision and hearing
* Be fluent in english
* Own an iPhone, iPad, or iPod with access to the internet
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China

This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.

Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
2. The informed consent form is signed.
3. A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
4. ECOG performance status is 0, 1 or 2.
5. The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
6. The patient is aged≥18

Exclusion Criteria:

1. The patient is known to be allergic to any study drug.
2. The patient is recruited in other clinical study or is planned to participate into other clinical study.
3. The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
Postural Control in Degenerative and Inflammatory Diseases of the Hip

Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of our study is to determine the postural control in patients suffering from OA and RA of the hip joint during different conditions, i.e., on both stable and compliant surfaces with opened or closed eyes to determine the possible differences between these two diseases in this respect.

Determination of functional status, using the following outcome measures: Harris Hip Score, the Functional status of the hip joint is rated with the Harris Hip Score (HHS), Visual Analogue Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up \& Go test.

Posturography measurements, Postural control tests

The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability \[displacement of Centre of Pressure (CoP)\] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room. Signals were amplified and sampled at 16 Hz via an analogue-to-digital converter. Subjects stood barefoot on the platform, with the feet positioned side by side and arms hanging freely at their side. Toe-out was positioned to subjects' comfort. The CoP excursions along antero-posterior (AP) and medio-lateral (ML) axes were performed both on firm (the stable surface of the platform) and foam surfaces \[an Airex Balance Pad (dimensions: 50 cm length x 41 cm width x 6 cm height) placed on the platform\], always starting with standing on the stable surface. In each condition, subjects had to stand first with the eyes open (EO), when subjects had to look at a target fixed at eye level at a distance of approximately 1 m, and then measurements were also performed with closed eyes (EC).

Eligibility Criteria:
Inclusion Criteria:

* C-reactive protein and Westergreen values had to be under the upper level of the normal values.
* Patients should have unilateral hip pain on most of the days for several months
* Controls should have no hip pain or functional impairment in the hip joint or any other joint of the lower extremities.

Exclusion Criteria:

* history of trauma to the hip joint or in the pelvic region,
* previous hip fracture or hip surgery,
* hip joint infection and congenital or developmental diseases
* any complaints in the other joints of the lower limbs
* any disease that could worsen their physical or balance parameters
* cancer,
* endocrine,
* cerebrovascular disease,
* Parkinson's syndrome,
* epilepsy,
* polyneuropathy,
* neuromuscular disorder,
* cardiovascular disease without medication,
* atherosclerosis of the lower extremities
Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.

No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years;
* That were never pregnant before;
* That wants to use LNG-IUD;
* Not pregnant at the time of insertion;
* No haematological disease;
* That do not have signs and / or symptoms of vaginal / cervical infection.

Exclusion Criteria:

* Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).
Investigation of the Relationship Between Taste Perception and Caries Activity in School Children

Four basic taste perceptions and relationship with caries are poorly investigated in children as compared to adults.

The aim of this study was to evaluate salty, sweet, bitter and sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.

Study design

1. Caries risk assessment The investigators developed a questionnaire to understand the patient's overall health status, to collect demographic and socio-economic information, to assess their oral health habits. The questionnaire consists of 3 parts; first part includes questions about general health such as chronic diseases, drugs and allergies, second part includes questions about income and education level of parents, and last part includes questions about oral health knowledge, habits, diet contents and frequency, fluoride exposure. the investigators allowed the parents to fill the questionnaire.

   After the questionnaire was filled, the investigators performed the oral examination using DMFT, DMFS, dft and dfs indices according to WHO. Then, the investigators determined the oral hygiene status with Sillness\&Löe Index (Silness ve Loe, 1964). the investigators estimated paraffin-stimulated salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts using CRT chairside kits (Ivoclar Vivadent, Schaan, Liechtenstein).

   In addition to initial questionnaire and oral examination, the investigators asked the patients to record their nutritional takings of 2 weekdays and 1 weekend day. the investigators estimated the caries risk profiles of all children using the Cariogram which is a computer-based program. Cariogram identifies three risk groups low, medium and high caries risk according the scores.
2. Taste evaluation the investigators prepared aqueous basic taste solutions of sucrose (Merck, Germany, purity \>99.5%), sodium chloride (Sigma-Aldrich, USA, purity \>99%), caffeine (Merck, Germany, purity \>99.5%), citric acid monohydrate (Sigma-Aldrich, USA, purity \>99%), at two levels (1.0 ISO, 2.0 ISO) (ISO 3972:1991, 8586-1:1993) (Table 1). the investigators formulated all the solutions by using spring water in the same day of measurement at room temperature (25 ± 2°C). Each solution was coded randomly.

Eligibility Criteria:
Inclusion Criteria:

- without any chronic disease such as diabetes and being ASA I or ASA II. We only included patients who had no antibiotics and drug intake within the last month.

Exclusion Criteria:

- chronic disease ASA III, IV antibiotic and drug intake within the last month