cyrilzakka/clinical-trials huggingface dataset:
Ginger and Gut Microbiome (GINGER)

Estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects..

This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal adenoma within the last five years. There will be 47-50 subjects in the treatment group and 47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of ginger extract per day (1000 mg twice a day) or matching placebo.

Subjects will provide three stool specimens for analysis of the intestinal microbiome over a 12-week period at the following intervals: Week 0 (Day 1), Week 6, and Week 12. Although the gut microbiome is stable within a period of 1-2 months, a control arm will be included to account for potential dietary and other changes that may affect the gut microbiome. Gut microbiome composition - the presence, abundance, and diversity of bacterial taxa - will be derived by sequencing microbial 16S ribosomal RNA genes.

Primary Aims:

Aim 1 is to estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects.

Aim 2 will examine the correlation between the ginger-related changes in microbiome profile with the levels of circulating biomarkers: urinary Prostaglandin E (PGE) metabolites.

Hypothesis: In the ginger versus placebo arm, gut microbiome will shift towards a lower proportion of pro-inflammatory, bacteria associated with colorectal cancer (CRC) and higher proportion of anti-inflammatory, CRC-protective bacteria.

Secondary Aim:

1. At the end of the study, we expect to show that ginger decreases the relative abundance of pro-inflammatory, CRC-predisposing taxa and increases the abundance of anti-inflammatory, CRC-protective taxa, i.e., demonstrate that ginger boosts changes in gut microbiome that are protective against CRC, as well as assess ginger-induced changes in immune response.
2. The similarities of bacterial profiles will be compared between three time points baseline and 6 Weeks and 12 Weeks to estimate whether 6-week is a sufficient time for washout.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal adenoma diagnosis

Exclusion Criteria:

* Allergy or sensitivity to ginger
* Active cancer
* Unstable medical condition
* Unstable diet or weight
Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates

Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* \> 18 years old
* Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV \& QRS width \> 120 ms milliseconds (ms) OR NYHA class II \& QRS width \> 150 ms
* Sinus rhythm
* First implant procedure

Exclusion Criteria:

* Permanent ventricular tachycardia
* Permanent pacing indication for 3rd degree atrioventricular (AV) block
* Diagnosed or suspected acute myocarditis
* Less than 1 year life expectancy related to a non-cardiovascular disease
* Impossibility to perform follow-up in the investigative center
* Pregnant woman
* Patient which may not cooperate to study procedures as evaluated by investigator
* Legally protected adult patient or patient unable to give an informed consent
* Patient enrolled in an other clinical trial
* Patient which does not benefit from a social protection system
* Renal insufficiency
* Patient registered on a heart transplant waiting list
* Disease and/or health condition which may interfere with study results
A Study of TRK-170 for the Treatment of Crohn's Disease

In Crohn's Disease Patients

* To evaluate the efficacy of TRK-170
* To evaluate the PK characteristics of TRK-170
* To assess the safety of TRK-170


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of Crohn's Disease before screening
* Patient has stable disease activity

Exclusion Criteria:

* Patient has had a clinically significant illness prior to screening
* Patient with clinically significant deviations in laboratory values
APPSPIRE App in Preventing Students From Smoking

This trial studies how well APPSPIRE, a smartphone app, works in preventing students from smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the potential to increase access to health behavior treatments and therapies, such as tobacco cessation support, and provide effective prevention messaging.

PRIMARY OBJECTIVES:

I. Develop a prototype of the APPSPIRE (phone application \[app\] of a smoking prevention interactive experience).

II. At post assessment, students enrolled in the study will qualitatively provide information about the usability and usefulness for the prevention and cessation sites.

III. Investigate frequency of use of and exposure to APPSPIRE modules via an objective measure of general use.

IV. Investigate how feasible the program will be. V. Obtain a maintained use of APPSPIRE with high completeness and extent of completion.

VI. Evaluate change in stage of change from baseline to about 1 and 4-month follow-ups among participants.

OUTLINE:

Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness.

Eligibility Criteria:
Inclusion Criteria:

* Student at Houston Community College (HCC)
* Speak and read English
* Own an iPhone
* Be enrolled in at least one class at HCC
* Provide current contact information
* Smoke 1 or more cigarettes a day (cessation group)
* Have access to the internet (cessation and prevention/advocacy groups)
* Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale

Exclusion Criteria:

* Does not plan to continue as a student at their campus sometime during the year of the study (cessation and prevention/advocacy groups)
* Current tobacco use (prevention/advocacy group)
Weight Reduction in CLBP

We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered online and will be a combination of online education material and face-to-face video calls with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.


Eligibility Criteria:
Inclusion Criteria:

* Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain
* Non-specific low back pain for at least 3 months' duration
* Currently seeking care for low back pain
* Native Dutch speaker
* Access to internet and computer/tablet/smartphone

Exclusion Criteria:

* Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
* Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
* Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
* BMI ≥ 40 kg/m2
* Being pregnant or given birth in the preceding year
* Currently receiving dietary or exercise interventions
Study of COVID-19 Outbreak in Hospital Departments of Bamako, Mali

The new coronavirus known as SARS-Cov-2 (severe acute respiratory syndrome -coronavirus 2) was first reported in December 2019 and rapidly became a public health emergency. The COVID-19 pandemic is now affecting sensitive regions with fragile health care systems, such as South America and Africa. Caregivers, in the front line of Covid19 patient management, may accidentally become infected and a source of infection during the incubation phase or in case of asymptomatic infection.

The objectives of this project are thus i) to assess SARS-Cov-2 spread over the hospital departments of Bamako by carrying out a systematic molecular screening of patients and caregivers, ii) to evaluate the feasibility of Point-Of-Care molecular assays in Mali and iii) to estimate the immunity acquired from SARS-Cov-2 among health workers through serological testing, allowing also the assessment of asymptomatic caregiver rate and absence of re-infection among the immunized caregivers. Finally, iv) variability of the virus over time and spread of different variants around the world will be studied by sequencing the viral genome.


Eligibility Criteria:
Inclusion Criteria:

* Free and informed consent accepted in writing
* Patient: patient hospitalized in one of the four hospitals of Bamako, with clinical signs of infection of the upper or lower respiratory tracts (sore throat, cough/sputum, nasal congestion and rhinorrhea, odynophagia, thoracic oppression, dyspnea, desaturation) with fever or feeling of fever or any other signs of SARS-Cov-2 infection (that is to say the following clinical manifestations, of sudden onset: unexplained asthenia, unexplained myalgia, headache without a known migraine disease, anosmia or hyposmia without associated rhinitis, dysgueusia, diarrhea, heart rhythm disorders, acute myocardial injury, severe thromboembolic event) or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures (FFP2/surgical masks or physical separation) and defined as follows: having shared the same place of life as the confirmed case, for example: family, same room or having a direct contact in face to face with less than 1 meter from the confirmed case during a talk; intimate friends; class or office neighbours; adjacent to the index case in a plane or a train; or having provided or received hygiene or care acts from a confirmed case.
* Caregivers: caregivers of one of the four hospitals of Bamako

Exclusion Criteria:

* Persons subject to legal protection or not able to give a free and informed consent.
* Caregivers: caregivers not able to follow the project schedule
Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.

OBJECTIVES:

* To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
* To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.

OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.

Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 4 years.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell lung cancer

  * Stage I or II disease (T1-3, N0, M0)

    * T2 or T3 tumor ≤ 5 cm
    * No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
* Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"

  * Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

Exclusion Criteria:

* No history of contrast allergy
* No psychological issues that would preclude the completion of study treatment

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or chemotherapy
* No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 \[FDG\]-avid or measure \> 1 cm in short axis diameter on CT scan)
* No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants

The goal of this clinical trial is to learn if breastmilk, massage or no intervention works for pain management during vaccination of term infants. It will also learn about the safety of these 3 approaches. The main questions it aims to answer is:

Does breastmilk, massage or no intervention works for pain management during vaccination of term infants?

Researchers will compare breastmilk, massage or no intervention for pain management during vaccination of term infants.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born at or after 37 completed weeks of gestation.
* Neonates scheduled to receive the DTC-HepB-Hib-1 immunization.
* Time from last feeding should be greater than or equal to 30 minutes.

Exclusion Criteria:

* Term neonates with major congenital abnormalities like limb contractures, limb deformities.
* Term neonates with any neurological conditions like hydrocephalus, cerebral palsy or birth asphyxia.
* Infants with acute illness.
* Infants randomized for no intervention but mothers breastfeed before pain evaluation to calm the babies from crying.
Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne

In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and sampling was done at start, 4, 8 and 10 weeks. Next-Generation Sequencing was used to analyze the skin microbiota of the patients.

Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies currently limited, but shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne (Murillo \& Raoult, 2013). In acne vulgaris it is known that the condition is multifactorial and that both hormonal triggers and environmental factors play a role. However, it is also known that Propionibacterium acnes play an important role in the inflammation of the sebaceous gland follicles. Probiotic strains with antipathogenic activity against this bacterium and suitable for application to the skin is thus potentially able to restore the balance of the skin microbiota and reduce acne symptoms.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate acne

Exclusion Criteria:

* local treatments, including cleansers, soaps, antimycotics and antibiotics within 2 weeks prior to start of study
* use of oral antibiotics within 4 weeks prior to start of study
* use of systemic retinoids within 6 months prior to start of study
Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).


Eligibility Criteria:
Inclusion Criteria:

* duration of type 1 diabetes longer than 12months,
* insulin pump therapy longer than 3 months,
* written informed consent to participate in the study signed by parents (and patient older than 16 years).

Exclusion Criteria:

* celiac disease,
* diabetes related complications (e.g. nephropathy),
* BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
* withdrawal of consent to participate in the study,
* comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.
Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners

Hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. However, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions.

Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all tumour localisations accepted) an 8-week groupal intervention combining hypnosis and self-care techniques.

Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right after the intervention of the experimental group, and right before the intervention of the control group) and again 3 months later (T3 - after the intervention of the control group). Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone application will be used to collect data. The indirect impact of the intervention on participants' partners will also be measured by questionnaires (emotional distress, conjugal communication).

Data collection has started on March 2017. Our results should bring new knowledge about the efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer patients, which are often under-diagnosed and under-treated, but also about the indirect efficacy to improve partners' well-being. Those results might contribute to spread this kind of inexpensive intervention in oncology settings.


Eligibility Criteria:
Inclusion criteria are:

1. age 18 years or older;
2. Fluency in French;
3. Having received a diagnosis of non-metastatic cancer (all tumour localisations accepted).
4. Having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy).
5. Not being in relapse at the time of inclusion
6. Exhibiting some difficulties as established by responses of at least 4 out of 10 on 1 of the 6 chosen items of the Edmonton Symptom Evaluation Scale (Chang, Hwang, \& Feuerman, 2000): physical fatigue, moral fatigue, depression, anxiety, fear of recurrence or ruminations).
7. Wishing to receive help in order to improve the difficulties identified.

Exclusion Criteria:

Psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations
The Effects of Therapeutic Recreation Activities on Aberrant Behaviours of Individuals With Intellectual Disabilities

The aim of this study was to determine the effect of Therapeutic Recreation Activities on Aberrant Behavior of Adolescents With Intellectual Disabilities.

The research was carried out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place between May 2019 and June 2019. The parents of the participants who participated in the study consisted of the experimental group (n = 16) and the remaining parents (n = 16) formed the control group and the sample group (n = 32). The personal information form which measures demographic characteristics developed by the researchers according to the literature, and The Aberrant Behavior Checklist Scale were used. Data were analyzed in SPSS statistics 23 program. According to Shapiro Wilk test, sample group was not normal. For this reason, non-parametric tests were performed. In descriptive data, the mean, number, percentage will be used; Comparative statistics were made according to the assumptions of non-parametric test (Wilcoxon test, Mann Whitney U test). Therapeutic Recreation Activities was applied as total of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour. The program was implemented by researcher.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Having a physical disability, Having Down syndrome