cyrilzakka/clinical-trials huggingface dataset:
Mobility Hypertension Management Study

The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care.

Although, meta-analysis confirms that BP telemonitoring may represent a useful tool to improve hypertension management, the strength of the provided evidence is limited. Therefore, future well-designed, large-sample, prospective, controlled trials are mandatory to understand the benefit of BP telemonitoring.

Recently, a specific telehealth solution for hypertension management has been developed in France (Hypertension Monitor - e-CoreLab®).

The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care.

The primary objective: To evaluate whether a home telehealth system can improve BP control and other risk factors in hypertensive individuals, as compared to the standard care.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Age between 18 and 80 years
* Patients with essential moderate Hypertension
* untreated or not adequately treated (need for treatment changes)
* Given written informed consent

Exclusion Criteria:

* Severe Hypertension (\>180/110 mmHg)
* Difficulties to perform home blood pressure measurements
* Patients with arm circumference \> 42 cm
* Night shift workers
* Body mass index \> 35 kg/m²
* Atrial fibrillation and/or another arrhythmia
* Pregnancy
* Cardiovascular events (stroke, Myocardial infarction) in the last 6 months
* Severe Sleep Apnea Syndrome
Discussing COVID-19 Vaccines in Private Facebook Groups

As the COVID-19 pandemic persists, a sizable proportion of the U.S. population remains unvaccinated and at high risk of death and serious illness from COVID-19. Vaccine hesitancy, fueled by the proliferation of vaccine misinformation on social media, is one factor contributing to lack of vaccination. Current attempts to overcome vaccine misinformation focus on correcting or debunking falsehoods. Although debunking strategies are important components to any public health campaign, communications must also address rationales for vaccine hesitancy that vary among individuals and communities, and directly address the gist of their concerns in an empathetic, non-judgmental manner. We will conduct a randomized controlled trial to test the effectiveness of empathic, relationship-building interactions relative to standard provision of information on social media to address COVID-19 vaccine hesitancy.


Eligibility Criteria:
Inclusion Criteria:

* reside in the U.S.
* unvaccinated from COVID-19
* Use Facebook regularly (at least 1/day)

Exclusion Criteria:

* age \<18 years
* do not reside in the U.S.
* vaccinated from COVID-19
* do not use Facebook regularly (at least 1/day)
Metformin Therapy in HCV Infection

Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection.

A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"


Eligibility Criteria:
Inclusion Criteria:

* Adult Males and Females (18-70 yrs old) able to give consent
* Chronic hepatitis C virus infection
* Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study; (e.g.intra-uterine device (IUD) or a double-barrier method of oral contraception with condom)

Exclusion Criteria:

* Type 2 diabetes.
* Patients with impaired renal function.
* Decompensated liver cirrhosis (stable patients with cirrhosis would be eligible).
* Patients who in the opinion of the Investigator are considered unsuitable.
* Pregnant females.
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation

In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Eligibility Criteria:
Inclusion Criteria:

* Patient who are scheduled for colonoscopy

Exclusion Criteria:

* pregnancy,
* breast feeding,
* known or suspected bowel obstruction, and
* known allergy to PEG or Itopride ,
* presence of severe illness(renal failure, congestive heart failure, liver failure,), and
* refusal of consent to participate in the study
Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards

Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥18 years
* Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy

Exclusion Criteria:

* Type 1 diabetes, gestational diabetes
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
* Pregnancy
* Any mental condition rendering the patient incapable of giving his consent
* Known or suspected allergy to insulin glargine or insulin aspart
* Continuous parenteral nutrition
* Participation in another trial which can influence the software algorithm
Bridging Community Gaps Photovoice

The purpose of this study is to test a peer-led intervention intended to promote the community living and participation of individuals with psychiatric disabilities entitled "Bridging Community Gaps Photovoice" (BCGP). The intervention targets increasing community involvement of individuals with psychiatric disabilities through reduction in self-stigma and perceived stigma, enhancing opportunities for community participation, and support to achieve community participation goals.

The BCGP intervention is 6 months long and the investigators expect that participants will experience lower self and perceived stigma, increased community participation and sense of belonging, and improved psychosocial functioning and personal growth after the intervention. The intervention is comprised of a 12-week class that meets once a week for two hours, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone. The purpose of the individual support is to reinforce the class activities and to ensure the participants meets their community participation goal. The proposed study is a randomized trial which will be conducted at Boston University Center for Psychiatric Rehabilitation (BUCPR) in Massachusetts, the Mental Health Center of Denver (MHCD) in Colorado, and the Greater Bridgeport Mental Health Center (GBMHC) in Connecticut.

Eligibility Criteria:
Inclusion Criteria:

1. are 18 or older.
2. are recipients of services at research sites due to having a DSM-V diagnosis of mental illness, including dual diagnosis (dual diagnosis refers to co-occurring mental illness and alcohol/ substance use disorder).
3. are interested in enhancing their community participation.
4. are not currently receiving individual peer support services.
5. are able to read and write in English.

Exclusion Criteria:

1)Inability to give full and knowing consent.
Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children

Alopecia is a common, distressing condition that is sometimes difficult to diagnose and treat.

Losing hair is not usually health threatening; it can scar a young child's vulnerable self-esteem by causing immense psychological and emotional stress, not only to the patient, but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed and treated early to overcome the resulting problems.

The majority of alopecia in children is presented as patchy alopecia, which is most commonly diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis, trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis congenita (ACC) can be easily missed.

Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye.

Trichoscopy allows visualization of hair shafts at high magnification and performing measurements, such as hair shaft thickness, without the need of removing hair for diagnostic purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and perifollicular epidermis.

The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be accepted by children and their parents.

Tinea capitis and alopecia areata are considered to be the most common causes of hairless patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same clinical appearance of alopecia areata, so trichoscopy has recently become a useful diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab investigations like fungal culture or biopsy may take several weeks.

Eligibility Criteria:
Inclusion Criteria:

-age from 3-18 years of both sexes with focal non-cicatricial alopecia.(1-5 patches of alopecia)

Exclusion Criteria:

1. Patients who will not consent.
2. uncooperative children.
3. patients with active secondary bacterial infection in the alopecic patch.
4. patients with any concomitant dermatological diseases.
5. history of using any topical(1 month) or systemic treatment (3 month) for tinea capitis or alopecia areata prior to the study,
6. cicatricial alopecia.
Pre-hospital Tourniquet in Extremity Injury

2.1. Objective:

• Primary Objective: To compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement.

2.2. Study Outcome Measures

* Primary Outcome: Incidence of arrival in shock (SBP \<90)
* Secondary Outcomes: Demographics, comorbidities, mechanism of injury, cause of injury, diagnosis codes, procedure codes, Injury Severity Scale, Abbreviated Injury Scale, operative management vs. non-operative management, radiologic findings, pathologic findings, tourniquet effectiveness (as determined both subjectively by trauma surgeon and objectively by presence vs. absence of pulse below level of tourniquet application), total number of units of blood products transfused within first 24 hrs, total number of units of blood products for index admission, type of blood products or other fluid given, hospital length of stay, ICU length of stay, ventilator days, infectious complications, other complications, discharge disposition, 24 hr mortality, overall mortality.

This is a prospective, observational study. All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons. Data collected will include basic patient demographics, data regarding the patient's injuries, data regarding tourniquet use, and data regarding outcomes. Please see the attached data collection tool for specifics (Appendix 12.1). Data will be collected prospectively in an observational manner using the data collection tool. Data collected on individual collection sheets will be de-identified. We plan to complete the data collection and analysis by 01\\01\\2021.

Eligibility Criteria:
Inclusion Criteria:

≥ 18 y/o Patients with extremity injuries

* With a tourniquet in place OR
* Who the treating physician deems could have benefited from tourniquet placement

Exclusion Criteria:

* Children
* Prisoners
* Pregnant women
* Patients with non-traumatic bleeding requiring tourniquet use
Cannula-based Versus Needle-based Subcision for Posttraumatic Atrophic Facial Scars

This study aims to evaluate the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars

In addition to cosmetic issues, atrophic scars can lead to psychological issues like social isolation, low self-esteem, and embarrassment. Subcision (Subcutaneous incision-less surgery) has been used for years to treat a variety of skin depressions, including atrophic acne scars and other depressed scars. Numerous modifications have been made throughout time to this surgical method to make it easier and more efficient. Although needle subcision is a straightforward, simple, useful, and practical procedure, it has many side effects and the overall success in this procedure is mild to moderate. So, in this study we evaluated the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients (\> 20-years old) with posttraumatic facial scar

Exclusion Criteria:

* other types of scars (e.g; postacne scars), pregnancy, lactation, bleeding or coagulation disorders, liability for keloid formation, history of kobnerization, and patients with systemic diseases (cardiac, chronic renal diseases, chronic liver diseases, asthma and hypertension) at the time of recruitment.
Ketamine in Refractory Convulsive Status Epilepticus

To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
* Refractoriness of the drug I and II line
* Written informed consent from parents or legal guardian.
* Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.

Exclusion Criteria:

* contraindications to the use of the medication/s in the study.
* pregnant or suspected pregnant.
Candin for the Treatment of Common Warts

The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:

* does treatment with Candin result in better clearance of warts than placebo
* how many injections are required to result in wart clearance Participants will
* have one wart selected for injection every two weeks until clearance
* return 12 weeks after wart clearance for assessment of durability of response

This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.

Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 3, but not more than 20 common warts (Verruca vulgaris)
* Willing to agree to use adequate contraception methods during the study

Exclusion Criteria:

* Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function
* Candin delayed type hypersensitivity reaction test wheal sized \< 5 mm or \> 25 mm at the Baseline Visit
* History of keloid formation
* Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment
* Treatment with immunotherapy (e.g., diphenylcyclopropenone \[DPCP\], dinitrochlorobenzene \[DNCB\], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study
* Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study
* Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids \[topical or inhaled steroids are acceptable\]).
* Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study
Dermatoscopy Guided Resection for Skin Cancer

In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma

Exclusion Criteria:

* Recurrent tumours
* Previous radiotherapy of the tumour area
* If the patient cannot understand the study i nformation
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.

The main purpose of this study is to determine the effect of consumption of purple wheat anthocyanin-rich products for eight weeks by human participants with an elevated level of chronic inflammation, on oxidative stress and inflammatory responses as measured by select plasma biomarkers.

This study will investigate the effect of daily consumption of purple wheat bran-enriched wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and plasma antioxidant capacity. This study is a randomized, parallel arm study with 20 men and 20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of the study. The participants will be randomly divided into two groups, using stratification for matching sex and screening hs-CRP level to be equally distributed in each group, and assigned to either the treatment group or control group. Both group will have a 10 day diet run-in period where consumption of foods rich in anthocyanins and phenolic acids will be limited. Both groups will consume 4 servings of wheat products per day for 8 weeks and will replace 4 grain servings from their typical daily intake with the study treatment products. Fasting blood samples will be collected during three study visits, including baseline, for the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity. The plasma metabolites of anthocyanins and phenolic acids will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25 kg/m2 and/or Waist circumference ≥102 cm (men) and ≥88 cm (women)
* hs-CRP: ≥ 1.0 mg/L at time of screening
* Stable (\>3 months) and consistent use of all prescribed medications and/or supplements
* Non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week)
* Not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months

Exclusion Criteria:

* Pregnant or breastfeeding females
* Lifetime history of any acute medical event, including but not limited to, heart attack or stroke
* Occasional or intermittent smoker (includes but not limited to tobacco and cannabis)
* Consistent smoker of \<1 year
* Recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis
* Recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression
* Any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or Celiac disease
* Any food allergies or any life-threatening allergies, food or otherwise
* Regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc
* Difficulty providing blood samples