cyrilzakka/clinical-trials huggingface dataset:
Using Implementation Intentions to Reduce Cannabis Use

The study will recruit frequent users of cannabis (defined at least fortnightly use) and randomize them either to: (1) form implementation intentions by linking situations in which they are tempted to use cannabis with strategies to avoid using cannabis in those situations by using a volitional help sheet, or (2) to consider the situations in which they are tempted to use cannabis alongside possible strategies to avoid using it as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported cannabis use will be assessed 1 month post-intervention. Predictors of cannabis reduction will also be examined.

Design: This study will use questionnaires to assess participants cannabis habits (frequency and amount of use) and then employ planning strategies to help them quit. Follow up questionnaires will be used to ascertain the success of planning on reduction in cannabis use.

Sample Size: We plan to recruit a minimum of 60 participants in each condition (120 total) but aim to collect data from as many participants as possible.

Recruitment: To participate in this study a person must be over the age of 18 and a frequent user of cannabis. The study will be advertised online on social media platforms.

Procedure: Potential participants will follow an online link to a briefing sheet that provides information about the study. The sheet will also inform participants that they do not have to complete the questionnaire and that they can withdraw from the study at any time without giving a reason. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire online. A month after the participants have completed the initial questionnaire they will receive a link to a follow-up questionnaire via email. Email addresses will be stored separately to study data and will be destroyed once the follow up phase has completed and their involvement in the study ends.

Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to reduce cannabis use. Quantitative analysis will be conducted to assess the effects of planning on cannabis use reduction. The investigators expect to find that planning is effective in helping people reduce their use.

Eligibility Criteria:
Inclusion Criteria:

* Frequent cannabis user (at least fortnightly)

Exclusion Criteria:

* Younger than 18 years of age
* Infrequent / no cannabis use (less than fortnightly)
the Challenges of Young Adults With Cancer

The study aims to describe unmet needs of Adolescent \&amp;amp; Young Adults (AYA) with gastrointestinal and breast cancers in relation to: a) quality of life, b) education, c) finances and Insurance, and d) childbearing and parenting in Europe

An electronic online questionnaire was developed addressing four main areas: a) quality of life, b) education, c) finances and Insurance, and d) childbearing and parenting. In brief, the first part of the questionnaire will aim to examine the demographic characteristics of the participants, such as their nationality, gender, age at diagnosis, actual age, and level of education, followed by their diagnosis or condition. No clinical data will be collected other than these features. Then, each domain will include 10 questions (multiple choice questions, ranking questions and 7-point Likert scale questions) and investigate the unmet needs in AYA with gastrointestinal and breast cancers.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years old at survey participation, as long as aged 13-39 years old at diagnois;
* Gastrointestinal cancer (colorectal, gastric, pancreatic) or breast cancer.

Exclusion Criteria:

* Age: 18 years old at survey participation;
* Patients 13 - 39 years old at diagnosis;
* Hematologic malignancies or different cancers.
Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment

The goal of this two-group parallel randomized controlled study is to determine the effect of a web-based mind-body-based awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment.

Developing fertility awareness in women receiving infertility treatment can enable changes in lifestyle habits that can increase fertility. Having and increasing fertility awareness in infertile individuals can increase the likelihood of pregnancy and having a healthy pregnancy, positively affect general health and reproductive health, and change negative lifestyle habits that can affect the treatment process for infertility. Fertility readiness can be provided with fertility awareness and can positively affect treatment outcomes. This research will be conducted as a two-group parallel randomized controlled trial to determine the effect of a web-based mind-body awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment. The research will be conducted with women receiving infertility treatment at the In Vitro Fertilization Unit of Hacettepe University Faculty of Medicine. The sample will include women who volunteer to participate in the study, have started the infertility treatment process, have had at most two IVF attempts, speak and understand Turkish, are at least primary school graduates, are not in any psychological or social support group, have not completed or are not currently participating in any mind/body program for fertility. A total of 78 women will be included in the study sample: 39 for the intervention group and 39 for the control group. The Introductory Information Form, Fertility Awareness Scale, Fertility Readiness Scale, and Satisfaction Evaluation Form will be used to collect the data. Within the scope of the study, a web-based mind-body awareness program based on Meleis transition theory will be applied to the women in the intervention group. The routine nursing care in the unit will be applied to the control group. Research data will be analyzed using mean, standard deviation, median, quarts, percentage, minimum and maximum values, Chi-square, and Mann Whitney-U tests.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research
* Being diagnosed with primary infertility
* Starting the infertility treatment process
* Having attempted IVF at most twice before
* Being able to speak and understand Turkish
* Being at least a primary school graduate
* Not taking part in any psychological or social support group.
* Not having completed or currently participating in any mind/body program for fertility.

Exclusion Criteria:

* Women applying for frozen embryo transfer without ovarian stimulation
* Being diagnosed with secondary infertility
* Having a diagnosis of a chronic disease
* Having communication problems (vision, hearing)
Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis

Knee osteoarthritis (OA) is a common problem in clinical settings. Knee OA is well known for its association with the wear and tear of the cartilage and osteophyte formation. Evidence has suggested the importance of the infrapatellar fat pad, known as Hoffa's fat pad, during the development of knee OA. Some studies have demonstrated the protective role of the infrapatellar fat pad, whereas others have suggested an inflammatory role such as increased fibrosis and proinflammatory cytokine levels. Ultrasound is exceptionally convenient in the assessment of the musculoskeletal system, and elastography is a tool to evaluate tissue texture. Therefore, in this study, we investigated the Hoffa's fat pad in knee OA patients by using elastography.

This was an observation study that included a control group. We enrolled 20 patients with knee OA, as well as 10 healthy individuals. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Kellgren-Lawrence X-ray grading were employed to determine disease severity. All the study participants received elastography assessment, including strain and shear wave elastography in the knee extension and flexion position. The strain elastography contained color mapping that enabled the calculation of the relative texture and strain ratio. The shear wave elastography revealed the qualitative velocity, which was measured 3 times. Each patients with knee OA received elastography examination twice: once before hyaluronic acid injection and once 1 month after the injection.

Eligibility Criteria:
Inclusion Criteria:

OA group

* Kellgren-Lawrence grading I-IV proved by knee X-ray Healthy group
* No knee pain or received injection during the past 1 year
* No history of knee OA

Exclusion Criteria:

* History of knee surgery, trauma or malignancy
* History of patellar tendinopathy or patellofemoral pain syndrome
* Refused informed consent
Predicting Insulin Resistance in American Indian Youth

The purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific positive indicators of insulin resistance are present, individuals are recruited back in one year for repeat of all measures.

Type 2 diabetes is rapidly becoming more prevalent in the United States but especially among minority populations at a younger age. Identification of risk factors, including traditional risk factors such as increased BMI, lack of exercise, increased glucose in the diet, higher blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or other drugs has not previously been done with minority youth. If risk factors can be identified, more strategies for prevention of diabetes can be developed that specifically target this population. This study will enroll 300 Native American Youth over a 4 year period and perform body measurements including height, weight, waist circumference, blood pressure and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin creatinine ratio test. In addition, subjects will be asked to identify behavior and feelings of stress in everyday lives. Subjects who are determined to be at increased risk of developing diabetes will be asked to repeat the tests in one year. The results will be reported to the tribal council to help determine prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

* Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.

Exclusion Criteria:

* Those who have diabetes previously identified or those with chronic steroid use, or identified conditions that affect weight balance such as cancer.
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
* Must have telephone access.

Exclusion Criteria:

-
A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura

This is an open label 6 month pilot study for male and female participants over the age of 52 that desire treatment and prevention of senile purpura of the forearms.

This study will be evaluating the effects of Adapalene 0.3% for the use in the treatment and prevention of senile purpura.

This is a new potential use for the product Adapalene 0.3%, which is currently an FDA approved topical treatment used for the treatment of acne.

Senile purpura is a common sign of aging that appears in the form of dark blotches on the skin and is caused by bruising.

Older adults tend to be more prone to bruising, since as people age, their skin becomes thinner and more fragile.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 52 years of age with signs of senile purpura on either the right or left (or both) dorsal hand \& extensor forearm and desire treatment for this condition that is associated with aging.
* Women who have had hysterectomies, tubal ligations or who are post-menopausal for at least one year prior to the study may be enrolled. Women of childbearing potential who are not pregnant, not planning to become pregnant during the study period, and not lactating may be enrolled if they are using a medically accepted contraceptive program initiated at least one month prior to study entry and continued during the study.
* Subject is willing to comply with study instructions and return to the clinic for required visits.
* Subject is able to understand and has signed an IRB approved informed consent form including consent for photography.

Exclusion Criteria:

* All subjects on coumadin, heparin, plavix, supplemental herbs, vitamin E, empirin, fiorinal, norgesic, forte, percodan, robaxin, nuprin, ansaid, anaprox, clinoril, dolobid, feldene, naprosyn, voltaren, fish oil, oral steroids, or daily use of aspirin, Motrin, or Advil. (PRN usage not excluded)
* Prior treatment with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids within 3 months of study enrollment is prohibited.
* Clotting abnormalities as determined by screening labs
* Any history of a stroke or unstable heart disease
* Participation in another clinical trial with exposure to any investigational agent within 30 days prior to Screening Visit.
* Any condition the Investigator believes would interfere with subject's ability to provide informed consent, comply with study instruction, or which might confound the interpretation of the study results or put the subject at undue risk.
* Subject is pregnant, breastfeeding or planning a pregnancy during the study.
* Subject is unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking).
* Subjects who are allergic to adapalene or the ingredients in the gel.
Virtual Teaching Kitchen

A novel way of delivering nutritional education is through experiential learning in a teaching kitchen setting. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had improved cardiac health.

Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity and its consequences. This includes a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established three-pronged approach places our institution in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population.

Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV-2, the investigators are proposing a study where patients can benefit from nutritional education virtually. Patients with food insecurity and metabolic syndrome who utilize the food pantry will be invited to an educational program conducted on zoom. The program will be run by a registered dietician and chef who will deliver education virtually. Data will be collected using surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this program improves cardiac health in patients.


Eligibility Criteria:
Inclusion Criteria:

* Users of the food pantry
* English speaking
* Must have one of following on their EPIC problem list (Diabetes mellitus, obesity, hypertension, hyperlipidemia or obstructive sleep apnea)
* Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention.

Exclusion Criteria:

* Patients with advanced dementia or uncontrolled psychiatric disease
* Non-english speakers since education delivered in the pilot in English
* Uncontrolled medical illness including hypertension, recent acute coronary syndrome, active malignancy or other condition that would make the subject unable to complete the study procedures
Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19)

It is a randomized controlled clinical trial study that aims to follow a sample of individuals with persistent olfactory dysfunction post-COVID-19. The aim of this study is assess the clinical outcomes of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19. The sample will consist of 350 participants, being 300 individuals with persistent olfactory dysfunction post-COVID-19 and 50 healthy individuals. Volunteers' will be separated in two experimental groups (1 and 2 ) and a control group. All participants will be submitted to clinical evaluation that include the Connecticut Chemosensory Clinical Research Test (CCCRT), an olfactory test to diagnose anosmia and hyposmia, and two skull Magnetic Resonance imaging (MRI). Only participants of Experimental group 1 will be submitted to an olfactory training with essences oils. Experimental group 2 will only receive a clinical follow-up after three months and control group will be only submitted to neurological exam, olfactory test, MRI imaging and test their ability to discriminate the essence oils used in olfactory training. As a result, is expected a better understanding of the characteristics of olfactory dysfunction caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus infection, as well as the effectiveness and viability of using Olfactory Training as a therapeutic alternative.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COVID-19 by Real Time Polymerase chain-reaction for SARS-CoV-2 or serological tests for SARS-CoV-2 antigens.\\
* Olfactory dysfunction confirmed by Connecticut Chemosensory Clinical Research Test (CCCRC-T).

Exclusion Criteria:

* Smokers
* Individuals with diagnosed rhinitis
* Individuals with diagnosed Neurological diseases
* Individuals submitted to brain surgery
* Previous historic of hyposmia and/ or anosmia
* Pregnancy
* Allergy to any of the substances present in the olfactory test kit
* Individuals who are undergoing another treatment for olfactory dysfunction
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk

This brief alcohol and sexual risk taking intervention has the potential to influence the public health by reducing alcohol use and sexual risk taking behavior in individuals who are seeking treatment in an Emergency Department.

Linkages between alcohol use and HIV/sexual risk behaviors have been observed in multiple groups and each behavior has been successfully treated individually. Indeed, some studies suggest these behaviors can be successfully treated together. The Emergency Department (ED) provides a venue through which many patients with multiple risks are treated. Yet, to date no study has addressed these behaviors together in an ED, where admission may represent an opportunistic moment when patients are particularly willing to discuss these risky behaviors. Motivational Interviewing (MI) has demonstrated promise with alcohol risk in the ED in several of our previous studies, and has shown promise with sexual risk populations as well. Accordingly, this study (N=302) will address whether a one session multiple risk MI can more effectively decrease and maintain reduction in alcohol use, alcohol related problems, and sexual risk taking following discharge from the ED than Brief Advice (BA). Baseline, MI Session 1 and BA will be administered in the ED. Follow-ups will be conducted at 3, 6 and 9 months. This project will allow us to address the next phase of our program of research that has been designed to develop easily disseminable treatments for high-risk populations in medical settings. This study will also address potential mediators (motivation to change risk taking, self-efficacy) of MI effects. We will also examine whether reductions in sexual risk associated with MI compared to BA are accounted for by reduced drinking. A tertiary aim will examine the moderating effect of co-occurring substance use on outcomes. The cost-effectiveness of the interventions will also be addressed. Thus, this study will address two significant Public Health problems and provide significant information about MI mechanisms that may be relevant to the treatment community.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients older than 18 who receive medical care in the ED \*score positive (\> 8 for males; \> 6 for females) for harmful alcohol use on the AUDIT screening questionnaire and report past 3-month binge drinking

  * be sexually active (past 6 months)
  * endorse any past-year sex-risk behavior criterion, including:

    * having more than one sexual partner
    * having sexual intercourse without a condom
    * consuming alcohol prior to or during sex
    * sing illicit drugs (or using licit drugs to get high) prior to or during sex.

Exclusion Criteria:

* Patients under the age of 18; Patients in a mutually monogamous relationship for longer than 1 year will be excluded unless either the patient or his/her partner are HIV+ or has unknown HIV status. Other exclusion criteria include:

  * scoring below 18 on a mini-mental status exam
  * no verifiable address
  * plans to move outside a 45-mile radius within the follow-up period.