cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effect of Resistance Training for Breast Cancer Survivors

Persistent pain after treatment for breast cancer is a major clinical problem, affecting 25-60 % of the patients and is a source of considerable physical disability and psychological distress. Thus, the development of novel interventions to improve pain management for these patients is of clinical importance. Resistance training (RT) is a promising tool to combat a variety of undesirable adverse effects due to breast cancer treatment. Further, research suggests that it may also be able to provide pain-relieving benefits.

Hypothesis: Resistance training will improve pain perception and physical function in the short- and long term compared to a non-training control group.

Breast cancer is the most common cancer in women worldwide with more than a million new cases diagnosed every year \[1\]. Fortunately, due to better treatment options, the population of long-term survivors is increasing. This poses new demands for knowledge on how to manage late effects to the treatment regimen. Persistent pain after treatment for breast cancer is a common and underestimated problem as well as it can be a source of considerable physical disability and psychological distress \[2\]. Hence, the development of novel interventions to improve pain management is of high clinical relevance. Resistance training (RT) is a promising clinical therapeutic tool to improve a variety of adverse effects to breast cancer treatment \[3\] and may provide several pain-relieving benefits \[4\]. However, the efficacy of this modality for managing persistent pain after breast cancer treatment is currently unclear. Therefore, the purpose of this project is to investigate if individualized RT can modulate persistent pain after breast cancer treatment, thereby improving our understanding of how this modality may benefit patients and contribute to clinical guidelines for pain management in this clinical population.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of breast cancer (grades I-IIIA).
* adult women at least 18 years of age.
* having received breast cancer treatment (i.e. surgery and possible adjuvant chemo and/or radiotherapy) at least 18 months before the start of the study.
* self reported pain in the areas of the breast, shoulder, axilla, arm and/or side of body with an intensity of ≥ 3 on a numeric rating scale (0 = no pain, 10 = worst pain imaginable).
* no signs of cancer recurrence.
* reading, writing and speaking Danish.

Exclusion Criteria:

* breast surgery for cosmetic reasons or prophylactic mastectomy.
* bilateral breast cancer.
* lymphedema.
* other chronic pain conditions (e.g., rheumatoid arthritis).
* previous diagnosis of fibromyalgia syndrome.
Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)

The main goal of this study is to tests the effect of incentivizing achievement of self-identified, personal harm reduction goals (Contingency management or CM) compared with standard of care (peer harm reduction service with incentives for peer visits) to increase the reach and effectiveness of methamphetamine (MA) harm reduction services.

Using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design, this study will randomize eighteen community-based peer harm reduction sites to provide contingency management incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g. completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals) versus standard of care contingency management (i.e. incentives for peer encounter attendance).

Eligibility Criteria:
Inclusion Criteria:

This intervention is at the site level. Community-based organization sites are eligible if they:

* Use peer support specialists to provide direct outreach and harm reduction services to people who use drugs
* Are willing to be trained in the two strategies for peer-facilitated contingency management

Clients who:

* Age 18 and older
* Any stimulant (methamphetamine, cocaine) use in the past 30 days
* Willing to accept peer services
* Willing to complete initial and follow-up assessments with peer
* Able to communicate in English or Spanish

Exclusion Criteria:

Community-based organization sites who:

* Do not use peer support specialists to provide direct outreach and harm reduction services to people who use drugs
* Are not willing to be trained in the two strategies for peer-facilitated contingency management

Clients who:

• Present any danger or threat of violence to peers
Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment

This K23 study is an effectiveness-implementation hybrid type I design to determine the effectiveness of Motivational Interviewing at Intake (MII), relative to intake-as-usual on client engagement and mechanisms of engagement among adults seeking outpatient addiction treatment. We also will obtain personnel feedback on the feasibility of implementing MII into standard practice by having personnel from the addiction treatment study sites complete implementation climate measures before Motivational Interviewing (MI) training and post-clinical trial, as well as an individual interview on implementation feasibility post-trial.


Eligibility Criteria:
Inclusion Criteria (client participants):

* English-speaking adults seeking treatment for alcohol or other drug use at one of two outpatient addiction treatment programs
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures
* Physically withdrawn from alcohol or other drugs

Inclusion Criteria (personnel participants):

* English-speaking adults currently employed at one of the two outpatient addiction treatment programs
* Provision of electronic informed consent

Exclusion Criteria (client participants):

* Experiencing severe withdrawal symptoms
* Actively psychotic, manic, and/or suicidal

Exclusion Criteria (personnel participants):

* current position: facility owner or clinical director
Study of Genes and the Environment in Patients With Colorectal Cancer in the East Anglia Region of the United Kingdom

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

PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with colorectal cancer.

OBJECTIVES:

* To obtain epidemiological information and biological material on a population based series of colorectal cancer cases.
* To define the proportion of colorectal cancer incidence attributable to mutations in known predisposing genes such as MLH1 and MSH2.
* To establish whether mutations at other loci may predispose to colorectal cancer, by comparing the frequency of alteration candidate genes in colorectal cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.

OUTLINE: This is a multicenter study.

Patients complete an epidemiological questionnaire. The questionnaire also requests identifying information about the patient's first-degree relatives.

Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the colorectal cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain, and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colorectal cancer within the past 5 years
* Identified in the East Anglia region of the United Kingdom

PATIENT CHARACTERISTICS:

* Identified by the patient's general practitioner as fit to contact for this study
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified
Soberlink Within In-Home Addiction Treatment Program

The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.

The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between ages of 21-75 years old
* Subject active in In-Home Addiction Treatment Program (Aware Recovery Care)
* Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5
* Primary or secondary diagnosis is alcohol use disorder
* Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC)
* Subject is willing to discuss Soberlink test results with Care Team
* Subject is willing to sign Soberlink Client Agreement
* Subject is English speaking and reading

Exclusion Criteria:

* Alcohol use disorder is not a primary or secondary diagnosis
* Subject is not between ages of 21 and 75 years old
* Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol)
* Subject will not be in the United States through duration of study
* Subject is unwilling to properly use the device
* Subject is non-English speaking and reading
* Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder involving depersonalization or active psychotic symptoms
* Active withdrawal/alcohol use within 72 hours of start of participation
* Subject is using Soberlink data for a child custody or legal consequence
Vitamin D Status and Muscle Function

People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. In light of this, the investigators want to examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength.

To examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24 years) residing at latitude 55-56°N were included to the trial conducted in March-April. Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were assessed by food frequency questionnaire and sun exposure and training status by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

Age: 16-35 years

Top atlets, conducting:

* Hard physical activity
* Indoor elitesport min. 10 hours a week
* Healthy, without use of any medications
* Eat fish max 2 times per week

Exclusion Criteria:

* Use of corticosteroids
* Illness
* Use of supplements
* Use of solarium
* Donation of blood within the last 3 months
* Having spent time below the latitude of 42° north from September through April
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.


Eligibility Criteria:
Inclusion Criteria:

* Currently being treated for ADHD

Exclusion Criteria:

* Other psychiatric diagnoses
* Significant cognitive impairment
* Chronic medical illnesses
* Structural cardiac defects
* Significant abnormal lab tests
* Taking disallowed medications
* Positive drug test
A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
* At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors \[RECIST\].
* Adequate bone marrow, liver function and renal function as defined by protocol.
* Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.

During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

Exclusion Criteria:

* Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
* Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
* Patients with carcinomatous meningitis or un-treated brain metastases.
* Any acute cardiovascular incident within the past 12 months.
* Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
* Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.
Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.


Eligibility Criteria:
Inclusion Criteria:

* Module 1: Locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (that is \[i.e.\] participants who have exhausted all standard of care options according to International Guidelines), which may convey clinical benefit from the combination treatment with M9466 and carboplatin and have not received more than 3 lines of prior anticancer therapy in the advanced/metastatic setting Module 2: Histologically or cytologically confirmed treatment-naïve, de novo, extensive stage small cell lung cancer (ES-SCLC), who have no history of systemic treatment for the disease. Participant must be considered suitable to receive carboplatin, etoposide, and atezolizumab as first-line treatment for ES-SCLC
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (\<=) 1 (ECOG PS 2 eligible if considered related to SCLC tumor load in Module 2)
* Have adequate hematological, hepatic, and renal function as defined in the protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Module 1: Persistence of AEs related to any prior treatments that have not recovered to Grade \<= 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 unless AEs are clinically non-significant and /or stable on supportive therapy in the opinion of the Investigator (for example \[e.g.\] neuropathy or alopecia)
* Module 2: Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except if clinically controlled, which is defined as individuals with CNS tumors that are asymptomatic and who do not require steroids for the treatment of CNS tumors
* Life expectancy of less than (\<) 3 months
* Other protocol defined exclusion criteria could apply
Doripenem in the Treatment of Ventilator-Associated Pneumonia

The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consists of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit. The patients will receive either doripenem or comparator for 7 to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient has received mechanical ventilation for \> 24 hours
* Presence of a new or progressive infiltrate on chest x-ray

Exclusion Criteria:

* Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics
* History of moderate or severe hypersensitivity reactions to certain antibiotics
Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine

The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.


Eligibility Criteria:
Inclusion Criteria:

* age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999

Exclusion Criteria:

* patients seeking any periodontal treatment during the course of study
Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by ultrasound detection of microbubble contrast agents that behave in the circulation similar to red blood cells. In this study, the investigators hypothesize that contrast ultrasound of blood flow in the leg (thigh and calf) at rest and during stress produced by medications that mimic exercise (vasodilator stress) can provide information on the location and severity of peripheral vascular disease (blockages of the blood vessels in the leg). The investigators will also determine whether symptom improvement after revascularization (procedures to open up or bypass the blockages) is directly related to the improvement in blood flow.


Eligibility Criteria:
Inclusion Criteria:

1. Known or suspected PAD
2. Lower extremity angiography or MRA planned or performed within 6 months

Exclusion Criteria:

1. Age \<19 y.o.
2. Pregnant or lactating females
3. Hypersensitivity to ultrasound contrast agent, dipyridamole, or regadenoson
4. Severe reactive airways disease
5. Evidence right-to-left shunt (identified on screening echo)
6. NYHA Class III or IV heart failure.
7. Planned amputation
8. Unstable coronary artery disease or severe aortic stenosis
The STOP-HPV Trial 4: Bundle Intervention

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of HPV vaccine communication, performance feedback reports and provider prompts (the bundle) to reduce MOs and increase HPV vaccination rates.

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of a bundled intervention training providers first in HPV vaccine communication skills (done through online educational modules and live office practice sessions), with the addition of performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) followed by the addition of provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.

Eligibility Criteria:
Practice Inclusion Criteria:

* The practice provides HPV vaccination services to adolescents.
* The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
* The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
* The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

* The practice plans to change EHR systems in the next three years.
* The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
* Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).