cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics. The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting. The intervention will be implemented within primary care clinics in two managed care organizations (MCOs). The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the Patient-focused Intervention

* Average risk
* Male or female
* 50-75 years
* Scheduled for non-acute ambulatory care visit at one of the study sites
* Due for CRC screening including no record of FOBT in the past year, no record of flexible sigmoidoscopy in the past 5 years, no record of colonoscopy in the past 10 years, and no record of double contrast barium enema in the past 5 years

Inclusion Criteria for the Clinic-focused Intervention

* Primary care clinicians, to include the following specialties: Family Practice/General Practice Physicians, General Internal Medicine Physicians, Nurse Practitioners in Family/General Practice, Physician Assistants who conduct non-acute ambulatory medical exams in study clinics
* Primary care clinical staff, to include nurses, medical assistants, and appointment schedulers

Exclusion Criteria (Patients):

* Prior diagnosis of CRC
* Prior diagnosis of colorectal polyps
* Prior diagnosis of ulcerative colitis
* Prior diagnosis of Crohn's Disease
* Prior diagnosis of hereditary nonpolyposis or polyposis
* Medical records contain an International Classification of Diseases (ICD-9) code for family history of CRC
* Younger than 50 years of age
* Older than 80 years of age.
Emotion Regulation and Cancer Caregiving

The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.


Eligibility Criteria:
Inclusion Criteria:

All participants must:

* Be 21 years or older
* Have access to a computer with internet access

Patients must:

* Be women
* Have a diagnosis of breast cancer (non-recurrent)

Caregivers must be:

-The patient's caregiver (providing support to the patient)

Exclusion Criteria:

Participants must not be:

-Younger than 21 years

Patients must not:

* Be men
* Have a diagnosis other than breast cancer (non-recurrent)
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female aged 18 to 75 years, inclusive.
* Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points

Exclusion Criteria:

* Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
* Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
Omission of SLNB in CN0 Early Breast Cancer

The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \[18F\]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged 18-70 years;
2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
3. Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
4. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
5. Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
6. ECOG score 0-1;
7. Patients volunteered for this study and signed the informed consent form.

Exclusion Criteria:

1. Bilateral/lactating/pregnant breast cancer;
2. Previous history of malignant tumor or neoplasm;
3. Clinical or imaging confirmation of distant metastasis;
4. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
5. Prior history of radiotherapy to the breast or chest;
6. Positive pathological margins after breast-conserving surgery or mastectomy;
7. Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
8. Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) \< 50% on cardiac ultrasound;
9. Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
10. No personal freedom and independent civil capacity;
11. Presence of mental disorders, addictions, etc;
12. Not eligible for enrollmentas as judged by the investigator.
NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus
* Other types of diabetes mellitus (gestational, drug induced \[thiazide\] or metabolic syndrome-related)
HOBSCOTCH for People With Post Acute COVID-19 Syndrome (PACS)

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Post Acute Covid Syndrome (PACS).

The main questions it aims to answer are:

Can the current HOBSCOTCH program be adapted for people with PACS?

Will people with PACS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PACS sessions with a one-on-one certified HOBSCOTCH-PACS coach
* complete a brief clinical questionnaire about their diagnosis of PACS
* complete seven questionnaires before and after the HOBSCOTCH-PACS sessions about their quality of life, memory and thinking processes (objective and subjective cognition), about their physical and mental health and about autonomic symptoms associated with their diagnosis of PACS
* keep a short daily diary (using a smart phone app or on paper) about their PACS symptoms and use of the self-management strategies taught in the HOBSCOTCH-PACS program
* complete two brief surveys to assess satisfaction with their experience after the entire HOBSCOTCH-PACS program


Eligibility Criteria:
Inclusion Criteria:

* Literate, English-speaking with grade 12 or equivalent in education
* Self-reported diagnosis of PACS
* Self-reported cognitive/memory difficulties
* Telephone and internet access

Exclusion Criteria:

* Cognitive dysfunction that precludes participation in giving informed consent
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* Neurodegenerative illness (i.e. dementia)
* Acute psychiatric disease
Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Prospective randomized control pilot study

The primary aims of this investigator initiated study is :

Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.

Eligibility Criteria:
Inclusion Criteria:

* Normal Left Ventricular systolic function
* Frequent PVCs

Exclusion Criteria:

* Current use of any (I and/or III) antiarrhythmic medication
* Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
* Complete Atrioventricular block and pacemaker dependent
* Ongoing uncontrolled hypertension with systolic Blood Pressure\> 180
* Family history of dilated Cardiomyopathy in a first degree relative
* Alcohol use disorder or illicit drug use
* Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response
* Moderate to severe valve disorders
* Patient with shortwave/microwave therapy equipment
Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4

The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested."

16-week participation plus a 2 weekk lead-in period. Participants are assigned randomly to placebo or amantadine. Participants attend group meeting 3 times/week

Eligibility Criteria:
Inclusion Criteria:

M/F, ages 18-65. cocaine dependence according to DMS-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer

Sarcopenia is defined by the reduction in skeletal muscle mass and physical performance. It results in a decrease in muscle strength, overall physical activity, walking and the development of balance disorders and falls. It is one of the natural consequences of aging and contributes to frailty and the appearance of geriatric syndrome (s) (Chandapasirt et al, 2015; Cruz-Jentoft et al, 2010).

Its prevalence in patients with Head \& Neck cancer is 39% (Hua et al, 2020) and is associated with an increase in postoperative complications (Achim et al, 2017; Bril et al, 2019), with greater toxicity of chemotherapy. (Wendrich et al, 2017) and reduced overall survival (Hua et al, 2020).

It is measured by CT scan (assessment of muscle volume with respect to L3 using IMAGE J software) (Teigen et al, 2018) and by clinical tests (performance tests) (Swartz et al, 2016, Cruz-Jentoft et al, 2010).

Several studies have shown a possible assessment of sarcopenia by measuring skeletal muscle mass with regard to C3 (Ufuk et al, 2019; Swartz et al, 2016).

This trial aims to evaluate the prevalence of sarcopenia in head and neck cancer evaluated by CT at C3.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years old,
* affiliated to the social security scheme,
* suffering from locally advanced head \& neck cancer (stages I to IVB) at diagnosis,
* not operable,
* justifying treatment by radiotherapy, whether or not associated with chemotherapy or targeted therapy (eg: monoclonal antibodies, immunotherapy) whatever the proposed modalities.

Exclusion Criteria:

* patient treated by non-conservative surgery and cervical lymph node dissection making it impossible to assess muscle mass with regard to C3,
* metastatic disease,
* minor patient,
* adult patient under guardianship,
* pregnancy or breastfeeding in progress.
Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma

The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma

Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of apoptosis and cell-cycle redistribution.

The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy.

Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections.

Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV
* Bidimensionally measurable disease
* Performance status Zubrod 0-2
* Less than 20,000/mcL circulating lymphoid cells on WBC differential count
* No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
* Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by echocardiogram
* Fertile patients with effective contraception method
* No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of cervix
* No HIV positive, no prior solid organ transplantation
* No prior antibody therapy, chemotherapy, radiotherapy for lymphoma

Exclusion Criteria:

* Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma
* Active uncontrolled infection
* Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
* Patients with more than 25% infiltrated bone marrow
* Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.

Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.

Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.

The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis

Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease
* Ages 3 years - 21 years

Exclusion Criteria for Enrollment:

* Pregnancy
* Known allergy to Fentanyl
* Usage of daily home opiates

Exclusion Criteria at presentation in ED with a painful crisis:

* Wong Baker FACES Pain Score \<6
* Systolic blood pressure \< 5 percentile for age
* Oxygen saturation \<92% on room air
* Temperature \> 102°F
* Respiratory distress
* Priapism
* Isolated abdominal pain
* Isolated headache
* New neurological symptoms
* Severe rhinorrhea or epistaxis
* History of trauma
* Pregnancy
Selective Effect of Foam Rolling and Manual Massage

The present double-blinded randomized controlled design aims at comparing the effects of a full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were randomly allocated to foam rolling, manual massage or a control intervention consisting in an autogenic relaxation routine.

Self-report ratings of perceived anxiety, muscle pain and relaxation were the psychometric outcome variables. Sit-and-reach, toes-touch and mental calculation performances were the behavioral variables. Resting-state alpha and beta power recorded using electroencephalography and galvanic skin resistance measures were the neurophysiological outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)

Exclusion Criteria:

* Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception
Use of the SWAMECO Questionnaire Basel

A patient self-report questionnaire was developed that assesses subjective swallowing difficulties with medication intake, the SWAMECO questionnaire. It was validated in a highly specific population and will now be tested in the general population.

Based on a systematic literature review, a novel self-report questionnaire was developed in 2016 to assess subjective swallowing difficulties with medication intake and their practical consequences in ambulatory patients, the SWAMECO questionnaire. It consists of 30 items divided into 5 sections Complaints, Intensity, Localization, Coping strategies, and Adherence to medication. It was validated in people suffering from systemic sclerosis (SSc), a rare multisystem autoimmune disease that often leads to swallowing problems with food and liquids with progression. The aim of this study is now to validate the questionnaire in the general population. Patients presenting in the community pharmacy with a prescription of at least 3 different medications for a minimum of 3 months will fill in the questionnaire on site.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more
* is living in the community setting
* is receiving three or more medications for a period not less than three months, independently of the frequency of the intake

Exclusion Criteria:

* patients who are not able to provide written conformed consent will be excluded
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects

The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Receipt or treatment with an investigational or marketed biologic drug.
* blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
Warm Water and Unsedated Colonoscopy

Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 85 Years
* adult patients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent
Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity

We aim to examine, whether hospitalization is associated with higher high-sensitivity cardiac troponin T (hs-cTnT) serum concentrations in patients without a cardiac disease.

High-sensitivity cardiac troponin T (hs-cTnT) values will be obtained in hospitalized patients a) without a diagnosed or suspected cardiac disease, and b) with an acute medical condition that is not commonly associated with an increase of hs-cTnT concentrations. As a reference, a second sampling of blood for an analysis of the hs-cTnT serum concentration will be obtained in the same patients after discharge (60 days after hospitalization).

Eligibility Criteria:
Inclusion Criteria:

* hospitalization due to a non-cardiac disease
* age ≥ 50 years

Exclusion Criteria:

* diagnosed or suspected cardiac disease
* acute medical conditions commonly associated with a myocardial injury (e.g. circulatory shock, sepsis, pulmonary embolism, cerebral infarction, acute renal failure)