cyrilzakka/clinical-trials huggingface dataset:
Hospital-Based Contingency Management

This study aims to adapt an outpatient mobile app-based contingency management intervention to the hospital setting to understand how we can use contingency management to improve health outcomes in hospitalized patients with stimulant use disorders.

Contingency management (CM), an evidence-based strategy that utilizes a reward-based system as positive reinforcement, has been most robustly studied in the outpatient setting, but also has the potential to improve hospital care for patients with stimulant use disorder. The hospital is a challenging environment for people who use drugs. Conflicts with staff often result from in-hospital substance use, prolonged time off the unit, and missing medications, leading to negative health outcomes and re-admissions. By relying on positive rewards to encourage positive health behaviors, CM has the potential to improve staff-patient relationships, healthcare engagement, and reduce substance use in the hospital. Stimulant use disorder is especially difficult to address in the hospital due to a lack of medications that can support cravings and withdrawal symptoms. However, little is known about CM implementation in hospitals and the hospital setting may introduce unique challenges.

The objective of this study is to adapt an outpatient mobile app-based CM intervention to the hospital setting to understand the feasibility and acceptability of a hospital-based CM intervention to improve health outcomes in hospitalized patients with substance use disorders. We'll achieve this objective through following specific aims: Aim 1: Identify adaptations needed to implement an evidence-based outpatient mobile-app based CM intervention to the hospital setting for hospitalized patients with substance use disorders. Aim 2: Determine the feasibility, including facilitators and barriers, of implementing a mobile app-based CM intervention in the hospital setting. Aim 3: Assess the acceptability of a mobile app-based hospital-based CM intervention to patients and staff.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Have moderate to severe stimulant use disorder, as diagnosed using DSM-5 criteria for stimulant use disorder by an addiction medicine provider
* Have an anticipated hospital length of stay greater than 2 weeks
* Be able to use a smartphone and agree to download and use the Affect app as part of study-related procedures
* Be English speaking and be able to understand explanations of study procedures and the informed consent to participate

Exclusion Criteria:

* Unable to engage in the intervention due to cognitive impairment or altered mental status
* Unable to engage in the intervention due to acute medical/mental health issues, per judgement of the research assistant
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings.

This clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy device.The clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of Ewata balloon guide catheter in combination with a stent for thrombectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke
2. within 8 hours
3. Patients aged 18-80 years (including critical point)
4. NIHSS score 4-30 (including critical points)
5. Pre-onset mRS score \<2
6. Large vessel lesions were detected by head CT, CTA, MRI, MRA, or DSA
7. The patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (IBC).

Exclusion Criteria:

1. Head CT exclusion criteria (exclusion if any of the following conditions are met)
2. Cerebral hemorrhage
3. Intracranial tumors, except for small meningiomas
4. Large area of early cerebral infarction (low density shadow \>1/3 cerebral hemisphere)

Clinical and laboratory exclusion criteria

1. seizure
2. Symptoms of nervous system loss improved rapidly
3. Severe stroke (NIHSS≥31 points) or mild stroke (NIHSS≤3 points)
4. CT examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms
5. A history of intracranial hemorrhage and subarachnoid hemorrhage
6. A history of cranial trauma in the last 3 months
7. A history of cerebral or myocardial infarction in the last 3 months
8. A history of gastrointestinal or urinary tract bleeding in the last 3 weeks
9. A history of major surgery in the last 2 weeks
10. A history of arterial puncture in the last l weeks that was difficult to stop bleeding
11. Patients with severe cardiac, hepatic or renal insufficiency (\>250 mol/L) or severe diabetes mellitus
12. Physical examination revealed evidence of active bleeding or trauma, such as a fracture
13. Oral anticoagulants have been taken, and INR\>1.7
14. Blood glucose \<2.7 mmol/L or \>22.2 mmol/L
15. Systolic blood pressure \>185 mmHg, or diastolic blood pressure \>110 mmHg Pregnancy
16. There is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /L
17. Systemic infection without control or local infection of puncture point Hypersensitivity to contrast media
Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis

The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
* Age between 18 and 80 years old

Exclusion Criteria:

* pregnant woman and satisfying women
* cancer, chronic infections, autoimmune diseases
* gastrointestinal illnesses
* liver diseases
* renal malfunctions
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches

Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.

The purpose of this study is to determine whether individuals with cervicogenic headache respond favorably to a program of manual therapy in combination with dry needling of the major muscle between chest bone and the head (sternocleidomastoid muscle) compared to manual therapy directed to the upper body quadrant alone.

The researchers will conduct a randomized clinical trial to assess the effectiveness of a manual therapy and dry needling approach (group 1) vs. manual therapy only. (group 2)

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-65 years old
2. Primary complaint of cervicogenic headache
3. Restricted cervical Range of motion
4. Neck Disability Index \> 20 points

Exclusion Criteria:

1. Red flags identified during the patients physical therapy initial evaluation (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
2. Use of blood thinners
3. History of whiplash injury within the past six weeks
4. Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Muscle weakness involving a major muscle group of the upper extremity
   2. Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
   3. Diminished or absent sensation to pinprick in any upper extremity dermatome
6. Prior surgery to the neck or thoracic spine
7. Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 6-months
8. Workers compensation or pending legal action regarding their headaches
9. Insufficient English language skills to complete all questionnaires
10. Inability to comply with treatment and follow-up schedule
Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass

The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery.

Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Primary metabolic procedure;
* Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass;
* ≥18 years;
* Good command of the Dutch or English language.

Exclusion Criteria:

* Patients unwilling to give informed consent;
* Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT));
* Patients who use anticoagulants;
* Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.

Hypotheses:

1. Secretion of endogenous insulin depends on exogenous insulin supply
2. Secretion of endogenous insulin is depends on plasma glucose levels

There are a screening visit and two treatment sessions:

Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Insulin-naive patients
* HbA1C \< 9%
* Women and men \>= 35 and \<= 75 years old
* BMI 25-42 kg/m2, both values are included

Exclusion Criteria:

* Suspected or known allergy to the trial drug or similar medications
* Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
* Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
* Severe uncontrolled hypertension with blood pressure in lying position \> 180/110 mmHg
* Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
* Impaired kidney function with eGFR \< 50 ml/min according to the local laboratory
* Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
Validation and Implementation Design of an Epic Systems 30-day Unplanned Readmission Risk Model

The objective is to assess the implementation of a computerized clinical decision support (cCDS) tool for identifying patients at high risk of unplanned readmission who could benefit from existing care programs aimed at reducing readmissions

Providers from either service, which includes attending physicians, residents, hospitalists, and advanced practice providers (APPs), will be randomly allocated to an intervention group (IG) or control group (CG). The IG will consist of placing the Epic 30-day unplanned readmission risk score in the story board of providers. If a patient is identified as having a high risk of readmission defined as readmission risk \>20%, a link to transitional and supportive care services (TSC) will be appear in the story board. Providers will determine which TSC is best for the patient and may order whichever TSC is appropriate for the patient. The study team will not recommend TSCs. The risk of readmission score will be present from the time of admission for those in the IG. The CG will have the same TSC orders available to them; however, they will not have the risk of readmission score present in their workflow, as such the embedded link to TSC will also not be present.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Atrium Health Wake Forest Baptist Hospital (AHWFBH)
* 18 years or older
* meeting inpatient criteria
* admitted to hospitalist or general medicine teaching services
* Providers on the hospitalist or general medicine teaching services

Exclusion Criteria:

* Psychiatric diagnoses during index or subsequent admission
* left Against Medical Advice (AMA)
* planned readmission
* died during index admission
* Providers who opt out of the study
Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI

Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks

Despite the application of compression stockings looks simple, it must be remembered that inappropriately worn stockings have the potential to cause certain problems. Unevenly distributed and excess pressure may break the skin, especially in older, malnourished patients and those with thin, brittle skin.

Although an extreme case, it highlights the importance of careful assessment, application, and monitoring of compression stockings.

Typically, the stockings are safe and wearing them results in few or no complications, provided they're worn smoothly against the leg, without any folds. But some groups of people should avoid them, including those with peripheral neuropathy or any other condition that impacts skin sensation; a history of a peripheral arterial bypass grafting; peripheral artery disease; skin infection; dermatitis with oozing or fragile skin; massive leg swelling; or pulmonary edema from congestive heart failure. Each of these conditions presents a different series of risks. For example, for people with peripheral artery disease, stockings can worsen oxygen delivery in arteries with impaired blood flow. People who have sensory problems, such as those with peripheral neuropathy, may not feel when a compression stocking is too tight, which could impede circulation. And certain skin conditions or infections may worsen with a compression stocking covering and pressing on the area.

In general, if subject has any medical condition, he/she should talk with health care professional before using compression stockings to see if they are good candidate for them.

Since probability of side/adverse effects from IP use is considered as very low vs of high probability of expected positive effects.

Study Purpose and Design Multi-center, observational open label study aimed to evaluate an impact on quality of life in Chronic Venous Insufficiency patients using SANKOM® Patent Socks during 4 weeks

This study will involve a maximum of 30 subjects. Subjects will be followed through outpatient's observation.

Primary Objective

Improvement of QoL by scores of:

* Aberdeen Varicose Veins Questionnaire (AVVQ)
* CIVIQ-2 Venous Quality of Life Questionnaire

Secondary Objectives

Secondary Endpoints are:

* Improvement of US-examination picture
* Improvement of QoL by Subject's questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent before any procedure;
2. Subject is male or female, 35-65 years of age;
3. Subject with chronic venous insufficiency CEAP (C1, C2);
4. Subject can speak and understand Ukrainian or Russian language.

Exclusion Criteria:

1. Subject participated in any clinical study (drug or device) within 6 months prior to the screening;
2. Subject unable to wear compression stockings;
3. Subject using other compression therapy.
A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months.
* Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including:

  * Autologous HSCT, unless the subject was ineligible
  * A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination
  * Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy.
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Known active or history of central nervous system (CNS) involvement of MM
* Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
* Active autoimmune disease requiring immunosuppressive therapy
* History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis

Other protocol-defined inclusion/exclusion criteria apply.
Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.

EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).

Eligibility Criteria:
Inclusion Criteria:

* Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.
* Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2.
* HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications.
* If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study.
* Female subjects must be surgically sterilized or postmenopausal.
* Non-smoker for at least 3 months.
* Negative alcohol screen.

Exclusion Criteria:

* Type 1 diabetes.
* Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea.
* Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening.
* Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
* Previous treatment with EGT0001474.
* Vaccination within 30 days prior to the first dose of study medication.
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.

OBJECTIVES:

* Determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors.
* Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age, gender, race, and educational background. All patients complete a Hot Flash Daily Diary to record frequency and severity of hot flashes for 1 week. Patients are then randomized to 1 of 2 treatment arms.

* Arm I (hypnotherapy): Patients undergo hypnotherapy once a week for 5 weeks. Patients complete the Hot Flash-Related Daily Interference Scale, the Hospital Depression and Anxiety Sub-scale, the CES Depression Scale, and the MOS-Sleep and Sexual Function Scales in week 5 after the last hypnotherapy intervention. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.
* Arm II (control): Patients receive no contact for 4 weeks. Patients complete the questionnaires as in arm I in week 5. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* History of primary breast cancer

  * No evidence of detectable disease
* At least 14 hot flashes per week for ≥ 1 month by self-reporting
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Life expectancy \> 6 months
* Menopausal status not specified
* Outpatient status
* No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

* Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month
* No other concurrent hormonal therapy
* No other putative therapies for hot flashes ≥ 1 month prior to study entry

  * Concurrent vitamin E allowed
* No other concurrent treatment for hot flashes
* No concurrent cytotoxic chemotherapy
* Not concurrently using hypnosis for any reason