cyrilzakka/clinical-trials huggingface dataset:
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.

PRIMARY OBJECTIVES:

I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.

II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.

III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.

OUTLINE:

Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.

After completion of study, participants are followed up at days 14, 30, 80-110, and 170-200, and at 11-14 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be included are those with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk.
* Patients with clinical stage 0-IIIC will be included.
* Any performance status and any life expectancy.
* The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.
* Prior therapy will not be used as a limitation in this study.

Exclusion Criteria:

* Patients will be excluded if they are not candidates for surgery
* Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Analgesic Effects of Midazolam in Human Volunteers

This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.


Eligibility Criteria:
Inclusion Criteria:

* male and female volunteers
* 18-40 years old
* healthy
* body mass index between 5th and 85th percentile
* Caucasian
* non smoker or moderate smoker (\<10 cigarettes per day)
* able to understand, write, and read German

Exclusion Criteria:

* acute or chronic pain condition (except for mild day-to-day pain on \<5 days/month)
* previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
* symptoms of a clinically relevant illness in the 2 weeks before the first study day
* hypertension
* any known psychiatric condition
* abuse of alcoholic beverages, drug abuse
* known positive human immunodeficiency virus status
* any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
* participation in a clinical trial in the 4 weeks preceding the study
* known allergy against Midazolam
* known allergy against Fentanyl
* pregnancy or breast-feeding
* unable or unwilling to give informed consent
* unable or unwilling to follow investigator's instructions
* unable or unwilling to comply with study protocol
Shoulder Corticosteroid Injection in Diabetic Patients

In type 2 diabetic patients affected by chronic shoulder pain, subacromial injection with corticosteroid could be an effective treatment. The aim of this study was to measure the risk-benefit ratio of this treatment.Twenty patients with well-controlled diabetes were included in a prospective study. In a first pre-injection phase, patients were asked to measure glycemia for 7 days, before breakfast and dinner, then 2 hours after lunch and dinner. Baseline data including Constant Score (CS), Subjective Shoulder Value (SSV) and Numerical Rating Scale (NRS) for pain were collected. Patients were treated with subacromial injection with 40mg of Methylprednisolone Acetate and 2ml of Lidocaine. At discharge, patients were asked to re-measured glycemia for the following week.


Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study.
* Severe overall pain and night pain: Numerical Rating Scale (NRS) for pain\[8\] above or equal to 60/100; the scale was modified from 0-10 to 0-100 (0 = no pain 100 = unbearable pain).
* No significant improvement after at least 2 courses of physiotherapy (including direct assistance from a physical therapist with specific exercises, manual therapy, and physical agents in order to reduce inflammation and pain).
* Clinical signs of subacromial tendinobursitis, with or without signs of rotator cuff tear, defined as positive Neer, Yocum and Hawkins tests\[9-15\]. Pain experienced during the execution of these tests needed to reproduce the type of pain that patients complained the most.
* No indication for surgery due to the age, concomitant comorbidities or patient's refusal to undergo surgery.
* Well-controlled type-2 diabetes, defined as:

  * Fasting and pre-prandial blood glucose levels in the range of 90- 150mg/dL.
  * Hb1Ac \<64mmol/mol (corresponding to 8%) measured within 6 months.
* A device for self-measurement of blood sugar levels at home
* Patients need to have a recent (within 6 months) x-ray and an MRI or ultrasound of the affected shoulder

Exclusion Criteria:

* Corticosteroid treatment in the past 3 months.
* Complaints of shoulder stiffness more than shoulder pain.
* Symptomatic glenohumeral arthritis defined as shoulder stiffness plus moderate radiographic signs of arthritis (grade \>2 according to Hamada classification and grade \>1 according to Samilson-Prieto classification for eccentric and concentric arthritis respectively).
* Shoulder trauma within 3 months of inclusion evaluation for in this study.
* High blood pressure values (systolic blood pressure \>140mmHg, diastolic blood pressure \>80mmHg).
* Glaucoma.
Electronic Decision Support Systems for Smokers With Severe Mental Illness

This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.

Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments.

One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool.

Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone.

Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.

Eligibility Criteria:
Inclusion Criteria:

* adult age 18-75
* in treatment for severe mental illness,
* current smoker,
* physically able to use a computer

Exclusion Criteria:

* Using smoking cessation treatment in past month,
* substance dependence with current use
Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects

Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema

Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )

Exclusion Criteria:

* history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
* an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
* systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
* major surgery within the prior 6 months or planned within the next 28 days
Short Message Service Based Patient Education in Spine Patients

The investigators primary objective is to evaluate whether an SMS based patient education program improves patient satisfaction.

Back and neck related complaints effect as much as 11% of the U.S. population and are one of the most common presenting complaints at health care visits. A small subset of these patients receive spine surgery of various types in the hopes of alleviating symptoms that are recalcitrant to conservative management. The utilization of spine surgery has been rapidly increasing.2 An estimated 413,000 spinal fusions were performed in the U.S. in 2008 accounting for almost $34 billion in charges.

Patient satisfaction has become an increasingly important measure of healthcare quality. This paradigm shift is evident in the changing reimbursement models used by the Centers for Medicare and Medicaid Services (CMS). Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a survey-based assessment of patient satisfaction that was initially developed in 2002. Currently, HCAHPS provides the ability to compare patient satisfaction with the care they receive at various healthcare systems across the country. These scores are used as part of a value-based purchasing initiative that can lead to a hospital gaining or losing as much as 1.5% of their annual medicare revenue as a result of patient satisfaction based incentives. This presents an important opportunity to optimize patient satisfaction in order to both improve patient care and preserve hospital income.

A number of novel text-message based applications have been developed for healthcare use in various settings. In the surgical setting text messaging has been used to provide pre-operative education modules, as well as to track medication adherence after transplant. This study aims to develop and critically evaluate, a text-messaging based patient education system aimed at improving patient satisfaction with the post-operative course after spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and over undergoing spine surgery at the University of Utah

Exclusion Criteria:

* Patients under 18 years of age.
Wrist Position Sense in Individuals With Multiple Sclerosis

No study has been found examining the effect of wrist position sense on manual dexterity in individuals with multiple sclerosis.The purpose of this study is to examine the effect of wrist position sense on manual dexterity of the hand.

Multiple sclerosis is a chronic demyelinating disease of the central nervous system that occurs in young adults and usually progresses with attacks and remissions. As the disease progresses, symptoms such as fatigue, muscle weakness, loss of balance, loss of sensation, spasticity, visual disturbances and bladder dysfunction are observed. In addition to these symptoms, hand functions may be affected even in the early stages of the disease.

Appropriate motor control and mobility skills are required to perform manual dexterity effectively. Joint stabilization and perception of the joint's position and movement in space are needed for motor control of hand functions. In this process, position sense signals contribute significantly to the target localization and performance of the hand. Position sense signals must be constantly updated for the coordination and integration of hand position during manual activities such as holding or grasping an object. This is possible with a healthy sense of position.

Although it is known that position sense is affected in MS patients, no study has been found examining the effect of wrist position sense on manual dexterity. The purpose of this study is to examine the effect of wrist position sense on hand dexterity. Patients' manual dexterity will be evaluated using the Purdue Pegboard Test, and wrist position sense will be evaluated using the K-FORCE Sens® electrogoniometer.

Eligibility Criteria:
Inclusion Criteria:

* Patient group:

  * Disability score (EDSS: Expanded Disability Status Scale) should be between 0-3.
  * Being between the ages of 18-50
  * Not having had an attack in the last 3 months
  * Scoring 24 points or above on the Mini-Mental State Examination
  * Patients diagnosed with relapsing-remitting MS with a disease duration of at least 2 years
  * Patients without spasticity according to MAS

Control group:

* Volunteers in a similar age range who agreed to participate in the study
* Being between the ages of 18-50

Exclusion Criteria:

* Patient group:

  * Presence of diagnosed visual impairment
  * Having other chronic diseases not related to MS
  * Having any orthopedic, neurological, rheumatological or metabolic diagnosis that causes upper extremity involvement
  * History of hand and upper extremity disorders, peripheral nerve disorders, and medical or psychiatric disorders that may significantly affect cognitive function
  * Presence of wrist joint range of motion limitation

Control group:

* Having any orthopedic, neurological, rheumatological or metabolic diagnosis that causes upper extremity involvement
* History of hand and upper extremity disorders, peripheral nerve disorders, and medical or psychiatric disorders that may significantly affect cognitive function
* Presence of wrist joint range of motion limitation
Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis

The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic documentation of breast cancer.
2. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
3. Age \> 18
4. Written informed consent prior to study entry
5. Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
6. Life expectancy of at least 6 months.
7. We will include patients who have had previous or current radiation therapy to breast

Exclusion Criteria:

1. Concurrent malignancy with a second primary
2. Stage I, Stage II and Stage III
3. ECOG Performance Status 3 or 4.
4. Renal Failure - serum creatinine \>2.O mg/dL at screening
5. AST or ALT \> ULN X 3. at screening
6. Bilirubin \> 3.0 mg/dL at screening
7. Pregnant women
8. Prior or current bisphosphonate therapy
9. Any skeletal related event due to malignancy prior to study enrollment.
10. Patients with osteoporotic fractures prior to study enrollment.
11. Allergy to bisphosphonates
12. Any radiation therapy for the treatment of bone metastases \<4 weeks prior to study start.
13. Any chronic medical condition which would preclude performance or adherence to protocol requirements
14. Inability to provide informed consent

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Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke

To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.

Setting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).

In addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.

Participants will be evaluated before training, after training, and at 3 month follow-up visit

Eligibility Criteria:
Inclusion Criteria:

* Adults with Hemiparesis after an unilateral first ever stroke
* Able to walk in security
* Time since stroke within 3 months to 1 year
* Sufficient cognitive function to understand and perform corresponding tasks

Exclusion Criteria:

* Any history of neurological disorders or cardiovascular instability
* High spasticity on ankle, knee, hip muscles
* Inability to exercise on a cyclo-ergometer
* Pacemaker and other contraindications of the use of electrical stimulation
Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Serum total cholesterol 5.2-8.5 mmol/l
* Serum triglycerides \< 3 mmol/l
* Signed written informed consent

Exclusion Criteria:

* Abnormal liver, kidney and thyroid function
* Use of lipid lowering medication
* Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* History of recent temporal ischemic attack or malignant diseases (\< 5 yrs)
* Celiac disease, or allergy or intolerance to the ingredients of the test products
* Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
* Subjects with alcohol abuse (\> 4 portion per day)
* Pregnancy or planned pregnancy or lactating
Preventing Depression in the Children of Depressed African American Mothers

The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.

Abstract

Background: There is limited representation of ethnic minorities in preventive interventions for the generational impact of maternal depression.

Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and contextually relevant for urban African American mothers with depression and their children. A pilot clinical trial (PIP vs. lecture) was conducted.

Eligibility Criteria:
Mothers:

Inclusion Criteria:

* African American
* Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise specified
* Parent or guardian and primary caregiver of a child 8 to 14 years old
* Resided at least part time for the past year with the targeted child
* May be receiving psychopharmacological treatment, psychosocial services, or both

Exclusion Criteria:

* Current or lifetime history of schizophrenia
* Current or lifetime history of bipolar disorder
* Current or past-year diagnosis of alcohol or drug dependency
* Serious medical disorder, neurological disorder, condition, or chronic pain that prevents participation
* Documented mental retardation
* Current suicide risk sufficient to preclude outpatient treatment

Children:

Inclusion Criteria:

* Have an African American mother with a depressive disorder
* 8 to 14 years old
* Reside at least part time with mother

Exclusion Criteria:

* Currently in treatment for depression or an anxiety disorder
* Presence of a medical or psychiatric condition contraindicating study intervention, such as mental retardation, suicidality, or pervasive developmental disorder