cyrilzakka/clinical-trials huggingface dataset:
Effect of Mindful Eating on Body Mass Index in Obese Adolescents

This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.

40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.

Eligibility Criteria:
Inclusion Criteria

* BMI at or greater than the 95th percentile for age and gender

Exclusion Criteria
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. There is a significant association between heightened stress and sarcoidosis-associated fatigue. The proposed project will evaluate the usability/feasibility of a smartphone-based stress management application for the self-management of sarcoidosis-associated stress and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Sarcoidosis diagnosis based on established criteria
* ≥18 years old
* able to speak, hear, and understand English
* elevated SAF (FAS score ≥22)
* owns smartphone with current data plan
* willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)

Exclusion Criteria:

* history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months
* positive screening for potential major depression (Patient Health Questionnaire depression scale \[PHQ-8; α = .86\] score ≥10)
* untreated sleep apnea (based on home sleep study testing)
* sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications
* \>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)
* active substance abuse or binge drinking (\>21 drinks/week )
Healthy Heart Habits

Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.

Depression predicts high rates of morbidity/mortality among acute coronary syndrome (ACS) patients. Part of this relationship is explained by a poor profile of behavioral risk factors (i.e., smoking,physical activity, medication adherence, diet). An integrated treatment targeting both depressed mood and multiple behavioral risk factors could be highly effective in reducing post-ACS mortality. Behavioral Activation for depression may be an ideal counseling treatment for this since it has recently shown promise for facilitating behavioral risk factor changes in ACS patients with depression (K23HL107391). The current study adapts this manual targeting post-ACS depressed mood and smoking cessation to target depression and multiple behavioral risk factors post-ACS. This study will be an open trial (N=20) to test the feasibility and acceptability of our procedures and obtain initial indications of efficacy. This study hypothesizes that 1) the BA-HD manual and study procedures will be feasible and acceptable to post-ACS patients with depressed mood as measured by self-report, recruitment/retention rate, and post- treatment qualitative interviews and 2) that participants will experience clinically significant improvements in depressed mood and behavioral risk factor profile. The long-term goal of this research is to improve long-term survival rates following ACS.

Eligibility Criteria:
Inclusion criteria:

* ACS diagnosis (diagnosis of unstable angina, ST and non-ST elevation myocardial infarction) documented in medical record in the preceding 2-12 months
* Current diagnosis of depression documented in medical record, OR clinically administered PHQ-9 score of 10 or greater documented in the medical record in the preceding 12 months, OR CES-D score greater than or equal to 10
* current non-adherence to 1 or more of 4 more behavioral risk factors
* willing to make immediate changes to one or more of the relevant behavioral risk factors
* age of 18-75
* lives within 1.5 hours of Hennepin Healthcare
* fluent in English.

Exclusion criteria:

* Limited mental competency (as indicated in medical chart)
* presence of current exacerbation of psychosis/serious mental illness or suicidality
* in hospice care
* currently attending regular counseling targeting depression or any health behavior change
* currently attending a cardiac rehabilitation program (those excluded for being in rehabilitation will be re-contacted after completion)
Ganglioside and IBD

Context. Inflammatory bowel disease (IBD) is a chronic and debilitating disorder. Novel treatment strategies aimed to resolve intestinal inflammation and induce disease remission are necessary. Dietary gangliosides are safe for consumption, bioavailable, and have shown clinical benefit in patients with inflammatory intestinal disease.

Objectives. The primary objective is this study is to determine the efficacy of dietary ganglioside in improving disease activity indices in pediatric patients with IBD. Secondary objectives include demonstrating the effectiveness of dietary ganglioside for improving quality of life, improving intestinal integrity, and reducing inflammation.

Study Design. Intervention: controlled trial (pilot). Participants. Inclusion criteria: aged 9-21 years, diagnosis of ulcerative colitis (UC) or ileal or colonic Crohn Disease (CD), active disease. Exclusion criteria: pregnancy, inadequate liver or renal function, active infectious disease, previous bowel resection, disease remission, drug/alcohol abuse, other serious medical conditions, indeterminate colitis.

Study Intervention. Patients with IBD (n=48) will be allocated to consume ganglioside treatment or placebo daily for 10 weeks. Treatment group will consume five grams of buttermilk powder daily or anhydrous milk fat.

Outcome Measures. The primary outcome is the disease activity index: pediatric Crohn's Disease Activity Index (pCDAI) or pediatric Ulcerative Colitis Activity Index (pUCAI). Secondary outcomes include: quality of life (IMPACT-III questionnaire), intestinal permeability (lactulose/mannitol urinary assay), C-reactive protein (CRP; blood exam), calprotectin (fecal exam).

Expected Outcomes. Relative to the placebo group, the treatment group will have improved disease activity indices, quality of life, and intestinal integrity over the 10-week study period. The treatment group will also show reduction in inflammation and calprotectin relative to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Participants age 9-21 years
2. Mild-moderate IBD defined by ImproveCareNow (ICN) Physician Global Assessment (PGA); OR severe IBD defined by ICN PGA if stable for at least 120 days
3. Ileal, ileocolonic, colonic location of disease

Exclusion Criteria:

1. Pregnancy
2. Previous bowel resection
3. Non-ileocolonic location of disease
4. Inadequate liver or renal function
5. On prescription medication for active infectious disease
6. Drug/alcohol abuse
7. Other serious medical conditions
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal carcinoma
* Suitable for first-line treatment of metastatic disease

Exclusion Criteria:

* Peripheral neuropathy greater than Grade 1
* Adjuvant therapy within 6 months prior to study treatment
* Prior oxaliplatin
* Prior pelvic or whole abdomen radiation
* Any history of coronary angioplasty or history of myocardial infarction
Sphenopalatine Ganglion Blocks RCT

RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.

SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.

Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.

With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.

We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more at time of consent
2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
3. Ability to provide consent for the research study

Exclusion Criteria

1. Pregnant or breast feeding within 4 weeks of enrollment
2. Inability to communicate with the study team
3. Patients who cannot read and understand English
4. Deemed unsuitable for enrollment in study by the investigator
5. Allergy to local anesthetics or saline
Prevention of Coronary Heart Disease in Morbidly Obese Patients

The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months.

Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly Obese patients with BMI \> 40, or BMI \> 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

Exclusion Criteria:

* Participation in other weight loss program the last 12 months. Serious psychiatric conditions
Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?

The purpose of the study is to compare the efficacy of intra-articular hydraulic distension (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and capsule-preserving IHDs.

The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure within the joint space. Although IHD is one of the most common treatment options for the PSS, the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid rupture, thus producing less satisfactory outcomes. However, we devised in our previous study a novel technique that enabled a physician to infuse the possible largest volume without rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.

Eligibility Criteria:
Inclusion Criteria:

* shoulder discomfort for at least one month
* limited range of motion of the glenohumeral joint in at least two directions

Exclusion Criteria:

* systemic inflammatory joint disease
* radiological evidence of bony abnormality of the shoulder
* full-thickness rotator cuff tear
* acute systemic medical illness
* history of major trauma or surgery involving the shoulder
* contraindication to intra-articular, local anesthestic injection
OSA Screen Negative With Spinal Duramorph

Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI\>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.


Eligibility Criteria:
Inclusion Criteria:

* OSA screen negative per hospital protocol
* age 18 or greater
* BMI\>35
* consent to participate to wear capnography and pulse oximetry monitoring devices post delivery

Exclusion Criteria:

* Spanish speaking only
* under age 18
* contraindication to receiving drugs utilized in delivery anesthetic
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia

The purpose of this study is to ascertain the safety and efficacy of

Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal

Cicatricial Alopecia.

Central Centrifugal Cicatricial Alopecia (CCCA) is an inflammation-induced

hair loss starting in the central scalp and progressing centrifugally. The

cause of CCCA is unknown. Early diagnosis and treatment is essential to stop

or slow the progression of scarring and permanent hair loss. Once scarring

occurs, the hair follicles are obliterated and the hair cannot regrow. Thus,

anti-inflammatory medications are used to decrease inflammation. Current

treatment includes topical and intralesional corticosteroids, oral

antibiotics, and hair transplantation, all which may take months to years to

show improvement. There is no evidence-based medicine on how to treat

primary cicatricial alopecias. Clobestasol Propionate 0.05% Emollient Foam is

an FDA-approved and marketed topical corticosteroid for the treatment of the

inflammatory and pruritic manifestations of moderate to severe corticosteroid-

responsive dermatoses of the scalp. Many studies found the foam to be less

irritating than the original formulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CCCA, treated or untreated
* Score 0 - 1 on Scale/Questionnaire
* 18 years of age or older
* Women of African descent

Exclusion Criteria:

* Score \> 1 on Scale/Questionnaire
* Alopecias other than CCCA, including alopecia arreata, lichen planopilaris, trichotillomania, and traction alopecia
* History of hair transplantation
* Children less than 18 years of age
* Males
* Women of non-African descent
* Pregnancy or breastfeeding. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms)
* Anti-dandruff shampoo within 30 days
* Anti-inflammatory medications such as antibiotics (doxycycline, minocycline, rifampin, etc.), steroids (oral prednisone, topical corticosteroids,etc.), NSAIDs (ibuprofen, aspirin, etc.)
Effect of Muscle Pain in Late Cold Water Immersion, Muscular Recruitment, Postural Control Dynamic and Sleep Quality

Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness, muscle recruitment, dynamic postural control and quality of sleep in young soccer players.

Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same football club and with the same routine practices and games. At first athletes will respond to the IC and will be submitted to the test of a repetition maximum. After three days the athletes will analysis of muscle recruitment by electromyography and dynamic posture control through the force platform both during the time of shooting, moreover, will respond to scale the quality of sleep the previous night and one on pain, then they are instructed to perform a fatigue protocol for the quadriceps and then will be randomized to one of four intervention groups: cold water immersion, submersion in water at room temperature, or active recovery control. The same APPRAISAL be remade into three new moments, 24, 48 and 72 hours after the fatigue test.

Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle, quality of sleep the night after intervention protocol, electromyographic analysis of the rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as well as postural control when the shot off.

It is intended to establish the best way of recovery of late quadriceps muscle pain and contribute to the clinical practice of active recovery or rest in young soccer players.

The size and power of the sample was raised with use of sample size calculation, the Power and Sample Size program with a 95% confidence interval, alpha level of 5% and power of 80%, considering the mean and standard deviation of data DOMS study the Effects of Cold Water Immersion after Rugby Training on muscle Power and Biochemical Markers. Thus, the sample was set at 48 volunteers, 12 distributed to each of the four groups.

Participate in the study 28 soccer players, aged between 16 and 21 years, male, with training at least 5 times a week, no complaints of musculoskeletal pain or history of muscle injuries in the past six months, hired a same club with the same demand for training and competitions.

Exclusion criteria will be observed vascular problems, allergy to cold, surgery of the lower limbs in the past six months, athletes in viral states (such as colds or flu).

These will be randomized into four groups: cold water immersion (N = 7) immersion in water at room temperature (n = 7), active recovery (n = 7) and control (N = 7).

Eligibility Criteria:
Inclusion Criteria:

* Soccer players
* Aged between 16 and 21 years
* Male
* Train at least 5 times a week
* No complaints of musculoskeletal pain or history of muscle injuries in the past six months
* Hired at the same club with the same demand for training and competitions

Exclusion Criteria:

* Exclusion criteria will be observed vascular problems
* Allergy to cold
* Surgery of the lower limbs in the past six months
* Athletes in viral states (such as colds or flu)
Lymphatic Mapping After Previous Breast Surgery

Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.

Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.


Eligibility Criteria:
Inclusion Criteria:

* treatment with BCT with SNB and/or ALND for primary breast cancer
* previous primary breast cancer located in the upper-outer quadrant of one breast
* Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.

Exclusion Criteria:

* breast surgery for other reasons than breast cancer
* recurrent breast cancer
* former allergic reaction to 99mTc-colloidal albumin.
High(Deadlift) Versus Low Intensity Motor Control Exercises on Low Back Pain

The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain


Eligibility Criteria:
Inclusion Criteria:

* low back pain over 3 month
* the pain must originate locally from the lowe back and be nociceptive

Exclusion Criteria:

-
Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction

The purpose of this study is to evaluate the effect of Xinyue Capsule in the improvement cardiac function and reduction the level of heart failure biomarker NT-proBNP in patients suffering from HF with an ejection fraction greater than or equal to 50%. Researchers will also collect information on how much the heart disease has impact on patient's lives, and how well Xinyue Capsule treatment is tolerated. The study plans to enroll 246 male and female patients of the age of 18 years and above suffering from heart failure with ejection fraction greater than or equal to 50%. Participants will take the study product as oral tablet with a dose 0.6 g Tid daily. Study duration will be up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, and signed informed consent provided;
2. Presence of symptoms such as dyspnea (including exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea), fatigue, poor appetite, and bilateral lower limb edema;
3. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, and meeting at least one of the following criteria:

   * NT-proBNP ≥ 125 ng/L (sinus rhythm) or NT-proBNP ≥ 365 ng/L (atrial fibrillation);

Exclusion Criteria:

1. Usage of Xinyue Capsule or other Chinese patent medicines/herbal remedies aimed at alleviating heart failure symptoms or biomarkers within the past 90 days;
2. Known intolerance or significant allergic reaction to Xinyue Capsule;
3. Occurrence of cardiovascular adverse events within the past 90 days;
4. Acute decompensated heart failure, life-threatening arrhythmias, acute myocardial infarction, or cardiogenic shock;
5. Heart failure secondary to pulmonary hypertension, anemia, thyroid disorders, chronic obstructive pulmonary disease, or musculoskeletal disorders;
6. Presence of cardiac amyloidosis, storage diseases (hemochromatosis, glycogen storage disease), severe valvular heart disease, severe infections, malignancies, or significant hepatic or renal insufficiency.
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.


Eligibility Criteria:
Inclusion Criteria:

* Class I, II blowout floor fracture.
* Presented within 2 weeks of trauma.
* Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.

Exclusion Criteria:

* Comminuted orbital fractures involving the rim.
* Associated globe injuries.
* Delayed presentation.