cyrilzakka/clinical-trials huggingface dataset:
CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
* Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

Exclusion Criteria:

* Age \<19 years
* Unable to safely undergo EUS for any reason
* Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
* Unable to consent
* Non-English speaking patients.
* Previously undergone CPB
* Pregnancy and Breast feeding
* Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
* Previous pancreatic surgery
* Previous pseudocyst drainage
* Other documented causes of abdominal pain.
Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

Eighty adult patients undergoing open colon surgery will be randomized to either:

1. standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to
2. additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher\&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified ) in the open wound cavity.

PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide insufflated into an open surgical wound can be used to warm the core, the open wound cavity, and the wound edges during major abdominal surgery.

SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups regarding complications and clinical differences including histological signs of desiccation injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay, bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative signs of restored bowel function including bowel movements, flatus, and first meal.

Eighty patients undergoing open colon surgery will be randomized to either standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head or to additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher\&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity.

Wound temperatures will be measured every 10 minutes with an infra-red camera positioned approximately 1m above the wound with a camera support. Wound areas and wound edges of stored images will be delineated with a soft ware program. Peritoneal samples (3x3x1mm) will be taken at start of the operation, after 30 minutes and before closure of the abdomen. The samples will immediately be stored in RNA-later solution, and deep frozen for later analysis of epithelial (peritoneal) and endothelial function/tissue damage.

Eligibility Criteria:
Inclusion Criteria:

* major open abdominal surgery (colon surgery) in adults
* patient signed informed consent

Exclusion Criteria:

* acute surgery
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.

Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.

Eligibility Criteria:
Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR

Inclusion Criteria:

* Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
* Moderate to severe depression
* History of at least one documented mania or hypomania episode
* Absence of current mania or hypomania

Exclusion Criteria:

* Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
* Any substance disorder with the previous 6 months
* Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
* ECT within 6 months before the study
* Female of childbearing potential and not using adequate contraception
* Other protocol-defined inclusion and exclusion criteria may apply
A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results

This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at the point of encounter), and (2) standard of care for HIV and HCV testing.

This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at the point of encounter), and (2) standard of care for HIV and HCV testing. Secondary outcomes include linkage to care and HIV and HCV risk behaviors. Participants will complete a baseline assessment to report their demographics, sexual risk behaviors, drug-using risk behaviors, utilization of drug abuse treatment services and will be randomized to one of two groups. At one-month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV or HCV test results. At three months post-randomization, participants will complete a follow-up assessment to assess linkage to care and changes, if any, in their HIV and HCV sexual risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Report being HIV and HCV negative, or report not knowing HIV and HCV status
* Not have received results of an HIV or HCV test initiated within the last 12 months
* Able and willing to provide informed consent
* Seeking or currently receiving drug (excluding alcohol only treatment) abuse treatment services at the participating treatment programs
* At least 18 years old
* Able to communicate in English
* Willing to sign a release form that will allow medical record review (to corroborate self-reports of receipt of test results)
* Able and willing to provide locator information (contact number and address) for follow-up surveys
Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Recent evidence has shown that obese and overweight children exhibit states of chronic inflammation. In obese adults, a high carbohydrate meal induces an inflammatory response; however, the effects of a high carbohydrate meal on biomarkers of inflammation has not previously been examined in children. The purpose of this research project is to characterize the inflammatory response to a high carbohydrate versus a low carbohydrate meal in healthy weight, overweight, and obese children (age 7-17 years). After completing informed consent/assent, a Dual-energy X-ray Absorptiometry (DXA) scan, and baseline blood draw on experimental day 1, children will then return to the lab two times to ingest either a high or low carbohydrate beverage followed by post-meal blood collection for a total of 3 blood draws. Biomarkers of inflammation will be analyzed by flow cytometry and enzyme-linked immunosorbent assay (ELISA). Participants will be recruited through various studies through the Neurocognitive Kinesiology Lab/Body Composition and Nutritional Neuroscience Labs as well as through the local Champaign-Urbana community. Data from this project will provide a better understanding of the inflammatory response to different meals in healthy weight, overweight, and obese children.


Eligibility Criteria:
Inclusion Criteria:

• Between the ages of 7-17

Exclusion Criteria:

* Younger than 7 years and older than 17 years
* Presence of allergies to eggs and/or sugar substitutes
* Presence of heart or respiratory disease
* Presence of uncontrolled hypertension, diabetes
* Use of anti-inflammatory medications
* Presence of cancer or metabolic disease
Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients

By analyzing the relationship between the body constitution and the progression of Type II diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to provide an useful tool, body constitution, to stratify the patients accordingly for individualized health care.

The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed as Type II diabetes mellitus by Endocrinology specialist.
* aged from 20 to 75 years old.
* clear conscious, willing to join the program.

Exclusion Criteria:

* Severe mental illness, which lead to unable to fulfill the questionaire
* Major surgical intervention,medical events (such as acute myocardial infarction, cerebral vascular accident...et al.,), chemotherapy or radiation therapy within past one month , which made body constitution measurement unavailable.
Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).

Extracorporeal membrane oxygenation (ECMO) is a cardiopulmonary bypass device that provides life-saving, complete respiratory and cardiac support for children who suffer refractory heart or lung failure. While on ECMO, children are at increased risk of infection, including fungal infection. Antifungal prophylaxis can potentially reduce the burden of disease in children on ECMO. Because fungal infections can result in biofilms that are difficult to treat, treatment includes not only antifungal medications but also removal of any large intravenous lines. However, catheter removal for children on ECMO is impossible; therefore, therapy relies upon optimal antifungal management alone.

Micafungin is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Micafungin may be particularly efficacious in children on ECMO because of the drug's ability to penetrate biofilms. However, the ECMO circuit is known to substantially alter drug levels for many drugs, resulting in important dosing changes. Appropriate micafungin dosing in this setting is unknown and sub-optimal dosing might result in therapeutic and prophylactic failure.

Standard dosing of micafungin are 4 and 2 mg per kilogram of body weight given intravenously once daily for treatment and prophylaxis, respectively. Based on preliminary data and modeling from other studies, investigators hypothesize that 8 and 4 mg per kilogram given once daily will achieve proper drug levels to respectively treat and prevent fungal infections in children under 2 years of age who are supported by ECMO. Because the ECMO circuit should have less of an impact on volume of distribution in larger children, investigators hypothesize that in children from 2 to 18 years old, standard dosing of micafungin will achieve proper drug concentrations.

Investigators hold the FDA investigational new drug application (IND #115255) to give micafungin to children on ECMO at the doses described above. Blood samples will be collected at specific times around the first and fourth micafungin doses to describe the pharmacokinetics and drug extraction by the ECMO circuit.

Eligibility Criteria:
Inclusion Criteria:

* \<= 17.85 years at the time of enrollment.
* Sufficient venous access to permit administration of study medication.
* Supported with either venoarterial (VA) or venovenous (VV) ECMO.
* Availability and willingness of the parent/legal guardian to provide written informed consent.
* For treatment dosing arm: confirmed or suspected infection

Exclusion Criteria:

* Subject with a history of anaphylaxis attributed to an echinocandin.
* Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
* Previous participation in this study.
* Pregnancy
Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury

Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory.

Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known.

Uncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced.

Goal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment.

Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).

See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)

Eligibility Criteria:
Inclusion Criteria:

- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -

Exclusion Criteria:

* cognitive impairments
* a preexistent neurologic deficit of arms and/or legs
* psychiatric illness
* significant comorbidity interfering with the indication to perform surgery or not
* use of anticoagulating drugs
* addiction to drugs or alcohol (more than five units daily)
* not speaking Dutch language fluently
* not willing to participate
* participating in another trial
Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy

Rationale of this research is to evaluate the outcome of trunk stabilizing exercises on the fine motor skills of subjects with hemiplegic CP. The significance of this study is to identify how much core stability exercises improve hand function. This study will help gather evidence on the practice of core stabilizing exercises to improve hand function so that it can help both physicians and patients.

Cerebral palsy is a permanent damage in early brain in fetus which leads to movement disorder. The most frequent reason of bodily incapacity is cerebral palsy in pediatric population. CP children have difficulty maintaining dynamic and static trunk stability, which leads to affect sitting, standing, reaching and walking. Hemiplegic Cerebral palsy patients are challenged by fine motor skills, like gripping or object handling, which are essential for activities of daily life.the purpose of the study was to evaluate the effects of trunk stability exercises on hand function in children with cerebral palsy.It was a randomized, controlled trial, conducted among hemiplegic cerebral palsy patients. Sample size was 26 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on three occasions: (i) baseline (ii) post-intervention and (iii) after 4 weeks follow to assess long term effects.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female were included
* Age group 6 to 18 years.
* Medical diagnosis of hemiplegic cerebral palsy assured.
* Unilateral Movement deficit (less than 2.5) on amount of use scale on MAL (motor activity log).
* Level 1 to 3 on manual ability classification system (MACS).
* Mild to moderate spasticity of upper extremity (MAS grade 1 to 2.)
* GMCS level I-II.
* Subjects were cognitively capable and competent to follow the instructions

Exclusion Criteria:

* Patients with altered conscious level.
* Previous surgery or pain in upper limbs.
* Rigid contracture and fixed deformities in the spine
* Auditory / vision problem.
* Previous Botulinum Toxin-A injections in upper limb.
* Cardio-respiratory problem
Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Older dan 45 years old,
* With hand joint chronic discomfort,
* Regularly uses of paracetamol or NSAIDs to manage pain,
* Painful symptoms must have been present for more than 6 months,
* The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.

Exclusion Criteria:

* Related to previous and associated treatments:

  * Corticosteroids injection in the 3 previous months, whatever the joint concerned,
  * Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),
  * Anticoagulant (coumarinic) treatment and heparin,
  * General corticotherapy in the 3 previous months,
  * Contraindication to paracetamol, curcumin, boswellia and NSAID's.
* Related to associated pathologies:

  * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  * The patient has rheumatoid arthritis or gout,
  * The patient has a bile obstruction.
* Related to patient:

  * Pregnant or breastfeeding women.
Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle

The objective of this research study is two-fold, 1) to determine if body composition and body image perception are affected through the different phases of the menstrual cycle, and 2) if an acute session of resistance training can have different effects depending on the menstrual cycle phase.

The purpose of the research is to establish whether body composition and body image perception are affected throughout the different phases of the menstrual cycle and if the perception can be modified through resistance training. To the best of our knowledge, only one study has analyzed the effects of the menstrual cycle on body image perception. However, research analyzing the effects of the menstrual cycle on both body image perception and, body composition is lacking. Furthermore, research in the effects of resistance training on menstrual cycle-related changes on both perceived and measured body composition are inexistent. Findings from this study have the potential to increase the knowledge about resistance training's effects in modulating body image perception throughout the menstrual cycle. Further understanding of these responses may set the groundwork to develop exercise intervention programs to reduce the risk of developing more serious mental conditions linked to unhealthy body image perception.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Sedentary or Active
* 18.5-34.9 kg/m2 BMI
* Normal menstrual cycle defined as 28 to 30 days and a duration of 3 to 7 days
* Age range is 18-45 years old
* The inclusion of other participants may alter the results as an increase in body fat has been linked to known changes in different hormonal levels and those changes might influence substrate utilization
* Changes in the hormonal status of pre-menopausal women may appear without symptoms
* Younger females also display variations in their hormones since they are going through the process of development

Exclusion Criteria:

* Previous physiological and mental health history
* Pregnant females
* Males
* Irregular menstrual cycle, menstrual dysfunction or unusual sex hormone levels
* Musculoskeletal injuries
* Contraceptives, a medication that alters hormonal or cardio-respiratory responses
* Pre-menopausal symptoms
* On moderate to high-intensity exercise regime more than 2 days/week
Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome

The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.

Participants must be 18-75 years of age, African American, and have a combination of high blood pressure, insulin resistance (Type 2 Diabetes), low HDL cholesterol levels or obesity.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Hypertension and one of the following:
* Fasting glucose \> 100 mg/dl
* HgA1C\> 6.0 %
* Plasma triglycerides \>150
* HDL cholesterol \< 40 mg/dl in men or \< 50 mg/dl in women

Exclusion Criteria:

* History of Heart failure
* use of insulin
* non-dominant arm circ \> 50 cm.