cyrilzakka/clinical-trials huggingface dataset:
Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease

* compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis.
* compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.

Established renal disease is a signiﬁcant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1).

Anesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2).

Postoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inﬂammatory drugs are always avoided due to their deleterious effects on urine output (3).

Pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4).

The use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients of less than 18 years old.
* with chronic kidney disease.
* undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.

Exclusion Criteria:

* Patient known to have allergy to the studied drugs.
* Patients with contraindications to regional anesthesia.
Pergolide Treatment for Substance Abusers - 4

The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine dependence.


Eligibility Criteria:
Please contact site for information.
The Effect of Cholecalciferol in Pre-frail Elderly

Vitamin D plays important role in musculoskeletal health and has been known to influence immune system. Inflammaging is one of risk factors that may contribute to development of frailty in elderly.

The purpose of this study is to determine the effects of cholecalciferol in pre-frail elderly receiving calcium supplementation on handgrip strength, gait speed, vitamin D receptor, IGF-1 and IL-6. Fall incidence and improvement of frailty status will also be assessed.

This is a randomized double-blind placebo-controlled study in pre-frail elderly. Measurement of frailty status based on Fried frailty phenotype criteria (weight loss, weakness, exhaustion, slowness, low physical activity level) .

Subjects who fulfill eligibility criteria will be randomized into 2 groups, one group will received cholecalciferol 4000 IU once daily and the other group will received placebo once daily. Each subjects in both groups will received calcium lactate 500 mg once daily. Intervention will be held for 12 weeks.

Handgrip strength and gait speed will be assessed at baseline, every 4 weeks, and at week 12. Other outcome measures will be assessed at baseline and at week 12.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-frail elderly
2. Capable to understand and carry-out the instruction

Exclusion Criteria:

1. Allergic to cholecalciferol, calcium, or its components
2. Hypercalcemia (total serum calcium \> 10,5 mg/dL)
3. Unwilling to stop using drug contain vitamin D or vitamin D analog or calcium
4. Using steroid or NSAID routinely
5. Acute illness during inclusion period, eg. pneumonia, stroke attack, acute exacerbation of chronic obstructive pulmonary disease, asthma attack, hypertensive urgency/emergency, acute decompensated heart failure
6. Having condition that can affect measurement of handgrip strength and gait speed, eg. hemiparesis, severe pain in extremities
7. Hepatic cirrhosis, malignancy, autoimmune disease, nephrolithiasis, malabsorption syndrome (eg. chronic diarrhea) , diabetes mellitus with HbA1c \> = 8% in the last 3 months, diabetes mellitus with obvious sign and symptoms of catabolic decompensation (polyphagia, polydipsia, polyuria), chronic kidney disease stage IV-V or decreased renal function with estimated glomerular filtration rate \< 30 ml/minute/1,73 m2
8. Using drug that can affect vitamin D absorption, eg. bile acid sequestrants
9. Cognitive impairment (Abbreviated Mental Test score \< 8)
10. Depression (Geriatric Depression Scale score \> = 10)
11. Unwilling to join the study
The Effect of Obesity in Dexmedetomidine Metabolic Clearance

The purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.

The investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. Results will be based on a population pharmacokinetic modeling analysis performed in NONMEM program. The investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. A pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.

Eligibility Criteria:
Inclusion Criteria for obese patients:

* American Society of Anesthesiology classification I-III patients.
* Both genders.
* Age between 18 - 60 years.
* Body mass index higher than 40 Kg/m2.

Inclusion Criteria for non-obese patients:

* American Society of Anesthesiology classification I-II patients
* Both genders.
* Age between 18 - 60 years
* Body mass index lower than 30 Kg/m2.

Exclusion Criteria:

* Known allergy to study drugs
* Uncontrolled hypertension.
* Heart block greater than first degree.
* Chronic hepatic and kidney disease.
* Patients taking any drug acting in the central nervous system within 24 hrs before surgery.
* Patients taking drugs that induce overexpression of liver cytochrome P450-complex enzymes (Carbamazepine, Phenytoin, Phenobarbital, Rifampicin, Dexamethasone, Griseofulvin, Terbinafine, Prednisone, Hydrocortisone, Modafinil).)
* Known addiction to illicit drugs.
* Pregnancy.
* Current or past oncologic disease.
Designing a Programming Language for Patient-Oriented Prescriptions

The purpose of this study is to create a human-readable and executable computer language to implement medical prescriptions and to evaluate and refine this language, with the goal of improving safety and efficacy of patient care.

Preventable errors in healthcare are a leading cause of patient injury and death. Despite extensive effort and the expenditure of billions of dollars, computerization has failed to solve this problem. Research has shown that software design and debugging of a paper prescription markedly decreases the rate of injury and death associated with use of opioids in hospitalized patients. To further the application of insights from software engineering to the practice of medicine, the PIs will design and build a Patient-Oriented Prescription Programming Language (POP-PL) and evaluate if this new platform can be used to improve medical management of patients. The design of POP-PL will be based on building an understanding of the process of medical treatment of patients. This project is a collaboration between computer scientists and clinicians at Northwestern Medicine. The collaborating clinicians are co-investigators on this research project and also are providing healthcare to the patients that are being observed. The computer scientists and other research staff have undergone human subjects research training and are co-investigators on this research project as well. The clinician-investigators will oversee research project staff during all observations of patients, clinical encounters between healthcare providers and patients, and interactions between healthcare providers and healthcare information systems. Researchers involved in this study will observe interactions between health care providers and patients and will collate these observations with data from electronic data sources. Since this research is based mainly upon observation and chart review and will not involve any interventions or changes to patient care, the risk to study participants is minimal, involving inadvertent disclosure of healthcare information. This risk will be mitigated by anonymizing collected data.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 50 years old who receive care at the Northwestern Maternal Fetal Medicine Clinic (MFM)
* Patients between the ages of 18 and 50 years old who visit Northwestern Medicine outpatient facilities and are patients of a clinician who is a coinvestigator on this project.
* Patients who are between the ages of 18 and 50 years old, are hospitalized at Northwestern Medicine inpatient facilities, and are patients of a clinician who is a coinvestigator on this project.

Exclusion Criteria:
Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (\~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.


Eligibility Criteria:
Inclusion Criteria:

* Measurable metastatic carcinoma of the colon or rectum.
* 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor \[EGFR\] targeted therapy)
* Chest/abdomen/pelvis scans every 6-12 weeks
* ECOG 0-2
* Hemoglobin (Hgb) \> or = 8g/dl within 7 days prior to enrollment
* Age \> or = to 18 years of age

Exclusion Criteria:

* Cumulative weekly blood draws exceeding 150mL/week
* Brain metastasis
* Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
* Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
Brain's Response to Chocolate

The purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate. Eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain. The researchers believe this dopamine response can be measured by looking at the individual's eye.

With obesity at an all-time high, understanding eating behavior beyond physical need is a priority. Food reinforcement is driven by central dopamine activity. However, objective measurement of brain dopamine-related behavioral events is hindered by the lack of non-invasive, accessible techniques that are amenable to testing in a "naturalistic" environment. The goal of this project is to develop a non-invasive, accessible methodology to measure dopaminergic responses to food in a natural setting. This research will use a novel, hand-held electroretinograph (ERG) that does not require eye dilation and uses a skin electrode to measure retinal dopamine activity. Previous work establishes that retinal dopamine activity can be used as a proxy for central dopamine function. The ability to assess both subjective behavioral variables and central dopaminergic responses simultaneously will provide an ideal approach for innovative studies of the control of eating behavior.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 20-30 kg/m2
* free of any major illness or disease

Exclusion Criteria:

* food allergies
* participation in a weight loss diet or exercise program
* pregnancy
* lactation
* metabolic illness or disease (diabetes, renal failure, thyroid illness, hypertension)
* eye illness or disease (narrow angle glaucoma, macular degeneration, retinal detachment, cataracts)
* psychiatric, neurological or eating disorders (schizophrenia, depression, Parkinson's Disease, Huntington's Disease, cerebral palsy, stroke, epilepsy, anorexia nervosa or bulimia nervosa)
* take prescription medications except for oral contraceptives or antihyperlipidemia agents
Clinical Outcomes of Biologically Oriented Preparation Technique

This study aims to evaluate the periodontal response of teeth prepared with a biologically oriented preparation technique (BOPT) compared to conventional preparation for all-ceramic crowns.

The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations.

This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns.

Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18.
* Two teeth at least needed to be restored with full crowns (each patient needs at least two single crowns).
* Stable occlusion.
* Good oral hygiene.
* Periodontally healthy teeth.
* Nonsmoking or smoking less than ten cigarettes/day.
* Probing depth between 1 and 3 mm.

Exclusion Criteria:

* Patients younger than 18.
* Parafunctional habits.
* Active periodontal disease.
* Poor oral hygiene.
* Systemic disease that may affect the periodontal health.
* Pregnancy.
* Radiation or chemotherapy.
* Treatment by Bisphosphonates medication.
* Patients who are unable or unwilling to attend follow-up visits
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis

The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.


Eligibility Criteria:
Inclusion Criteria:

1. At Visit H-1 (start of the treatment period), the participants must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 15% or more of the total participants.
2. Outpatients (including inpatient for examination)
3. Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.

Exclusion Criteria:

1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit H-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder
The Effects of Rifaximin Therapy in Irritable Bowel Syndrome

To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel syndrome, and implement it into clinical practice.

Irritable Bowel Syndrome(IBS) is a chronic relapsing disorder with unknown etiology characterized by abdominal pain and bowel habit changes without an organic pathology. Pathophysiology is not fully understood, bacterial overgrowth is one of the reasons. Because of that, use of drugs effective on the gut flora has been raised; Rifaximin is one of them. This study investigated the effectiveness of Rifaximin on IBS.

This randomized, double-blinded, controlled study began with 500 patients(144 of them removed because of incompliance). Patients those without organic bowel pathology and whom meet the Rome-III criteria, aged between 19-50 yo were enrolled in the study. Patients with known Rifaximin allergy, lactose intolerance, and those having treated for IBS whit in last 1 month as well as those with alarm symptoms (melena, fever, weight loss, anemia, rectal bleeding) were excluded. After routine biochemistry, blood count, and stool tests, Rifaximin tablet was given to a group as 1200 mg. daily in 3 divided doses, placebo tablet was given to another group in same doses for 10 days. Improvement in symptoms were scored and recorded on 10.day, 3. and 6.week. In addition to descriptive statistical methods(mean±SD), Student's-T and Mann-Whitney U-tests were used for comparison of quantitative data, chi-square and McNemar tests were used for comparison of qualitative data. Significance was accepted if p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 50 years without alarm symptoms, who were examined at the Gastroenterology Clinic, without endoscopic assessment, due to complaints of Irritable Bowel Syndrome, and pre-diagnosed with Irritable Bowel Syndrome according to the Rome III criteria, will be included in the study.

Exclusion Criteria:

1. are under the age of 18 years,
2. are allergic to Rifaximin,
3. are pregnant and lactating,
4. have documented diseases of the gastrointestinal system (such as gastric and duodenal ulcers, gastric cancer, small intestine and colon cancer, inflammatory bowel disease \[Crohn's and Ulcerative Colitis\], gastroparesis, chronic intestinal ischemia, etc.),
5. have (describe) documented diseases of the pancreas, biliary tract, and liver (such as pancreatitis, biliary colic pain associated with gallstones, acute cholecystitis, choledochal stone, hepatitis, hepatobiliary cancers, etc.),
6. have previously undergone major abdominal surgery,
7. have a systemic disease (such as collagen tissue disorders, kidney dysfunction, systemic infection, etc.),
8. have an identified psychiatric disorder,

   and/or
9. consume alcohol excessively
Preoperative Warming and Perioperative Shivering

Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.

Forced air warmers are the most frequently used active warming devices in the peri-operative setting. Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. Although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. It is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. New guidelines recommend that patients core temperature has to be maintained at \>36°C, postoperatively. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.

Forced air warmers are the most frequently used active warming devices in the peri-operative setting. They are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices.

Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

Eligibility Criteria:
Inclusion Criteria:

* All patients going under therapeutic laparoscopic surgery
* All patients between 15-70 years irrespective of their gender
* ASA 1-3 patients
* Those who have given informed consent

Exclusion Criteria:

* Any patient undergoing diagnostic laparoscopic surgery
* Patients below age of 15 yrs
* ASA 4 or higher patients
* Patients not giving informed consent