cyrilzakka/clinical-trials huggingface dataset:
Post Hemorrhoidectomy Anorectal Pain

This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce pain and increase relaxation. These patients will be surveyed at their post-operative visit regarding pain and other symptoms and at their one month post operative visit on the any hospitalizations and emergency room visits since their surgery.

The effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients will be assessed in this quality assurance trial. During the pre-operative clinic visit, patients to undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce pain and increase relaxation. In this year long study patient self-reported utilization of the breathing exercises and their level of pain, sleep quality, gastrointestinal symptoms (diarrhea, constipation, etc), emergency room visits, and hospitalizations in the month post hemorrhoid surgery will be evaluated. All patients will be asked to complete a brief survey at their pre-operative and one month post-operative visits.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective hemorrhoid surgery

Exclusion Criteria:

* Emergent/urgent hemorrhoid surgery
Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)

The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3）between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
2. 18 years old \< age \< 80 years old, no gender limit.
3. Patient is expected survival beyond 3 months.
4. No pregnancy or pregnancy plan within 3 months after surgery.
5. Nutrition risk score \<3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
6. No contraindication to surgery for anesthetic evaluation.
7. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.

Exclusion Criteria:

1. Patients with borderline resectable and unresectable malignancies.
2. Patients undergoing neoadjuvant chemotherapy or radiotherapy.
3. Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
4. Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
5. Operation transfers to open.
6. Operation transfers to other procedure.
7. The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.
Benefits and Risks of Newborn Screening for Cystic Fibrosis

Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive genetic disorder of the white population, there are often delays in diagnosis and hence start of treatment. Advances of the past two decades have made CF screening feasible using routinely collected neonatal blood specimens and measuring an enzyme level followed by CF mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF through neonatal screening will be medically beneficial without major risks. ''Medically beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include laboratory errors, miscommunication or misunderstanding, and adverse psychosocial consequences. Specific aims include assessment of the benefits, risks, costs, quality of life, and cognitive function associated with CF neonatal screening and a better understanding of the epidemiology of CF.

A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable has been underway since 1985. Nutritional status has been assessed using height and weight measurements and biochemical methods. The results have demonstrated significant benefits in the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans using high resolution computerized tomography, and pulmonary function tests. Other factors that we are looking at include risk factors for the acquisition of respiratory pathogens such as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and the costs of diagnosis and treatment of CF throughout childhood.

If the questions underlying this study are answered favorably, it is likely that neonatal screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will become the routine method for identifying new cases of CF not only in the State of Wisconsin, but throughout the country.


Eligibility Criteria:
Inclusion Criteria:

* Must have been born in the State of Wisconsin
* Must have been born between April 15, 1985 and June 30, 1994
* Must have had a valid newborn screening test for cystic fibrosis in the first 28 days of life.
* Must have a sweat chloride test greater or equal to 60 mmol/Liter
* Parental consent
Feasibility and Safety of AutoloGous UncondItioneD PEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)

This is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.

We recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van Horne et al., 2017, 2018; Quintero et al. 2022), reparative peripheral (sural) nerve tissue containing a variety of cells and neuroprotective factors (Chau et al. 2022). While our previous studies have used injury-activated peripheral nerve tissue (PNT), where the sural nerve is transected and allowed to regenerate in situ for up to about 2 weeks before implantation, here we propose to use naïve, previously uninjured, nerve tissue delivered bilaterally to the substantia nigra at the time participants are undergoing deep brain stimulation (DBS) surgery. Participants will be assessed preoperatively, then undergo DBS surgery and delivery of autologous PNT, and then assessed postoperatively at two weeks after surgery, 6 months, 12 months and annually thereafter for adverse events and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing DBS
* Diagnosis of clinically established or clinically probably PD (Parkinson's disease) as defined by MDS criteria
* Age 40-75, inclusive
* Able and willing to undergo ioflupane/SPECT
* Able to tolerate the surgical procedure
* Able to undergo all planned assessments
* Available access to the sural nerve

Exclusion Criteria:

* Any condition that would not make the subject a candidate for DBS
* Previous PD surgery or intracranial surgery
* Typical, nonparkinsonian syndrome ioflupane/SPECT signal
* Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
* Unable to undergo an MRI
* An obstructed trajectory path to the substantia nigra
Effectiveness of Community Health Workers in Hypertension Adherence

A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 60 years and older who had been diagnosed with hypertension for more than 3 months at the time of the study were eligible for inclusion.

Exclusion Criteria:

* People who are not able to answer interviews or have mental illnesses.
* Those who, after being interviewed, re-confirmed that they did not have a diagnosis of hypertension from a medical facility.
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients

Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.

Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of many genes (eg. gene responsible for erythropoetin production). It also stimulates angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes involved in extracellular glucose import.

Before starting the training program all participants will be assessed by cardiologist. Then the incremental exercise test will be performed to determine aerobic capacity (VO2max).

Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).

Training program will be the same for all participants: 60 minutes sessions twice a week for 6 weeks of mixed exercise: aerobic and anaerobic.

Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same glucometer model by all patients.

At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and blood pressure monitoring, lipid profile and diabetes control parameters will be performed in all patients.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes of at least 10 years duration
* low physical activity
* BMI 20-30 kg/m2
* treated with multiple insulin injections (at least 4) or insulin pump (continuous subcutaneous insulin infusion \[CSII\])
* negative ECG exercise test
* HbA1c ≤ 8,0%
* high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise
* use of advanced glucometer functions and experience in use of Free Style Libre (Flash Glucose Monitoring System, Abbott)

Exclusion Criteria:

* HbA1c \> 8,0%,
* advanced complications of diabetes \[pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)\]
* patients physically active (regular physical activities more than once a week),
* positive ECG exercise test, history of cardiovascular event or coronary heart disease.
Gabapentin for Perioperative Pain Relief in Surgical Abortion

Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
* English or Spanish speaking
* eligible for office-based surgical pregnancy termination

Exclusion Criteria:

* present use of gabapentin or pregabalin,
* renal disease
* sensitivity or allergy to gabapentin
* Missed abortion
OHRQoL Evaluation After Functional Therapy in JIA Patients

The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.

This prospective interventional study included 93 patients with JIA and TMJ disorders at the start of functional orthodontic therapy. Children were prospectively followed in the 24 months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were:

* JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;
* Clear signs or symptoms of TMJ arthritis based on clinical and radiological examination.
* No administration of intra-articular TMJ steroid injections throughout the course of the orthopaedic functional treatment.

Exclusion Criteria:

* previous orthodontic treatment;
* history of maxillofacial surgery;
* genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.
Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis

Trochanteric bursitis is a common condition, effecting 20% of the population. \\Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.

The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.

Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of trochanteric bursitis
2. 18 years of age or older when written informed consent is obtained
3. Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria:

1. Allergy to triamcinolone or bupivicaine
2. Coagulopathy
3. Active Infection
4. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)

The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.


Eligibility Criteria:
INCLUSION CRITERIA

* Rest angina lasting at least 10 minutes that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray, occurring within 24 hours of randomization;
* TIMI risk score greater than or equal to 4 (a qualitative test for CK-MB or Troponin may be utilized for screening purposes; however, a quantitative test must still be performed.)

EXCLUSION CRITERIA

* Increased bleeding risk as defined by any of the following:

  * Ischemic stroke within the last year
  * Any previous hemorrhagic stroke, intracranial tumor, or intracranial aneurysm
  * Recent (\<1 month) trauma or major surgery (including bypass surgery)
  * Active bleeding (other than minor skin abrasions)
* Impaired hemostasis including any one of the following:

  * Known International Normalized Ratio (INR) \>1.5
  * Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders)
  * Known or history of thrombocytopenia (platelet count \<100,000/mL)
  * History of thrombocytopenia with glycoprotein IIb/IIIa inhibitor therapy, heparin, or enoxaparin
* Angina from a secondary cause such as:

  * severe, uncontrolled hypertension (systolic blood pressure \>180 mm Hg despite treatment)
  * anemia
  * valvular disease
  * congenital heart disease
  * hypertrophic cardiomyopathy
  * restrictive or constrictive cardiomyopathy
  * thyrotoxicosis.
* Bundle branch block not known to be old in the context of angina.
* Undergone a percutaneous coronary intervention (PCI) within the past 24 hours.
* A known allergy to heparin, low molecular weight heparin, pork or pork products.
* Any contraindications to treatment with UFH or LMWH.
* A recent (\<48 hours) or planned spinal/epidural anesthesia or puncture.
* Thrombolytic therapy within the preceding 24 hours.
* Any other clinically relevant serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 mL/min\], rendering implementation of the protocol or interpretation of the study results difficult.
* Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial.
* Inability to comply with the protocol (e.g., has uncooperative attitude, inability to return for follow-up visits).
* Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent.
* A prosthetic heart valve
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 \[NCT02217475\] or the AURORA study \[NCT03028740\].


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
* Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
* Histopathological progression to cirrhosis
* Model for end-stage liver disease (MELD) score ≥ 15
* Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
* Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).

Exclusion Criteria:

* Prior or planned liver transplantation
* Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
An Evaluation of the Implementation of the Care and Monitoring at Home Program- A New Paradigm for Acute Care Management of Cancer Patients

To understand the experience of patients receiving care in the Care and Monitoring at Home program at MD Anderson. Researchers intend to use this information to study and possibly improve the hospital care at home program.

OBJECTIVES

Primary Objectives

The objective of this observational study is to assess the feasibility of providing hospital substitution hospital level care in the home for patients with cancer through the CaMH Program. Our primary gauge of feasibility will be a care escalation rate of \<20%, defined as the proportion of patients who initiate care in our HaH program but are transferred back to the inpatient setting to complete the care episode. This threshold is consistent with the published literature.15 In addition, a "feasible" designation will require a median score \> 3 on each of three post-discharge survey implementation measures - the Feasibility of Implementation Measure, Acceptability of Implementation Measure, and Intervention Appropriateness Measure.

Secondary Objectives

Secondary objectives will include patient experience and perception about CaMH, length of stay, rate of clinical adverse events during CaMH (falls, pressure ulcers, medication errors) and 30-days after discharge, 7-day readmission, 30-day readmission, and 30-day emergency department visit rate. (Note, the aforementioned adverse events could occur as a result of participation in CaMH. However, minimal adverse events are expected a result of participation in this observational study (see adverse events below)). A patient will be considered to have an ER visit or hospital readmission if these events are documented in the medical record OR the patient reports the event on the survey.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be eligible for enrollment in this study if they have accepted enrollment in CaMH. No patients will be excluded if they are enrolled in CaMH.
* Cognitively impaired adults will be able to participate in the study if an adults proxy provides informed consent and completes survey materials on their behalf.

Exclusion Criteria:

- Children and pregnant women will not be enrolled in the CaMH program, and therefore not eligible for this study.