cyrilzakka/clinical-trials huggingface dataset:
Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults between the ages of 40 - 80
* Undergoing a colonoscopy at any of the study locations for:

  i. CRC screening (first colonoscopy or 10 year follow up of negative exam). ii. Surveillance (prior colonoscopy with polyps). iii. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.
* Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
* For the purposes of informed consent, participants must be able to understand and read English.

Exclusion Criteria:

* Inability to provide informed consent
* Active or suspected pregnancy
* Patients referred due to incomplete colonoscopy or for removal of difficult polyps
* History of problems with sedation or anesthesia -. Participants electing to be unsedated for colonoscopy
* Patients undergoing multiple procedures (e.g. upper and lower endoscopy)
* Previous colon resection surgery
* Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Patients with a history of colorectal cancer or other intra-abdominal malignancy.
* Patients with open or recent wounds or skin rash on the anterior abdominal wall.
* History of cirrhosis or ascites
* Known ventral or umbilical hernia
* Patients who are medically unstable(American Society of Anesthesiology Class III or above).
Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures

To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.

The purpose of this study is compare skin closure via suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis. Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be reason to use tissue adhesives over traditional sutures. In these surgeries, there are five to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee opinion), so if the investigators can show significant time reduction for closure, that should reduce operative time and costs. To the investigators' knowledge, this will be the first study of its kind to make this comparison for urogynecologic robotic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St. John Hospital and Medical Center from March 19, 2018 - November 30, 2018.

Exclusion Criteria:

* We will exclude women with active skin infections as they may contribute to poor wound healing and infections. We will also exclude procedures that are converted to laparotomy.
Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture

This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.

This randomized clinical trial alongside a cost-effectiveness analysis will include edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive an implant (Titamax TI cortical - Neodent, Brazil) in the mandibular midline followed by the immediate connection of an O-Ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility Criteria:
Inclusion Criteria:

* To present favorable general health and the need to be rehabilitated with a new set of complete dentures
* To agree to be randomly assigned to one of the two study groups
* To be able to comprehend and answer the data collection instruments.

Exclusion Criteria:

* Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
* Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
* Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
* Inability to attend to the scheduled appointments and follow-up visits
Tailoring TM-HTN Intervention for Black Patients

Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.

Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be African American or Black
* experiencing socially disadvantage
* Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP \>130 mmHg using the mean of two research BP values measured by trained staff
* Subjects must be on stable Blood Pressure medications for the preceding 6 weeks

Exclusion Criteria:

* Unable to read or speak English
* diminished ability to measure home Blood Pressure
* chronic kidney disease ≥stage 4
* persistent/chronic atrial fibrillation
* severe hypertension \>180/110 mmHg
* acute health changes in past 3 months increasing chance of Blood Pressure instability
* terminal illness
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects between 18 and 70 years of age, inclusive
* Primary diagnosis of narcolepsy with cataplexy
* Willing and able to comply with the study requirements

Exclusion Criteria:

* Other clinically significant conditions potentially causing EDS
* Clinically significant psychiatric disorders
Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children

Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

HYPOTHESIS:

Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.

Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. There are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. All the studies showed significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. However, these studies are carried out in adults. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.

Exclusion Criteria:

* Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
* Children who had received montelukast within one week of arrival.
* Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
* Children with altered sensorium/unable to take oral medication.
Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major portal vein tumor thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 20 years of age
* Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
* Eastern Cooperative Oncology Group performance status 0 or 1
* HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
* Cirrhotic status of Child Pugh class A or B7
* Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
* Patient or guardian must be able to provide verbal and written informed consent

Exclusion Criteria:

* Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
* Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
* Uncontrolled inter-current illness except liver cirrhosis
Comparison of Fatigue in Varying Hot Environments

The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.

After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.

Eligibility Criteria:
Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* Current tobacco use or regular use within the last 2 years
* Current musculoskeletal injury
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
* Currently pregnant or breastfeeding, or planning to become pregnant during the study
* Inability to follow the rules of the protocols or understand the consent form
* Contraindications of consuming a core temperature monitoring pill
Parents at the Center: Information Management in ADHD - Clinical Trial

Health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. Parents of children with Attention Deficit/ Hyperactivity Disorder (ADHD) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. We propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. The research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on ADHD and the process-level events that result from parent-provider communication? The following specific aims organize the clinical study: proposal: 1) To assess the effect of health literacy on successful completion of parent-reported ADHD health information in both paper-based and PCHR formats, and, 2): To determine the association between health literacy and process-level outcomes for ADHD that stem from parent-provider exchange of information. The formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus PCHR) for ADHD-specific information. Primary care records for children of this cohort will be analyzed for the prior 12 month period. Both a retrospective examination of documented ADHD processes of care and a prospective evaluation of the utility of data from the PCHR will occur. Literacy level is a primary variable of interest throughout the evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Primary language of parent/guardian is English or Spanish
* Parent/guardian reports that child has been diagnosed with ADHD
* Current child age is between 5 years and 12 years
* Child in question resides with the parental subject primarily
* Parent/guardian reports that they are the primary caretaker of the child
* Parent/guardian reports that they are the person who communicates with the primary care provider
* Parent/guardian reports that child is currently taking medication for ADHD or has taken it within the last 3 months

Exclusion Criteria:

* Parent reports that child in question has been diagnosed with mental retardation, autism, pervasive developmental disorder, Aspergers, or bipolar disorder
Enhancing Exercise Training for Adults With COPD

This study aims to find a new way to get individuals living with COPD to become and stay active during and after an exercise intervention. In this study, individuals living with COPD will participate in an online exercise intervention. The exercises included in this intervention are based in individuals' activities of daily living. Additionally, during this intervention, individuals with COPD will participate in peer support sessions and will be taught and encouraged to discuss eight behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise. The goal of this study is to test out this new protocol and determine if it is feasible to recreate on a larger scale and if it is acceptable for the COPD community.


Eligibility Criteria:
Inclusion Criteria: Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis (any stage), be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, and speak English or French.

Exclusion Criteria: less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with COPD by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.
Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality.


Eligibility Criteria:
Inclusion Criteria:

* First or second intracytoplasmic sperm injection (ICSI) treatment
* BMI 18-32 kg/m²
* No previous ovarian hyperstimulation syndrome (OHSS)
* Regular menstrual cycle (cycle length 28 ± 3 days
* Less than 20 antral follicles evaluated by vaginal ultrasound
* S- Anti-Müller Hormone (AMH) 10 - 40 pmol/L
* has given informed consent
Acute Effects of Foam Rolling and Proprioceptive Neuromuscular Facilitation Stretching

The hamstring muscle is one of the key elements in rehabilitation programs and sports activities that enable the restoration of optimal muscle length. Decreased flexibility in the hamstring muscle may disrupt the biomechanics of the waist and pelvis, leading to low back pain or musculoskeletal disorders.

This study aims to investigate the acute effects of foam rolling and proprioceptive neuromuscular facilitation stretching during warm-up on muscle flexibility, strength, and pain threshold in amateur athletes. According to our research, there is no study in this field in the literature.

H1: There is a difference between the acute effects of foam rolling exercise and PNF stretching exercise on muscle flexibility during warm-up in amateur athletes.

H2: There is a difference between the effects of foam rolling and PNF stretching exercises used as warm-up exercises on muscle strength.

H3: Foam rolling and PNF stretching exercises applied to the Hamstring muscle as a warm-up exercise make a difference in the pain threshold of the lumbar region and Hamstring muscle.

Stretching techniques used in athletes are frequently and widely used due to many effects such as changing range of motion, comfortable movement maintenance, and removal. There is no consensus in the literature on which of the static, dynamic, and proprioceptive neuromuscular facilitation stretching techniques is most effective, as opposed to the types of stretching for flexibility. There is no clear benefit of different stretching techniques to muscle performance. Accordingly, in the literature, it is seen that proprioceptive neuromuscular facilitation stretching techniques show a greater increase in joint range of motion compared to other stretching techniques.

Recently, the use of foam rolling has become widely used in sports applications due to similar effects seen in stretching and the hypothesized presence of a curative effect on muscle performance. There is not enough research on the extent of foam rolling during warm-up exercises to increase flexibility and muscle strength.

The hamstring muscle is one of the key elements in harmonious programs and sports activities that ensure the restoration of optimal muscle length. The emergence of the output in the hamstring muscle may disrupt the biomechanics of the waist and pelvis, causing low back pain or musculoskeletal disorders.

This study aims to investigate the acute effects of foam rolling and proprioceptive neuromuscular facilitation stretching on muscle input, strength, and pain intensity during nutrition in amateur athletes.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-30
* Being an amateur athlete

Exclusion Criteria:

* Hypermobility
* History of hamstring injury in the last 6 months
* Diagnosed orthopedic problems
* Surgery in the lower extremity or spine
* Back pain
* Presence of systemic or neurological disorders