cyrilzakka/clinical-trials huggingface dataset:
IMRT Versus 3DCRT for Locally Advanced Rectal Cancer, Prospective Phase II Study.

The goal of this prospective phase II study was to determine whether personalized planning-based nCRT for LARC would indeed decrease small bowel dose, and whether selected plans, specifically prioritizing lower dose to small bowel, would result in lower rates of acute GI toxicity compared with previously reported rates.

The standard of care for locally advanced rectal cancer is neoadjuvant chemoradiotherapy. However, acute gastrointestinal (GI) toxicity is common. Some retrospective studies suggested that Intensity Modulated Radiation Therapy( IMRT) reduces acute bowel toxicity compere to 3D conformal radiotherapy (3DCRT).The aim of this prospective phase II study to determine whether the use of IMRT planning in neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer can decrease small bowel irradiation dose compared to commonly used 3D conformal techniques ,and the rate of acute GI toxicity.

Patients (pts) with clinical stage II-III rectal adenocarcinoma were enrolled in a prospective phase II study of preoperative chemoradiation. For each patient two radiation plans were performed: IMRT and 3DCRT. After comparing two DVH (dose volume histogram) plans for organs at risk (OARs), such as small bowel and bladder, pts were treated according to the plan with maximal critical organs sparing. All Patients received 45 Gy in 25 fractions to the rectum and draining lymph nodes, followed by boost to the tumor, with concurrent capecitabine or 5- Fluorouracil .Weekly follow up was performed to assess acute toxicity.

The investigators hypothesize that the use of IMRT in neoadjuvant chemoradiation for locally advanced rectal cancer may reduce the small bowel and bladder irradiated volume and consequently reduce acute toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced rectal adenocarcinoma
* Performance status of 0-2
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* Prior radiotherapy to pelvis
* Metastatic disease at diagnosis
Gastric Swab for Helicobacter Pylori Detection

A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.

The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20-80
* Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.

Exclusion Criteria:

* Surgical history of any kind of gastrectomy
* Patients with contraindication of esophagogastroduodenoscopy
CBT for Adolescents With Excessive Worry

This case series aims to test the feasibility and acceptability of streamlined cognitive behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses on reducing intolerance of uncertainty and the hypothesis is that this will help reduce worry.

This pilot study aims to test a new form of Cognitive Behavioral Therapy for adolescents with excessive worry. The investigators will include 12 participants with excessive worry and test the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce worry.

Participants will be randomized to either one, two or three weeks of weekly baseline measurements prior to starting treatment, and will thus work as their on controls in this case series design.

Primary outcome measures will be collected at 12 weeks after treatment start. Participants will be followed up at three months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* A score on PSWQ-C of at least 22
* Age between 13 and 17 years
* Ability to read and write in Swedish
* A parent or caregiver that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* Diagnosis of autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
* Present risk of suicide
* Ongoing substance dependence
* Occurrence of domestic violence
* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI

The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT measurement to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

The Octanoate Breath Test (OBT) developed by Exalenz is performed by the BreathID System consists of the BreathID device and a test kit containing a nasal cannula, a calibration gas container and a non-radioactive isotope ¹³C- Octanoate solution, and measures and computes the ratio between ¹³CO2 and 12CO2 in the patient's exhaled breath.

This study's aim is to provide data on this novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. It is hypothesized that in the future the OBT may have an impact on decision making and clinical practice in this group of HCC patients, allowing a greater chance for proper management and hence survival.

Eligibility Criteria:
Inclusion Criteria:

* Any patients with chronic liver disease at risk for HCC.
* Age \> 18 years.
* Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
* Patient is naïve to any HCC treatment.

Exclusion Criteria:

* Underwent any RFA or TACE or Oral HCC treatments.
* Portal vein thrombosis.
* Prior TIPS placement.
* Severe congestive heart failure (LVEF on echocardiogram \< 20%).
* Severe pulmonary hypertension (By echocardiogram, PAS \>45 mmHg).
* Uncontrolled diabetes mellitus (HBA1C \>9.5%).
* Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
* Previous surgical bypass surgery for morbid obesity (BMI \>45).
* Extensive small bowel resection.
* Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
* Women who are pregnant or breast feeding.
* Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
* Patient has taken drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
* Patient, based on the opinion of the investigator, should not be enrolled into this study.
* Patient is unable or unwilling to sign informed consent.
* Patients that are participating in other clinical trials evaluating experimental treatments or procedures
SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity

Obesity is closely associated with an increased risk of cardiomyopathy because of the high metabolic activity of excessive fat while effective treatment of obesity-related cardiomyopathy is currently unsolved. Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a class of diabetic medications. Besides improving glucose control, SGLT2-i has been shown to be able to reduce the bodyweight as well as the mortality and hospitalization rates for heart failure and cardiovascular disease in the type 2 diabetes patients. It has been proposed that the heart protection by SGLT2-i might be caused by modulating the production of adipokine and cytokine. The investigators will enrolled 40 patients (diabetes mellitus with BMI\>27 Kg/m2) from obesity weight-reduction clinics: 1) 20 patients treated with SGLT2-i (CANA) and regular weight-reduction plan; 2) 20 patients with regular weight reduction plan, without CANA, for 4 weeks. The investigators will compare the variation of Fibroblast growth factor-21 (FGF21) related proteins and RNA between these 2 groups of subjects. The investigators will arrange cardiac ultrasound, hepatic MRI and fibroscan, body composition dual energy x-ray absorptiometry to evaluate the possible mechanisms underlying the liver and heart modification process, as a scientific basis for precision medicine in the future. Conclusions: SGLT2-i treatment may increase the concentration of FGF21, either in the liver or heart, thus to protect the high-fat diet induced obesity associated heart dysfunction by activating FGF21 downstream protein expression.

The investigators will enrolled 40 diabetes mellitus with BMI\>27 Kg/m2 patients from obesity weight-reduction clinics and will compare the variation of FGF21 related proteins between these 2 groups of subjects. Serial examinations will evaluate the possible mechanisms underlying the protective mechanism. This investigation expect that SGLT2-inhibitor can increase the concentration of FGF21 in the heart by increasing FGF21 in the liver, thereby modifying associated protein expressions and ultimately improving cardiac function and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 20 years of age
2. With diagnosis of diabetic mellitus (HbA1C≧6.5%) by medical record or physicians
3. BMI ≧ 27 kg/m2, which is the current definition of obesity from Health Promotion Administration, Ministry of Health and Welfare.

Exclusion Criteria:

1. Unwilling to participating current clinical trial
2. Cannot tolerate SGLT2-i therapy
3. Not willing to join the study
4. History of failure treatment experience from SGLT2-i or other weight reduction plan
5. Received pharmaceutical or clinical trials within past 1 year
A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)

In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.


Eligibility Criteria:
Inclusion Criteria:

* being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
* interested in having him quit ST use
* willing to provide a phone number, mailing address, and e-mail address
* provides informed consent
* the woman and the chewer are both U.S. or Canadian residents age 18 or older
* the woman and the chewer are both able to read English
* the woman and the chewer are both able to access a computer

Exclusion Criteria:

* none
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).

This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system, a new and novel method of fistula creation, which uses a percutaneous method to create an AVF. Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula (AVF) creation will be enrolled using the WaveLinQ device. Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure. Subjects who are eligible will undergo fistula creation per standard institutional technique (index/baseline) and be followed at least monthly for 6 months per their standard of care plan. Primary, clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol. The expected total duration of subject participation from screening until the end of study is up to 7 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female Age of at least 18 years
2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.
4. Currently not on hemodialysis.
5. Life expectancy of at least one year
6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
7. Willing to comply with the specified follow-up evaluations

Exclusion Criteria:

1. Anatomical exclusion criteria met
2. Thought to need dialysis within 30 days.
3. The subject is in a hypercoagulable state.
4. The subject has known bleeding diathesis.
5. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
6. Known history of active intravenous drug abuse.
7. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
8. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
9. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players

Nutrition interventions may present a safe and relatively risk free intervention for protection against subconcussive impacts. Docosahexaenoic acid (DHA, 22:6n-3) is the principal Omega 3 polyunsaturated fatty acid in the brain, playing an integral role in the brain's development and structural integrity. The goal of this study is to determine if supplementation with DHA attenuates blood biomarkers of repetitive head trauma linked to sub-concussive impacts sustained in rugby participation.


Eligibility Criteria:
Inclusion Criteria:

* Canadian national rugby athletes on 7s and 15s teams

Exclusion Criteria:

* None
Optimizing Postoperative Nutrition in Colorectal Surgery

Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal resection surgery
* Open or laparoscopic procedures
* Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection
* Elective or emergent procedures
* Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia
* Small bowel resection combined with colorectal resection
* Age \> 18 years old
* Informed consent

Exclusion Criteria:

* Small bowel resection without colorectal resection
* End-stoma or defunctioning stoma formation without colorectal resection
* Preoperative parenteral nutrition administration
* Administration of parenteral nutrition after the 4th postoperative day
* Peripheral parenteral nutrition initiation after the 1st postoperative day
* Contraindication for peripheral parenteral nutrition administration
* Age \< 18 years old
* No informed consent
Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement

The aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.

Virtual reality application, which is a non-pharmacological application; It is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. Virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . As a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. Explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application.

Eligibility Criteria:
Inclusion Criteria:

* The research included people between the ages of 40-75,
* Volunteering to participate in the research,
* Being able to understand and speak Turkish,
* Being able to understand the verbal, written and video explanations given,
* Having no problems communicating cognitively, affectively and verbally,
* Not having any obstacle to using virtual reality glasses,
* Patients who underwent unilateral TKA surgery,
* Using the SPH device at the same degree for three postoperative days after the FFP operation.
* Having the surgeon's permission

Exclusion Criteria:

* Patients who will undergo revision TDP surgery,
* Those who have a neurological disease that causes functional disability,
* Those with a diagnosed psychiatric disorder,
* Refusing to take the SPH device after the operation or taking it to a different degree,
* Those who have a condition that prevents them from wearing virtual glasses for any reason,
* These are patients after the FFP operation and outside the third postoperative day.
Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.

Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.

Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.

The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-85 years undergoing primary and isolated on-pump CABG
* Last ingestion of clopidogrel and aspirin within 7 days preoperatively

Exclusion Criteria:

* Previous cardiac surgery
* Hematocrit \<33%
* Platelet count \<100,000/ml
* Allergy to tranexamic acid
* Recruited in other studies
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain

evaluation of core muscles endurance and strength following backward walking training programe

A randomized controlled trial will be conducted at the Isokinetic laboratory, Faculty of Physical Therapy, Cairo University, to investigate the effect of backward walking training on core muscles strength and endurance, pain severity, and disability level in subjects with NSLBP. Sixty females clinically diagnosed with nonspecific low back pain with age range from 18-45 years will participate in the study. They will be randomly assigned into 3 groups according to the received intervention; backward walking group (BWG), core stability group (CSG), and control group (CG). The isokinetic strength of trunk muscles, and hip extensors and abductors will be evaluated in a concentric mode of muscle contraction. McGill's core endurance tests will be used to examine participants' core endurance. The visual analog scale will be used for measuring the pain intensity. The oswestry disability index will be used to assess pain related disability and quality of life in subjects with LBP.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be included if they have a history of LBP for more than 6 weeks before the study, or experienced at least 3 episodes of LBP each lasting more than one week, during the year before the study.

Exclusion Criteria:

* Participants will be excluded if they have:

  1. LBP as a result of a specific spinal condition (e.g. spondylolisthesis, or spinal stenosis).
  2. Previous abdominal or spinal surgery.
  3. Serious spinal conditions (e.g., vertebral fracture, tumor or infection).
  4. Severe musculoskeletal deformity (scoliosis or kyphosis).
  5. Inflammatory disorders (e.g. Rheumatoid arthritis).
  6. Radicular symptoms consistent with a disc herniation, or cauda equina syndrome.
  7. Pain and dysfunction in the upper and lower extremity that would interfere with testing.
  8. Current pregnancy.
  9. Marked leg length discrepancy greater than 2 cm.