cyrilzakka/clinical-trials huggingface dataset:
Underwater Resection of Non-pedunculated Colorectal Lesions

The aim of this study is to compare the efficacy of underwater resection (polypectomy) versus conventional polypectomy techniques for small and large colorectal lesions identified during colonoscopy.

Conventional endoscopic resection of small and large (≥1cm) colorectal lesions is well established and performed with the colon fully distended with gas. Conventional polypectomy is effective, but the rate of incomplete resection is approximately 10%. Incomplete eradication of precancerous lesions contributes to interval colorectal cancer; therefore, alternative techniques for resection that safely and effectively increase the rate of complete resection are important. Underwater resection (UR) of benign colorectal lesions is a novel technique that utilizes the advantages of water aided endoscopic methods and may decrease the incomplete resection rate of small and large non-pedunculated lesions.

The investigators propose the hypothesis that small (6-9mm) and large (≥1cm) non-pedunculated neoplastic colorectal lesions resected by UR (partially distended, water filled lumen without submucosal fluid injection), will significantly decrease the incomplete resection rate (IRR) compared to conventional polypectomy performed in a gas distended lumen.

Small (6-9mm) and large (≥1cm) non-pedunculated benign neoplastic colorectal lesions identified during screening, surveillance, diagnostic or therapeutic colonoscopy will be randomized to conventional polypectomy (in a gas distended lumen with or without submucosal fluid injection) versus UR (partially distended, water filled lumen without submucosal injection) at the patient level. Small (6-9mm) lesions will be removed with a 9mm firm, thin wire cold snare and large (≥1cm) lesions will be removed by snare electrocautery. Efforts to remove lesions en bloc with a small rim of normal mucosa will be made, although some larger lesions (≥2cm) may require piecemeal resection. Submucosal fluid injection with a solution may be used with conventional techniques for large and/or flat lesions. Post-polypectomy incomplete resection rates will be assessed from 4 quadrant biopsies obtained around the resection site immediately post-resection.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old) male and female patients.
* Scheduled for outpatient colonoscopy.
* Patient able to provide informed consent.
* Benign, small (6-9mm) and large (≥1cm) non-pedunculated colorectal lesions.

Exclusion Criteria:

* Diminutive (≤5mm) and pedunculated polyps.
* Lesions suspected of harboring deep submucosal invasion.
* Patients who decline to participate or are unable to provide informed consent.
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.


Eligibility Criteria:
Inclusion Criteria:

* Be able and willing to provide written informed consent.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has a life expectancy of at least 3 months.
* Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).
* Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC.
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Has adequate organ function.

Exclusion Criteria:

* Has other malignancies within 5 years prior to enrollment.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has known active central nervous system (CNS) metastases.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has an active infection requiring systemic therapy.
* Has known active Hepatitis B or Hepatitis C.
* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
* Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
4. Patients those who are able to cooperate and complete the follow-up.
5. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.
Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue

Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.

Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.

A prospective cohort of consecutive patients underwent LSG was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described.

In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity according to IFSO guidelines

Exclusion Criteria:

* Gastric specimen with injury and/or electrocoagulation signs at serosa
* Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis)
Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems

Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.

Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up.

Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation.

Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence.

Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis.

The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis.

Primary objective:

Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours.

Secondary objectives:

* The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment.
* Instrument separation during instrumentation.

Eligibility Criteria:
Inclusion Criteria:

* - Medically free patients.
* Patients with symptomatic pulpitis in one of their mandibular molars.
* Patient's age ranges between 22 to 45 years with no sex predilection.
* Patients who can understand Numerical Analogue Scales (NRS).
* Patients able to sign informed consent.

Exclusion Criteria:

* - Patients having a systemic disorder.
* Presence of periapical lesion.
* Pregnant females.
* Patients who had taken analgesics during the last 12 hours preoperatively.
* Patients having active pain in more than one tooth.
* Non- educated patients.
Implementing Virtual Reality (VR) to Reduce Sedation

The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.


Eligibility Criteria:
INTERVENTION GROUP

Inclusion Criteria:

* Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
* Aged 21 to 65

Exclusion Criteria:

* Visual impairments such as blindness which would impair them from watching the entertainment videos.
* Patients with history of CAD,
* History of seizures,
* History of vertigo,
* History of allergy to plastic,
* ASAII or III,
* Patient with active GI bleed, having either melena or hematochezia.

CONTROL GROUP

Inclusion Criteria:

* Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
* Aged 21 to 65

Exclusion Criteria:

* Visual impairments such as blindness which would impair them from watching the entertainment videos
* Patients with history of CAD
* History of seizures
* History of vertigo
* History of allergy to plastic
* ASAII or III
* Patient with active GI bleed, having either melena or hematochezia
Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure

The main purpose of this study is to determine whether dietary nitrate supplementation via concentrated beetroot juice improves central and peripheral cardiovascular control and physical capacity in patients with systolic heart failure.

Chronic heart failure (CHF) is a leading cause of morbidity and mortality worldwide. Although affecting the heart at first, it is now recognized that disability is largely due to impaired cerebral and skeletal muscle blood flow and consequently microvascular oxygenation. Reduced muscle oxygenation compromises oxidative metabolism and thus contractile performance. Impaired cerebral oxygenation not only reduces motor output (thus exacerbating muscle fatigue) but also constitutes a predictor of cerebral ischemic events and an independent prognostic risk factor.

Reduced levels of the vasodilator nitric oxide (NO) contribute to impaired blood flow and oxygenation in CHF. Development of new effective therapeutic strategies is therefore crucial given that current pharmacological treatment has failed to abrogate oxygenation deficits in CHF patients. Emerging evidence shows that nitrate serves as an alternative source for NO and improves muscle blood flow and oxygenation in health. Another striking feature of nitrate is that it can improve muscle work efficiency, a tenet of physiology that was once considered immutable.

Objective: To investigate systematically the role of dietary nitrate supplementation on central and peripheral cardiovascular function in CHF patients.

Eligibility Criteria:
Inclusion Criteria:

- previous diagnosis of systolic heart failure (left ventricular ejection fraction \<40%) under optimized clinical treatment as judged by the accompanying physician.

Exclusion Criteria:

* hospital admission in the previous 6 weeks;
* exercise training program in the previous 6 months;
* nitrate therapy (e.g., isosorbide dinitrate);
* tabagism;
* any condition that could interfere with the ability to exercise;
* diagnosed psychiatric or cognitive disorders;
* type I insulin-dependent diabetes mellitus;
* excessively over-weight (BMI\>35kg/m²);
* other diagnosed cardiorespiratory disorders (e.g., chronic obstructive pulmonary disease, peripheral artery disease).
LARC Forward Contraceptive Counseling at MHCC

This prospective randomized controlled study will evaluate if Long Acting Reversible Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases overall LARC uptake within a community college population compared to LARC forward counseling and referral to a secondary clinic for LARC placement. The study will be conducted at Mount Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All groups will receive the same standardized contraceptive counseling ("LARC forward counseling") and participants will be able to choose between a LARC method and short-acting method of birth control.

The purpose of this study is to evaluate the benefit of an on-campus birth control counseling and services clinic. Currently there are no health services that provide access to birth control located on the Mount Hood Community College (MHCC) campus. We are offering a temporary 'Birth Control Resource Center' for eligible students. All forms of birth control in this study are FDA approved.

During the study participants will undergo counseling to choose the method of birth control that is right for them. This will include watching an informational video and having a discussion with study staff. If participants choose pills, the patch the ring, or a diaphragm and do not have any contraindications to this method, they will receive a prescription for this method to be filled at the pharmacy of their choice. If participants choose Depo-Provera (the shot), they will receive their first shot on the day of their visit and a prescription for repeat shots every 3 months. If participants choose to have an IUD or Implant as their method of birth control, they will be randomized to one of two groups. There is a 50% chance of having the intrauterine device (IUD) or Implant placed immediately after the counseling session and a 50% chance of receiving a list of local clinics that can place the device at a later time.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish-speaking women.
* 17-30 years of age.
* Currently enrolled in a 2-year certificate program at Mount Hood Community College.
* At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months).
* Do not desire pregnancy within the next 12 months.
* No contraindications to LARC according to the Center for Disease Control and Prevention medical eligibility criteria (CDC MEC)

Exclusion Criteria:

* Women who are not currently sexually active with men and who do not anticipate becoming sexually active with a male partner in the next 6 months.
* Women who have had a tubal ligation or other sterilization procedure.
* Women who desire pregnancy within the next 12 months.
* Women currently already using a LARC method for contraception.
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults

We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.


Eligibility Criteria:
Inclusion Criteria:

* 1. Males and females ages 40-60 years.
* 2. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)
* 3. Capable of providing informed consent.
* 4. COVID-19 negative and/or asymptomatic.
* 5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period
* 6. HbA1c: 5.7-6.4%

Exclusion Criteria:

* 1. Participant who does not/will not eat animal protein sources.
* 2. Allergy to wheat, soy, or common ingredients in plant-based protein products.
* 3. Body mass index \<25 kg/m2 or \>40 kg/m2.
* 4. Hemoglobin \<10g/dL at screening.
* 5. Platelets \<150,000/uL at screening.
* 6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
* 7. History of gastrointestinal bypass/reduction surgery.
* 8. Pregnant or lactating individuals.
* 9. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
* 10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
* 11. Currently using prescription blood thinning medications.
* 12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
* 13. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.
* 14. Unwilling to avoid using protein or amino-acid supplements during participation.
* 15. Unwilling to fast overnight.
* 16. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.
* 17. Currently receiving GIP-1 or GLP-1 therapy (excluding semaglutide, see below)
* 18. Participants on semaglutide for \<3 months or with less than one treatment dose (injection) every two weeks
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).


Eligibility Criteria:
Inclusion Criteria:

* Triple-negative breast cancer
* Older than 18 years old
* Have tumor resection surgery
* Sufficient organ function (marrow, heart, liver)

Exclusion Criteria:

* Other malignancy
* Other serious disease( marrow, heart, liver)
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants

This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of bupropion.

The study is being conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of ALXN1840 (perpetrator) on the single-dose bupropion (victim) kinetics in healthy male and female participants.

The study has a Screening Period (Day -28 to Day -2), two 11-day study periods (Day 1 to Day 11) with a minimum of 14 days between doses of bupropion, and an End of Study Visit (Day 15 ± 2 days) after Period 2 dosing. Participants will report to the clinical research unit on the day prior (Day -1) to both dosing periods. All participants will receive 1 treatment in each study period; treatment order will be defined based on randomization: Treatments A and B.

The time between dosing bupropion alone or in combination with ALXN1840 in each treatment sequence will be a minimum of 14 days.

The PK profile of ALXN1840 and bupropion will be determined by blood sampling following single dose administration.

Eligibility Criteria:
Inclusion Criteria:

* Adequate venous access in the left or right arm to allow the collection of blood samples.
* Body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared.
* Willing and able to follow protocol-specified contraception requirements.
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of/significant medical history.
* Clinically significant multiple or severe allergies.
* Lymphoma, leukemia, or any malignancy within 5 years.
* Breast cancer within the past 10 years.
* Serum creatinine \> upper limit of normal (ULN) of the reference range.
* Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> ULN.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* QTc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.
The Effect of Prior Learning on Treatment of Morpheme Errors

This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. Children will receive one-on-one behavioral treatment over a six week period. Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. The other half will start with a grammatical form they rarely use. The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.


Eligibility Criteria:
Inclusion Criteria:

* Native English speaking
* Passed a pure-tone hearing screening
* 4-6 years of age
* SPELT-P2 (language) test score of \< 87
* K-ABC-II Nonverbal Scale (cognition) test score of \>75
* Sufficient morpheme errors to serve as treatment and control targets
* Articulations skills sufficient to judge use of language targets
* Able to attend treatment daily

Exclusion Criteria:

* Parent report of other handicapping conditions
* Clinical signs of other disorders
* Enrolled in outside treatment