cyrilzakka/clinical-trials huggingface dataset:
Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \<30 kg/m2
* Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
* Pathological colorectal carcinoma
* Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
* ECOG score is 0-1
* ASA score is Ⅰ-Ⅲ
* Informed consent

Exclusion Criteria:

* Previous gastrointestinal surgery
* History of inflammatory bowel disease
* History of familial adenomatous polyposis（FAP）
* Pregnant woman or lactating woman
* Severe mental disease
* Intolerance of surgery for severe comorbidities
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
* Requirement of simultaneous surgery for other disease
Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)


Eligibility Criteria:
Inclusion criteria:

* IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
* IBS-C with less than 3 complete spontaneous bowel movements/week
* IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
* Subject able of and willing to comply with the protocol and to give their written informed consents

Exclusion criteria:

* History of chronic gastrointestinal disorders
* History of lactose intolerance
* History of gluten intolerance
* Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
* Eating disorders
* Pregnancy in progress
Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License

This study will test the effectiveness of a multimedia campaign to educate ethnic minority teens about the choice to become a designated organ donor on their first driver's license.

Less than a fourth of ethnic minority teens in the U.S. are a designated donor (DD) on their state-issued driver's license. Asian-American/Pacific Islander (AA/PI) adolescents in Hawaii are even less likely to be a DD or to have talked to their family about becoming an organ donor. Health education interventions for adolescents have demonstrated improvements in knowledge and intentions to be an organ donor; but, AA/PI teens are underrepresented in such studies. Nevertheless, whether changes in knowledge or intentions result in more organ donors is unclear, since previous studies have not included a concrete behavioral outcome such as the teen becoming a donor on their driver's license. This application will test, via a randomized clinical trial, the efficacy of an Interactive Multimedia Intervention (IMI) to increase the number of AA/PI adolescents who are a DD on their state issued driver's license, identification card, or organ donor card/donor registry. Teen groups will be recruited from the community (churches and high schools, n = 40 groups, 530 teens) and randomly assigned to either the intervention or a comparison condition on prevention of underage drinking of alcohol. The theoretically-derived intervention will include culturally sensitive messages and information about being a designated donor that will be delivered via a DVD, Email, text/instant messaging, and websites. The comparison condition includes materials (DVD) previously shown to increase awareness about laws restricting access to alcohol by teens. The primary outcome is objectively validated donor status on a teens' driver's license/state identification card (ID) or donor card after 12 months of intervention. A secondary outcome is the reported rate of family discussions about organ donation and knowledge/intentions about donation. We hypothesize the youth groups assigned to the intervention will have higher rates for family discussions and DD status, compared to groups in the comparison condition. We will also test whether psychosocial and cultural factors act as mediators of any change in teens' knowledge, attitudes \& stages of change to become a DD. After the randomized trial we will disseminate the intervention to Organ Procurement Organizations in Hawaii and other states, and track diffusion outcomes over a year. If IMI methods can increase the number of minority teens who become a DD on their driver's license by 10% this would translate to 500,000 more teenage designated donors in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* adolescent aged 14-19
* member of a school club, youth program or teen group
* read and speak English
* parent provides consent

Exclusion Criteria:

* plans to permanently move out of state
New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )

The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES


Eligibility Criteria:
Inclusion Criteria:

* In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included
* Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis
* Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm )
* IVUS available lesions
* Non-emergent conditions
* Patients confirmed about study enrollment and 9 month followup angiogram and IVUS

Exclusion Criteria:

Lesion \& Procedural exclusion criteria

* IVUS unavailable lesion
* Restenotic lesions following PCI of de novo lesion like as below;

  * left main lesions
  * BMS restenotic lesion
  * vein graft lesion
* Restenotic lesions following 2.25mm DES implantation
* Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)
* Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions)
* Patients with little possibility of performing follow-up angiogram and IVUS

General exclusion criteria

* Contraindication to anti-platelet agents \& Bleeding history within prior 3 months
* Prior history or current presentation of DES thrombosis
* Age over 80 years
* Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus, Everolimus
* Severe hepatic dysfunction (3 times normal reference values)
* Serum creatinine level over 2.0 mg/dL or end-stage renal diseases on dialysis
* LVEF less than 30%
* Pregnant women or women with potential childbearing
* An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 9 months
* Life expectancy 1 year
Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery

The goal of this clinical trial is to compare pain after surgery in patients undergoing Transurethral Resection of Prostate. The main question it aims to answer are: Intrathecal nalbuphine as an adjuvant to local anesthetic will better provide pain relief after TURP surgery.

Participants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.

This study aims to evaluate the efficacy and side effects of nalbuphine, with the goal of providing anesthesiologists with evidence-based guidance for selecting the most appropriate pharmacological agents for their patients.

Participants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for Transurethral Resection of Prostate under spinal anesthesia
* American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Allergy to study medications or hypersensitive to local anesthetics
* Contraindicated for neuraxial anesthesia
* Inability to self-report pain
* Chronic opioid used
Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fed State

Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fed State


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults

The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up). First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people. Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.


Eligibility Criteria:
Inclusion Criteria:

Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)

* Gender: 75 men - 75 women
* Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
* Marital status: 50 older people with partner - 100 older people without partner
* Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
* Migration background: 100 older people born in Belgium - 50 older people born elsewhere

Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)

* 75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
* 75 women, older than 70 years, widowed/divorced/never married, moved last 10 years

Exclusion Criteria:

* Current institutionalization
* Current hospitalization
Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to "wash" blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied.

Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions.

Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery.

Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.


Eligibility Criteria:
Inclusion Criteria:

1. age \< 18 years
2. surgical repair at URMC by the pediatric cardiac surgical team
3. informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.

Exclusion Criteria:

1. Age ≥18 years
2. inability to provide consent/assent; 3) subjects having "emergent" surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded
Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds

The purpose of this study is to assess the safety and efficacy of Micro/nanobubbles (MNB's) for the healing of acute and chronic wounds.

Oxygen delivery is one of the primary factors in wound healing. Micro/nanobubbles (MNBs) can be used to increase the oxygen dissolved in solution and increase oxygen delivery to a wound. The purpose of this research study is to determine if MNBs applied to a wound improve wound healing.

After being informed about the study and potential risks, all patients will need to provide written informed consent before being included in the study. The characteristics of the wound will be assessed and measurements will be taken before and after treatment. Depending on the patient's wound type, the patient will be treated with MNBs in saline gauze which will be applied to the wound daily (for acute wounds), or MNBs in negative pressure wound therapy with instillation (NPWTi) (for chronic wounds) which will be applied to the wound continuously throughout the day with the wound evaluated and sponge replaced every 3-5 days. This is consistent with the current standard of wound care with gauze or NPWTi. Tissue oxygenation using infrared technology and wound healing will be measured and results collected for analysis.

Participation will last approximately 2-4 weeks or the duration of the inpatient admission. If discharge from the hospital is earlier than 2 weeks, the treatment will be discontinued and results will be submitted for analysis.

Eligibility Criteria:
Inclusion Criteria:

* are above the age of 18.
* have traumatic, surgical, or chronic wounds.
* have radiotherapy related tissue injury.
* have thermal, chemical, and/or electrical burn injuries.
* have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and/or neuropathic skin ulcers.
* have acute ischemic wounds

Exclusion Criteria:

* have infected wounds.
* have wounds with exposed vital structures such as nerves, arteries, and/or veins.
* have wounds associated with malignancy.
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.

In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years
* Good overall health without medical history or medications that could interfere with the study conduct.
* Minimum of 6 teeth per quadrant.
* Absence of probing depths ≥4mm.

Exclusion Criteria:

* Allergy to CHX or to CPC.
* Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
* Any adverse medical background or long-term medications that could affect gingival conditions.
* Having taken antibiotics in the previous three months.
* Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
* Pregnancy or breastfeeding.
* Smokers of more than 5 cigarettes per day.
* Orthodontic appliances.
* Fixed or removable prostheses.
* Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).
* Severe dental crowding.
Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC

The objective of this project is to examine the clinical effectiveness of a mindfulness intervention on reducing depressive symptoms among socio-economically disadvantaged, racial/ethnic minority adults and explore factors related to implementation in a Federally Qualified Health Center (FQHC). This research will be used to develop a generalizable model for delivery of streamlined mental health interventions in community based settings that will be broadly disseminated and scalable to other populations. Black and Hispanic adults are more likely than those who are White to receive depression treatment in primary care, where antidepressants are the most commonly offered treatment. However, Black and Hispanic adults are less likely than Whites to find antidepressants acceptable. A mindfulness depression intervention provided within primary care may be more accessible and acceptable for low-income, racial/ethnic minority individuals, a severely underserved population. The investigators will conduct a randomized controlled trial to test the clinical effectiveness of a mindfulness intervention (M-Body) on reducing depressive symptoms, compared to usual care, among low-income racial/ethnic minority adults in a FQHC. The M-Body intervention is based on Mindfulness Based Stress Reduction and has been tailored for the FQHC setting and patient population. Adults (N=254) with depressive symptoms will be recruited from a FQHC in the Chicago, IL area that serves majority racial/ethnic minority individuals (90%) living at or below the poverty line (74%). Half of the patients will be randomized to the M-Body intervention arm where they will receive 8-weeks of mindfulness training led by FQHC staff and the other half will be randomized to usual care. Information on factors relevant to implementation of the intervention in the FQHC will be obtained by convening a series of workgroups and individual interviews with FQHC staff, executive leadership and community stakeholders. Specific Aims: 1) Determine the effectiveness of M-Body on reducing depressive symptoms compared to enhanced usual care for racial/ethnic minority adults in a FQHC; 2) Explore potential mediators (stress related biomarkers, mindfulness) and moderators (age, personal, social, environmental stressors) of the intervention's effect; 3) Conduct a broad assessment of organizational and individual agency factors related to preparation and implementation of the M-Body intervention in a FQHC using a mixed methods approach.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* mild to severe depressive symptoms (Patient Health Questionnaire-9, PHQ-9, total score ≥ 5)
* English speaking

Exclusion Criteria:

* PHQ-9 total score \<5
* past 30-day suicidal ideation
* current, regular practice of meditation (≥ 4 per week)
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
* Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) \>40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH \>40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH \>40 mIU/mL
* Age ≥40 years; ≥35 with bilateral oophorectomy
* Vaginal pH \>5.0
* Less than or equal to 5% superficial cells on vaginal wall cytologic smear
* Normal clinical breast exam or negative mammogram if ≥ 40 years of age
* Negative urine pregnancy test (non-hysterectomized and \<12 months amenorrhea)

Exclusion Criteria:

* Enrollment in Sponsor's Study PR-04409 or PR-05812
* Participation in clinical trial or use of investigational drug within 30 days prior to screening
* Known hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
* Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or \>50% angiographic narrowing of coronary artery
* Thrombophlebitis or thromboembolic disorder or history of
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Currently taking St. John's Wort
* Drug/alcohol addiction within past 2 years
* Treatment with anticoagulants (heparin or warfarin)
* Smoking ≥15 cigarettes/day