cyrilzakka/clinical-trials huggingface dataset:
Mesenteric Vessel Sealing by Three Instruments

Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic energy to cut through and coagulate tissue. An Ethicon version (trademarked "Harmonic Scalpel" and "Ultracision") is used in a variety of surgical procedures. Its surgical performance has been directly compared with that of electrically powered diathermy instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon, which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel. There are also bipolar feedback diathermy instruments which use electrical energy to seal blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure bipolar device reliably seal and divide blood vessels? The investigators will also be examining the degree of collateral tissue damage caused by each instrument.

Hypotheses

* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing mesenteric blood vessels.
* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral damage when sealing and dividing blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing laparoscopic or open colorectal resection

Exclusion Criteria:

* Pregnant or lactating women
* Patients under eighteen years of age
* History of coagulation abnormality
* Inability to understand the nature of the study
Remote Mindfulness Education PLV

This is a study designed to learn more about the use of an online remote education and mindfulness practice program for the pain and anxiety associated with provoked localized vulvodynia.

The purpose of study is to evaluate the effectiveness of a remotely delivered mindfulness intervention combined with education for the treatment of the pain and distress associated with Provoked Localized Vulvodynia (PLV). Women with PLV will be randomized to either an app- based mindfulness program (Headspace®) with online education or online education only. Pain and sexual distress with be evaluated through a number of measures. The primary outcome of the study will be the change in distress relating to sexual activity over the 8-week intervention period, which will be measured by a change (reduction) in the Female Sexual Distress Scale (FSDS). Participants will additionally perform a weekly Tampon Test and fill out a weekly survey regarding their perceived pain as well as the frequency of use and completion of the weekly education materials

Eligibility Criteria:
Inclusion Criteria:

* Reported dyspareunia for at least 3 months in non-pregnant, healthy women over aged 18 years old and estrogen replete with confirmed diagnosis of provoked localized vulvodynia (PVL) or positive Q-tip test, meeting Friedrich's criteria for PLV.
* Ability to insert a regular Tampax® tampon
* Phone access
* Cellular phone with ability to download applications
* Reliable Internet Access

Exclusion Criteria:

* Pregnancy
* Active sexual counseling or mindfulness training (within 6 months of study)
* Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc).
* Unable or unwilling to complete baseline assessments or agree to be randomized.
* Non-English speaking, as Headspace® is not validated in other languages
* Actively engaged in a meditative practice
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* male over the age of 18 years
* present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
* subjects must read, understand and sign the Informed Consent
* AUA ≥ 15
* Qmax \< 15mL/sec
* Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
* Prostate volume ≥ 30g

Exclusion Criteria:

* PVR \> 300ml
* Current urine retention
* Previous surgical or invasive treatments (TURP, TUMT, TUNA)
* PSA ≥ 4 (must have negative biopsy within last 12 months)
* Neurogenic bladder
* Obstruction due to urethral stricture
* Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study
The SOURT OUT IV TRIAL

In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.

2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease.

2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months.

2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion Criteria:

* The patient will not participate
* The patient participates in other randomised stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578
What Happens to First Trimester Nuchal Translucency

First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites\> = 99th p but \<3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group\> = 99th p and \<3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.


Eligibility Criteria:
Inclusion criteria:

nuchal translucency\> = 99th percentile

Exclusion criteria:

- multiple pregnancies
Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

Primary objective:

• Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration.

Secondary objectives:

* Define the pharmacokinetic parameters of Temozolomide Oral Suspension.
* Assess the buccal safety of Temozolomide Oral Suspension.

The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed glioblastoma multiforme treated with temozolomide (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma treated with temozolomide as monotherapy (200mg/m2).
* Male and female patients at least 18 of age.
* Non-pregnant, non-breast feeding female.
* Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².
* Having given a written informed consent

Exclusion Criteria:

* Co-administration of sodium valproate
* Patients with (naso)gastric tubes
* Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)

This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.

Patients with an initial episode of CDI will be followed up for CDI recurrence or sustained clinical response. The subjects will be allocated into 2 groups at the study end:

* Recurrence Group: Subjects who experience recurrence of CDI after clinical response to antibiotic treatment to treat the initial CDI episode.
* Sustained response Group: Subjects who do not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.

This protocol has been amended twice to improve recruitment of subjects in the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol or/ and subjects who can receive assistance from his/ her legally acceptable representative (LAR) or a designate who can and will comply with the requirements of the protocol.
* A male or female aged 18 years or older at the time of enrolment.
* Written informed consent obtained from the subject/ LAR of the subject.
* A reasonable prognosis of survival during the study period as judged by the investigator.
* Outpatients, emergency room and/ or hospitalized subjects diagnosed with CDI for which the symptoms started maximum 14 days prior to study enrolment.
* Subjects who receive or plan to receive antibiotic treatment to treat the CDI episode.

Exclusion Criteria:

* Concurrently participating or planning to participate in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous CDI episode within the previous 6 months before study enrolment (except for up to \~25% of the subjects).
* Chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease.
* Planned surgery for CDI within 24 hours after study entry.
* Previous vaccination against Clostridium difficile.
* Having received a Clostridium difficile monoclonal antibody product(s) within the previous 3 months or planned administration during the study period.
* Administration of immunoglobulins within the previous 3 months or planned administration during the study period.
* Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the results of the study.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the previous 6 months.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
* Family history of congenital or hereditary immunodeficiency.
* Major congenital defects.
Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms

In this study, potential associations between several genetic polymorphisms and nicotine dependence will be examined. The relative reinforcing efficacy of cigarettes using the forced-choice procedure will be assessed. In addition, reactivity to smoking cues using a reliable procedure will be conducted.

It is known that cannabinoid and dopamine receptors can be important modulators of response to nicotine and its associated cues. In this study participants will be genotyped to determine whether there is a relationship between CB1 or D3 genes and the reinforcing properties of nicotine or the subjective effects of nicotine-associated cues. In one session, participants will chose between two different cigarettes, each with different properties. In another session, physiological responses and craving will be measured when presented with cues that remind participants of nicotine. At some point during the study, blood will be collected for genotyping and this will processed to study whether CB1 or D3 genotype influences these responses to nicotine or cues.

Eligibility Criteria:
Inclusion Criteria:

1. 19-64 year old males and females
2. smoking at least 10 cigarettes per day for at least 1 year
3. positive urinary cotinine
4. medically and psychologically healthy as determined by screening criteria

Exclusion Criteria:

1. definite plan to reduce or quit tobacco use during the course of the study
2. treatment for tobacco dependence in the past 3 months
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. consumption of more than 15 alcoholic drinks per week during the past month
5. use of any illicit drug more than twice per week during the past month
6. current use of any medication that would interfere with the protocol in the opinion of PI
7. under the influence of a drug or alcohol at any session
8. pregnant, nursing, or become pregnant during the study
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Eligibility Criteria:
Primary Inclusion Criteria:

1. Outpatient men and women at least 18 years of age.
2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

1. Treatment with DVS SR at any time in the past.
2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Dexamethasone in Total Knee Arthroplasty

The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

Study design: Prospective randomized controlled trial

Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.

Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Primary total knee arthroplasty
* Patients staying at least one night in the hospital after surgery

Exclusion Criteria:

* Same day discharge Age \< 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal
The Impact of Food on Blood Sugar in People With Type 2 Diabetes

This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).

The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.


Eligibility Criteria:
Inclusion Criteria:

* Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.

Exclusion Criteria:

* Study participants who are unable to complete the baseline CGM data collection at week -2-0.
* Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
ADC in Assessing Femoral Tunnel Position

To examine the consistency between postoperative CT scan and intraoperative arthroscopic measurement in evaluating femoral tunnel position for anterior cruciate ligament （ACL）reconstruction，both using the apex of the deep cartilage（ADC）as the marker.

The position of the center of femoral tunnel was decided in the complete femoral stub. Then the length from the ADC to the anterior cartilage margin（L1）and to the center of femoral tunnel（l1），as well as the center to the distal cartilage margin（D1）were measured under arthroscopy and on post-operative CT scan（L2，l2 and D2）. Moreover，P1 and P2 were calculated through l1/L1 and l2/L2.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 who need anterior cruciate ligament reconstruction

Exclusion Criteria:

* Volunteers unsuitable for anterior cruciate ligament reconstruction
Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion

The main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ETT) 180 degrees prior to intubation will decrease the incidence of postoperative throat soreness, when compared to standard technique used in Standard of Care.

The researcher who is not blinded will randomize the patient to one of the three groups.

Specific technique and procedure:

* Investigators anesthesiologists assigned to perform the laryngoscopies will be limited to 6 with minimum 2 years of attending experiences to balance the variability. The results of inter-operator bias will be analyzed.
* Endotracheal Tube (ETT) size will be: 7.0 for men and women unless there will be clinical indications to use a different size of Endotracheal Tube.
* Stylet preparation: 75-degree angulation shaped preoperatively and ready for use
* Blade for either McGrath, Macintosh, or direct laryngoscopy will be size 3 for women and size 4 for men.
* Endotracheal Tube (ETT) 180: inserting endotracheal tube loaded with stylet, rotating the tube 180 degree clockwise as soon as the tube tip passes the vocal cords (glottis), and removing the stylet after the tube cuff passes through the vocal cords, which is a common practice.
* Endotracheal Tube cuff filling air pressure will be 20 cmH2O. Inflation will be made using a hand-held airway pressure manometer.
* Patient's data collection will be blinded for both patient and Investigators anesthesiologists assigned to perform the laryngoscopies
* No medications including opiates, monitoring options, and medical decisions will be altered by the study.

A member of the research team will follow-up (in person or phone-call) with each patient in the Post Anesthesia Care Unit (PACU) and 24+/- 3 hours after endotracheal tube removal to collect information regarding any symptoms of hoarseness or sore throat.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - III
* Ambulatory patients undergoing general anesthesia with an Endotracheal Tube (ETT) placement
* Admitted patients undergoing general anesthesia an Endotracheal Tube (ETT) placement
* Age \> 18 and \< 90 years old
* BMI \< 50

Exclusion criteria:

* Age \< 18 years old or age \> 90 years old
* Pregnant women
* Prisoners
* Any surgery involving the pharynx, larynx, vocal cords, trachea that will create confounding factors related to postoperative sore throat
* History of difficult airway
* Critically ill patients requiring intensive care