cyrilzakka/clinical-trials huggingface dataset:
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications

In all thyroid surgeries, many surgeons utilize drains on a regular basis and have done so for years according to recommendations. Due to the thyroid's high vascularization throughout its endocrine function, any haemorrhage inside the closed paratracheal space has the potential to impede venous and lymphatic drainage, which might result in airway blockage and laryngopharyngeal oedema. Surgeons routinely perform post-operative thyroid gland draining in the modern surgical field. The goal is to stop fluid from accumulating in the surgical wound site, which could constrict the patient's trachea and jeopardize their life.

Thyroid storm, hypocalcemia, hematoma/haemorrhage impairing airway, recurrent or superior laryngeal nerve damage, and wound problems such as wound infection are among the main post-operative consequences of thyroid surgery.

Some reports indicate the use of drains following thyroid surgery is not very beneficial. Some researchers have been prompted by this to consider whether drains should be inserted during thyroid surgery in which several research papers and meta-analyses have also failed to demonstrate the benefit of drainage in thyroid surgery. Blood clots in the drains could cause severe post-operative bleeding, preventing the surgeon from being notified. Difficult thyroidectomy cases might be predicted by factors linked to the patient, the thyroid, or the surgeon.

When thyroidectomies are performed under ideal conditions-that is, in a setting where good anatomical and physiological expertise is matched with meticulous surgical skills-complications are rare. The ability of the surgeon to do a thyroid surgery without difficulties is crucial. It is not possible to see routine drain use as a substitute for these components.

Percutaneous drains are frequently used in head and neck surgery cases. However, although effective at preventing post-operative haematoma formation, their use can also be associated with significant complications, including infection, fistulae, pain, psychosocial implications and most notably, prolongation of hospital stay.

Accordingly, some researchers that reject the use of intraoperative drains, there isn't a very high rate of wound hemorrhages following thyroid surgery. Additionally, other research indicates that there is no difference in the two groups' incidence of post-operative problems with and without drainage.

Nearly all surgeons utilize a closed vacuum drain after the intervention to avoid the deadliest complication, a smothering haemorrhage, which several studies suggest may not be essential


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years.
* Both sexes.
* Unilateral \\ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy.

Exclusion Criteria:

* Surgical contraindications such as coagulation dysfunction.
* Retrosternal goiter.
* A history of cervical surgery.
* Sever Co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease).
* Malignancy.
Tocilizumab for the Treatment of Refractory Behcet's Uveitis

The aim of this single-center prospective study is to evaluate the efficacy and safety of Tocilizumab (TCZ), humanized monoclonal antibody against IL-6receptor, in the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on decreasing the dose of cortical steroids, and to determine whether it can reduce BDU recurrence.

Uveitis of Behçet's disease (BDU) is the most common form of ocular manifestations, which is also the leading cause of irreversible visual impairment. The aim of the study is to Improve treatment strategy of the disease as well as to reduce blindness.

Tocilizumab (TCZ) is a humanized antibody against IL-6 receptor, clinical trials on non-infectious uveitis and retrospective study on BDU has obtained expected results.

This single-center prospective study is to evaluate the efficacy and safety of TCZ in the treatment of refractory BDU, to verify its effects on decreasing the dose of corticosteroids, and to determine whether it can reduce BDU recurrence.The investigators aim to enroll nine refractory BDU patients with acute onset uveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants. All participants will receive TCZ , oral corticosteroids and immunosuppressants will remain unchanged, intraocular injection will be avoided. During monthly follow-up, the investigators will measure and record intraocular inflammation status，as well as extraocular manifestations and the acute-phase reactants. The participants will continue to receive TCZ for six months, the primary end point is the efficacy four weeks after first dose of TCZ, secondary end points other than intraocular inflammation will be achieved on each follow-up visit, as quality of life improvements, side effects, recurrence of uveitis, and corticosteroids-tapering effects.

On statistical analysis, the self-control treatment efficiency and recurrence rate difference will be determined using T-test of paired samples at a significance level of 0.05(2-sided).

To ensure the interest of the participants, the study has been reviewed by the PUMCH ethics committee, and drug clinical research liability insurance was prepared.

Eligibility Criteria:
Inclusion Criteria:

* All participants fulfill the the proposed International Criteria for BD, either ISG criteria(1990) or ICBD criteria(2013).
* All participants present with refractory BDU , acute onset uveitis, either posterior segment involvement or panuveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants, without severe extraocular manifestations.

Exclusion Criteria:

* Patients with impaired hepatic and renal function, other severe ocular diseases, active tuberculosis, viral hepatitis, malignancy, pregnancy will be excluded.
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 When Given Together With Chemotherapy and the Effectiveness of This Combination Treatment in Shrinking a Specific Type of Lung Tumors (Small Cell Lung Cancer)

This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged \>/=18 years
* Histologically or cytologically confirmed, extensive disease SCLC
* At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1. Subjects with non-measurable disease according to RECIST 1.1 can be included in the Phase Ib part of the study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Life expectancy of at least 12 weeks
* Serum sodium \>/=130 mmol/L

Exclusion Criteria:

* Prior systemic anticancer therapy
* Prior radiotherapy (local palliative radiotherapy is permitted)
* History of cardiac disease: congestive heart failure \> NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
* Moderate or severe hepatic impairment, ie Child-Pugh class B or C
* Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.

65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics, family planning clinics, postnatal clinics, community based organizations and community outreach in Chiang Rai, Thailand.

Our study objectives are:

* To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
* To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
* To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
* To evaluate the association of genital symptoms and HIV or HSV genital shedding.
* To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Eligibility Criteria:
Inclusion Criteria:

* participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

* pregnancy, CD4 count \<200, on ART
Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest

Previous studies reported that the introduction of the role of the CPR Coach in resuscitation teams led to an increase in the adherence of CPR to AHA guidelines by the team.

To date, the interaction between the CPR Coach and the Team Leader during the performance of CPR remains poorly studied.

In this study, the investigators aim to evaluate whether the interaction between the CPR Coach and the Team Leader brings real benefits to the cognitive engagement of the latter and therefore whether or not his leadership and the overall performance of the team is affected.

In this study, 60 trainees will be divided into 10 teams of 6 participants each, which include two CPR providers, a team leader, a nurse actor, a defibrillator actor with (study groups A and B) or without (control group, C) a coach.

Each team will perform a standardized 10-minute cardiopulmonary resuscitation (CPR) simulation on a standardized Trauma Hal mannequin (Gaumard Scientific) with a Combat Application Tourniquet (CAT Resources, Rock Hill, SC)/SUSIE simulator(Gaumard Scientific, Miami, FL) with a CPR Feedback device. All participants assigned the role of the coach will receive standardized training as described by Cheng et al, 2018.

Study group A will run the simulation with the CPR coach figure standing next to the defibrillator; study group B will run the simulation with the CPR coach free to move around the scenario; control group C will run the simulation without the CPR coach. During the simulations, an experienced facilitator and a simulation technician will be present to conduct and oversee the progress of the activities.

All activities of all teams will be recorded with cameras and microphones. At the end of each simulation, there will be a debriefing conducted by an expert facilitator to make the simulation experience complete but will not be considered in the study.

All recorded videos will be viewed by 4 experts who will score the leader's performance and the team's performance. The leader's performance will be evaluated by using the Resuscitation Team Leader Evaluation Scale (RTLE) (Grant et al,2012). The Team's overall performance will be evaluated by the Clinical Performance Toll (CPT)(Donoghue et al, 2010).

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia trainees
* Emergency medicine trainees

Exclusion Criteria:

* none
The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation

the purpose of this experiment is to determine if acute melatonin supplementation alters central and peripheral cardiovascular responses to a cold pressor test at rest and during dynamic exercise.

After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the University of Oklahoma Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once consented and enrolled, participants will be familiarized with experimental protocols. On separate days (visits 2 and 3), participants will complete placebo (PLA) and melatonin (MEL) in a randomly ordered, single-blind, counter-balanced design. PLA or MEL treatment will precede testing by 30min to maximize absorption into the circulation (Bartoli, 2013).

All experiments (PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by activation of the lower body negative pressure (LBNP) device causing suction at -20 mmHg. Following LBNP participants will be given 10 minutes of rest to recover all variables to pre-LBNP values. After which participants will be given a hand grip dynamometer to complete 7 minutes of exercise at an intensity of 20% MVC at a 1s contraction to 2s relaxation cycle paced by a metronome. During the final 2 minutes of the 7 minutes of exercise the LBNP device will be activated again to -20mmHg such that the participant will be completing LBNP during rhythmic grip exercise. After the completion of exercise, the subject will remain supine for 10min. Then the a Total Labile Signal (TLS) procedure will be conducted. Where the experimental limb is occluded using a blood pressure cuff for 5min. The cuff is then rapidly deflated. The lowest oxyhemoglobin measured during the occlusion is recorded. After the TLS procedure, the subject will be de-instrumented and will leave the laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Women must be premenopausal with a regular menstrual cycle (26-30 days)

Exclusion Criteria:

* History of autonomic dysfunction
* Cardiovascular diseases
* Diabetes
* Tobacco/nicotine use
* Systolic Pressure \>= 130 mmHg
* Diastolic Pressure \>= 85 mmHg
* Regular melatonin use \>= 1 use/week
* Allergy to melatonin
* Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins)
* Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone)
* Pregnancy
A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection

The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Clinical indication for a therapeutic liver resection
* BMI of 25 kg/m2 or greater
* Informed Consent

Exclusion Criteria:

* Inability to comply with the pre-op diet
* Patients who have lost 5% or more of their usual body weight over the preceding one month
* Female patients of childbearing age who have a positive pregnancy test
Dietary Guide in Active Older Adult Men

The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Background and Aim: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Materials and Methods: Participants included sedentary men (age 45-75 years) with overweight or obesity (n=37). They were randomly divided into 2 groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 37 participants, 30 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.

Exclusion Criteria:

History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Same as above

Eligibility Criteria:
Inclusion Criteria:

* Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.

Exclusion Criteria:

* Age less then 18
* Known sensitivity to Bacitracin
* Pregnancy
Distinguishing Acetabulum Cup Retroversion From Anteversion on Anteroposterior Radiographs After Total Hip Arthroplasty

In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.

Total hip arthroplasty (THA) is considered to be the best and most reliable treatment of end-stage hip disorders with satisfactory long-term clinical outcomes. However,the incidence of postoperative dislocation ranges from 0.3% to 3% in primary THA. The most important risk factor is malpositioning of implant components. Generally, excessive anteversion and retroversion increase risk of anterior and posterior hip dislocation respectively. Several radiological methods have been proposed to measure anteversion of the acetabular cup on plain radiographs, but most of these methods cannot accurately distinguish cup retroversion from anteversion. In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone total hip arthroplasty
* Patients undergone total hip arthroplasty with more than two postoperative anteroposterior radiographs of pelvis
* Patients undergone total hip arthroplasty with postoperative pelvic CT

Exclusion Criteria:

* Patients with congenital pelvis abnormality or pelvic fracture history
* Patients with postoperative periprosthetic fracture(s)
* Patients with postoperative infection or implants loosening
* Patients undergone total hip arthroplasty without more than two postoperative anteroposterior radiographs of pelvis
* Patients undergone total hip arthroplasty without postoperative pelvic CT
Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight

Excessive body weight is becoming a concern around the world, for example over half of the American adult population is overweight or obese. The purpose of this study is to determine whether dietary supplements and shakes containing a combination of nutrients/ingredients individually shown in research studies to reduce hunger, enhance metabolism, reduce the body's ability to 'store' fat, and enhance energy, promote healthy body weight and composition over 12 weeks. A further study objective is to determine whether the inclusion of a personal, easy to use, energy tracking device for the measurement of daily energy intake and expenditure also helps with the promotion of healthy body weight and body composition.

In this prospective, blinded study 120 volunteers who meet the entrance criteria including a BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil supplement. Subjects will be randomly assigned to a control or experimental group and stratified by BMI 25-30 and \>30-35 kg/m2, age, and gender with an equal number of subjects in each strata across groups. A subset of subjects will also wear a personal energy tracking device. Subjects will be instructed how to incorporate the shakes and supplements into their current diet and encouraged to incorporate fruits, vegetables, whole grains, and other healthy foods into their current meals and to exercise at least 30 minutes five days per week.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65 years of age.
* Body Mass Index (BMI) between 25-35
* Willing to stop taking any nutritional supplements

Exclusion Criteria:

* Currently taking weight loss medication or supplements
* Currently smoke
* Taking any prescription medications
* Experienced at least a 10 pound weight loss over the past 2 months.
* History of serious heart problems (i.e. heart attack, angina, bypass surgery).
* Diagnosed with diabetes (insulin or non-insulin dependent)
* Known history of gastrointestinal diseases (i.e. Crohn's disease, chronic diarrhea, Inflammatory Bowel Disease)
* Undergone surgical procedure for weight loss (i.e. gastroplasty, gastric by-pass, gastrectomy, stomach stapling, gastric banding, etc).
* History of stroke or seizure activity
* Medical conditions known to affect serum lipids
* History of uncontrolled hypertension or with a current measured blood pressure with diastolic above 90 or systolic above 140 mm Hg
* A total serum cholesterol above 240 mg/dL
* Known HIV infection
* Known history of depression and currently taking anti-depression medications
* Treated for cancer in the last 5 years
* Known allergies to supplements
* Known history of eating disorder (i.e. bulimia, anorexia nervosa)
* Known severe swallowing disorders
* For females, known to be pregnant or breast-feeding or trying to become pregnant
* Participating in another clinical (medical or nutritional) study or likely to be enrolled in another medical or nutritional protocol during this study