cyrilzakka/clinical-trials huggingface dataset:
Cryoablation for Obesity Management

The purpose of this study is to assess the efficacy of cryoablation therapy for the treatment of mild to moderate obesity and test the safety (good and bad effects) of this procedure. The vagus nerve transmits hunger signals from the stomach to the brain, and in response transmits stomach expansion signals from the brain to the stomach. Investigators believe that by interrupting this communication, participants could experience less hunger and in turn lose weight.

The purpose of this single arm study is to assess the efficacy of cryoablation therapy for the treatment of mild to moderate obesity and test the safety (good and bad effects) of this procedure. The vagus nerve transmits hunger signals from the stomach to the brain, and in response transmits stomach expansion signals from the brain to the stomach.Investigators believe that by interrupting this communication, participants could experience less hunger and in turn lose weight.

The rationale for using cryoablation to treat obesity is based on this investigator's experience safely targeting peripheral nerves via CT guidance and treated with thermal ablation in daily clinical practice. the primary objective of this research is to evaluate the feasibility and safety (over time) of percutaneous image guided cryoablation of the posterior vagus nerve in obese patients. The secondary objective consist of temporal evaluation of weight loss and appetite before and after the procedure. This will be analyzed through documentation of weight, and through the implementation of validated outcome instruments.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 30-35
* Weight loss refractory to diet changes or exercise
* Absence of coagulopathy
* Ability and willingness of patient to provide written informed consent

Exclusion Criteria:

* Active infection
* Underlying congenital anatomic or other spinal anomalies that result in non-conventional anatomy at the gastro-esophageal junction
* Pregnant or planning to become pregnant
* Immunosuppression
* History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of cryoablation
* Uncorrectable coagulopathies
* Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days
* Have undergone a previous bariatric surgical intervention
The Effect of Music Therapy on Nurses

This study was planned to examine the effect of music therapy on the comfort levels of nurses. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again.

This study was planned to examine the effect of music therapy on the comfort levels of nurses. This study will be conducted as a randomized controlled experimental study. In the sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the control group. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again. Research data will be analyzed in SPSS-25 package program.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one year of working experience
* Have not participated in any music therapy session before
* No hearing problems
* Absence of neurological/psychiatric disorders
* Nurses who volunteered to participate in the study will be included in the study.

Exclusion Criteria:

* Those who use another relaxation methods,
* Nurses who do not agree to participate in the study will not be included in the study.
Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.

These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be female and attend a participating clinic
* Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months)
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors)
* In addition, the subject must meet at least one of the following criteria:

  * Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
  * Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
  * Subject must be asymptomatic and undergoing screening evaluation for possible STDs
  * Subject must be undergoing Pap screening

Exclusion Criteria:

* Subject took antibiotic medications within the last 14 days
* Subject already participated in the study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes

There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients. The purpose of this study is to see how easily anesthesiologists can learn to use them in children.

Each anesthesiologist performed 20 timed baseline intubations. They were then randomized to perform 20 timed intubations with one of the two new videolaryngoscopes followed by 20 with the other new videolaryngoscope. The goal was to see how quickly they could become proficient.

Eligibility Criteria:
Inclusion Criteria for Children Population:

- Children requiring intubation for elective or non-elective surgery

Exclusion Criteria:

* Children with raised intracranial pressure
* Children with potential cervical spine injuries
* Children at risk for regurgitation because of a full stomach
* Children who were anticipated to have a difficult airway based on their physical appearance or previous experience were excluded.

Inclusion Criteria for Anesthesiologist Population:

\*Anesthesiologists who care for children at Stollery Children's Hospital

Exclusion Criteria for Anesthesiologist Population:

\*None
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.

This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.

Eligibility Criteria:
Inclusion Criteria:

* age 10-18 years old
* pediatric patients who will undergo the surgical correction of idiopathic scoliosis

Exclusion Criteria:

* a history of chronic pain (use of gabapentin/pregabalin for \> 3 months or opioid use \> 1 repeated opioid prescription in the last three months)
* morbid obesity (BMI \> 99th percentile)
* previous surgery
* back abnormalities
* infection at block application area
* coagulopathy
Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults

. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome

Currently, over 47 million adults in the United States are known to have metabolic syndrome. Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have an increased risk for the development of chronic diseases such as cardiovascular disease and diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and obese people may partially explain the link between metabolic syndrome and the development of chronic diseases. There is evidence to suggest that diets with a higher amount of protein can improve some aspects of metabolic syndrome, including the build-up of fat in muscle. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

BMI: 25-38 ,male or female; age 35-65 y; weight stable (± 3 kg) during last 3 months; no acute illness; not diabetic, pregnant or lactating; not currently (or within last 3 months) following an exercise or weight loss program; non-smoking; not taking BP medication; not lactose intolerant,

Exclusion Criteria:

Subjects will be excluded if baseline protein intake is less than 0.6 or greater than 1.6 g•kg-1•d-1 Subjects will also be excluded if they have any chronic or acute condition which will increase risk of illness or injury during study participation as determined by our study physician such as high BP, high fasting glucose, metabolic syndrome, etc.
Ketonemia Through Menstrual Cycle

Ketogenic dietary therapies (KDTs) are well-established, safe, non-pharmacologic treatments used for children and adults with drug-resistant epilepsy and other neurological disorders. Ketone bodies levels undergo a significant inter-individual and intra-individual variability and can be affected by several factors. This evidence suggests the need for personalized monitoring for diet optimization, especially at the beginning of the treatment but during whole follow-up. Possible variations in glycemia and ketone bodies' blood level according to different phases of menstrual cycle have not been systematically assessed yet, but this time window deserves special attention because of hormonal and metabolic related changes. We present the methodological protocol for a longitudinal, multicentric study aimed at searching for subtle changes in ketone bodies blood level during menstrual cycle in epileptic female patients undergoing a stable ketogenic diet. The study will be divided into two phases. The first one will be purely observational, aiming at the assessment of ketonemia during menstrual cycle. Whether this finding will be confirmed, a second phase of ketogenic diet therapy adjustment will be scheduled.


Eligibility Criteria:
Inclusion Criteria:

* Patients with drug resistant epilepsy or GLUT1DS undergoing KD from at least 3 months before inclusion to the study
* Patients who had menarche at least 3 months before inclusion to the study
* Absence of recognized endocrinologic problems/ disease

Exclusion Criteria:

* Patients who experienced secondary amenorrhea
* Patients who have irregular menstrual cycle
* Pregnant patients
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.

External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.


Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
* Negative pregnancy test (for women who are able to become pregnant)

Exclusion Criteria:

* Women who are pregnant, lactating or planning to become pregnant during the study
* Evidence of clinically significant or unstable disease (such as stroke, heart attack)
* Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
* Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.
Life Quality and Health in Patients With Klinefelter Syndrome

Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1 in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter syndrome have psychological complaints and physical discomfort. Some patients report a positive effect of testosterone treatment, whereas others do not.

The aim of this study is:

(i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate functional, physical and mental health in patients with Klinefelter syndrome.

Questionnaire concerning mental and physical health and life quality are sent out to patients with KS and to age-, educational- and zipcode-matched men from the general population. The questionnaire include questions about housing, income, marital status, fatherhood, medication, chronic disease,school and education, attachment to the labor, sexual and erectile function, life quality, mental and physical health, satisfaction with life and symptoms of attention deficits hyperactivity disorders.


Eligibility Criteria:
For the Klinefelter group:

Inclusion Criteria:

* Verified Klinefelter syndrome

Exclusion Criteria:

* none

For the control group:

Inclusion Criteria:

* age-,educational,and residence-matched

Exclusion Criteria:

* none
Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy

The FloTrac/Vigileo is a minimal invasive device assessing flow based hemodynamic parameters by pulse contour analysis based on the radial artery pressure signal. This method gained popularity as it is minimally invasive compared to esophageal Doppler or pulmonary artery catheter insertion and provides continuous beat-to-beat data. The previous study with 110 patients found that that GDHT guided by stroke volume variation (SVV) using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of POGD in major abdominal oncological surgery. However, no difference was found in the incidence of postoperative complications between the two groups, lack of statistical power could be a limitation to demonstrate the true association. Therefore, further prospective trials are needed to address this issue.

The use of early and efficient therapeutic strategies able to detect and to treat potential triggers of organ failures, such as tissue hypoperfusion, is particularly important. If hypoperfusion is not adequately managed, tissue hypoxia could occur, resulting from an impairment of the adaptive mechanisms of myocardial contractile function, under the influence of inflammatory mediators, and the peripheral tissues will then increase their oxygen extraction (O2ER). AS such, GDHT guided by O2ER may be appropriate to monitor GDHT strategies because it reflects the balance between oxygen delivery and consumption.

Therefore, the investigators performed this single-center, randomized, controlled trial to investigate whether GDHT guided by SVV using FloTrac/Vigileo monitor and GDHT guided by O2ER would reduce incidence of postoperative complication and shorten the length of hospital stay, compared with a standard conventional fluid therapy in low-to-moderate risk patients undergoing major laparoscopic gastrointestinal oncological surgery.


Eligibility Criteria:
Inclusion Criteria:

1. 18\~80 years
2. ASA I\~III
3. Patients undergoing elective major laparoscopic gastrointestinal oncological surgery.Procedures were considered major if listed for resection cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss.

Exclusion Criteria:

1. co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine \>50 % or liver enzymes \>50 % of normal values), and arrhythmias.
2. less than 18 years
3. pregnant or lactating woman
4. patients undergoing emergency surgery
Breast Cup Immobilization Device II (GCC 1047)

The study is designed to assess the accuracy of patient breast reproducibly using the revised BCID. This study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a TBB or accelerated partial breast irradiation. The BCID is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites.

Breast conserving therapy (BCT) has become the standard of care for treating early-stage breast cancers based on six prospective randomized trials with 20 years of follow-up data (Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), leaving surgical clips to help designate the resection bed. Radiation treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2 week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures \[Romestaig; Bartelink\].

Studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy. In the group of patients who received surgery alone, 85% of the breast recurrences occurred in the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must consent to be in the study and have signed an IRB-approved consent form.
2. The patient must have a diagnosis of invasive or non-invasive breast cancer.
3. The patient must be planned for or have already had breast conservation surgery (i.e. lumpectomy).

4 Age \> 18. 5. There are at least two metal clips in the surgical cavity placed at the time of surgery for guiding the radiation oncologist in delineating the target of irradiation; or one radiographic clip placed at the time of stereotactic core needle biopsy with the intact tumor.

6. Patients who have already been treated by radiation therapy and are being seen in follow-up can also participate

Exclusion Criteria:

1. Male gender
2. Patients who cannot be set up comfortably in the prone position (e.g. physical disability)
3. Tumor/lumpectomy site located in a portion of the breast that cannot be visualized easily on the CT scan (e.g. superior portion of the upper outer quadrant).
4. Mastectomy was or is the recommended surgical approach.
Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D

The primary goal is to correlate beta cell mass to beta cell function from measurements during and shortly after the honeymoon phase of type 1 diabetes, to improve understanding of the change in metabolic control after the honeymoon phase.

The exact role of beta cell mass during the development and course of diabetes is still poorly understood. Further research on beta cell mass is essential to obtain more insights that might aid in the development of diabetes treatment. This study aims at a specific phase of T1D that is called the 'honeymoon phase' or period of partial remission. Once insulin treatment has started, the honeymoon phase will arise in most patients. In this period, T1D patients become temporarily less insulin-dependent. Unfortunately, the honeymoon phase is only temporary, in which a decline in blood glucose regulation will be seen afterwards, leading to an increasing demand for insulin. To increase understanding of this change in metabolic control after the honeymoon phase, repeated measurements of the beta cell mass and function are performed during and shortly after the honeymoon phase. The comparison of both measurements might lead to an increased understanding whether changes in insulin demand after the honeymoon phase is mainly dependent on a decline in the beta cell mass, or because of a decrease in functional beta cells. The outcome of this study can provide new insights, which can contribute to the development of novel treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years
* Diagnosed with T1D
* Presence of anti-GAD
* Subject is in honeymoon phase
* 17 ≤ BMI ≥ 30 kg/m\^2 at moment of visit
* Ability to sign informed consent

Exclusion Criteria:

* Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
* Liver disease
* Renal disease
* Pregnancy or the wish to become pregnant within 6 months after the study
* Breastfeeding
* BMI \<17 kg/m2 or BMI \>30 kg/m2
* Age \<16 years
* When the end of the honeymoon phase is not observed within 11 to 13 months after the inclusion of the subject
* Inability to sign informed consent