cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.

The cricothyroid membrane (CTM) is situated in the anterior neck and may be readily palpated in most people. In the event of difficulties securing the airway during a general anesthetic the CTM can facilitate emergency access to the upper airway to allow rescue oxygenation and ventilation. Caesarean sections are today carried out using either a spinal or epidural anaesthesia and for good reason. Due to physiological effects of pregnancy a patient's airway is known to be more challenging when pregnant than outside of pregnancy. The pregnant airway can even change over the course of labor. Airway ultrasound has become increasingly popular and allows accurate identification of airway structures including the cricothyroid membrane. It has already shown to be more accurate than palpation alone in identifying the cricothyroid membrane in obese pregnant women. The incidence of obesity in pregnancy continues to increase. Although regional anesthesia is preferred when these women require Caesarean section this is not always possible or successful. Use of a device to optimise patient position for airway management is the standard of practice for obese pregnant patients. These devices are known as head elevating laryngoscopy position pillows, the TROOP elevation pillow ® is one such device. However, the investigators do not know if and how positioning the obese pregnant patient on a TROOP elevation pillow ® affects position, depth and height of the cricothyroid membrane. The investigators want to know if the TROOP elevation pillow ® will hinder or facilitate the performance of a surgical airway in the event of failed airway management in the pregnant obese patient.

The investigators hypothesize that in pregnant obese patients in the third trimester use of the TROOP elevation pillow ® will change the position, height and depth of the CTM compared to the neutral position. Based on previous evidence the investigators believe the position of the membrane will move superiorly in relation to the sternal notch, will increase in height and the depth from the skin to the membrane will be reduced. The investigators also hypothesize that CTM identification and marking prior to final patient positioning may be misleading.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients in third trimester (\>28/40 weeks)
* Morbid Obesity (BMI≥40kg/m2)
* Ability to understand the rationale of the study assessments and to provide signed consent - Ability to safely and comfortably take part in the study protocol

Exclusion Criteria:

* Non pregnant patients
* Pregnant patients less than 28 weeks pregnant
* Not Morbidly Obese (BMI≥40kg/m2)
* Cervical spine pathology causing restricted neck movement or neurological compromise - Previous neck surgery or irradiation
* Upper limb neurology
* Patient refusal
Use of Nexstim SNBT System

The clinical investigation assesses the usability of the new graphical user interface of the Nexstim SNBT device in its intended clinical uses. The hardware and the technical functionality of the device of the SNBT device are in other respects similar to those of the earlier Nexstim NBT device, which has been cleared by FDA for treatment of Major Depressive Disorder in 2017 (K170902) and has received EU CE mark for the same and for treatment of chronic neuropathic pain.

The present investigation is not intended to establish the safety and efficacy of the SNBT device. Rather, the purpose is to assess the usability of the new user interface in a feasibility study conducted with a prototype device utilizing the new user interface.


Eligibility Criteria:
Inclusion Criteria:

* age 18-64 years signed informed consent form

Exclusion Criteria:

* pregnant implanted electrical device ferromagnetic metal anywhere in the body metal in head except amalgam dental fillings epilepsy migraine previous head trauma or surgery a diagnosed neurological disorder medication affecting the central nervous system
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion Criteria:

* Patients lipid level is outside the recommended range
* Patients that are HIV positive
Yulex Glove Prospective Study in Spina Bifida

This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein. Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy. In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period. The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data. Individuals with a history of anaphylaxis will be excluded from the study. The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study. The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with spina bifida between the ages of 18 and 60 who exhibit positive serology to latex (Hevea Brasiliensis).

Exclusion Criteria:

* Possible exclusion criteria include age under 18, does not have spina bifida, or does not exhibit positive serology to latex (Hevea Brasiliensis).
A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery

Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.

Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
* Subjects with up to 3.00 diopters of astigmatism.

Exclusion Criteria:

* Subjects under the age of 22.
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectatic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
* Subjects with 3.25 or more diopters of astigmatism
* Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers

Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.

In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated.

After all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 18-75
* Use of appropriate form of birth control for women of childbearing potential.

Exclusion Criteria:

* H pylori infection
* Use of NSAIDs within 2 weeks prior to start of enrollment
* Use of antacids or H-2 blockers within 2 weeks of enrollment
* Use of PPIs within 30 days of enrollment
* Corticosteroid use within 60 days of enrollment
* History of a previous ulcer
* Diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment
* Use of cigarettes within 6 months of enrollment
* Consumption of \>3 alcoholic beverages per day
* Hypersensitivity or allergy to NSAIDs, clopidogrel, or corn starch, or any contraindications to ingesting those substances
* The presence of an ulcer at a baseline endoscopy
* Endoscopically severe gastritis or duodenitis baseline endoscopy
* Moderate or severe inflammation located within the duodenal bulb or within 2cm of the pyloric channel at a baseline endoscopy
* Any gastroduodenal tumor.
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders

PMCF study to further substantiate the effectiveness and safety of OSTENIL® TENDON in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 18 and 99 years
* Diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band)
* Physician's recommendation to use OSTENIL® TENDON prior to recruitment
* Signed informed consent

Exclusion Criteria:

* Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e.,

  * Ascertained hypersensitivity to any of the OSTENIL® TENDON constituents
  * Known pregnancy or breast feeding
  * Acute trauma
* Use of the following treatments (the given time intervals refer to the date of inclusion):

  * Local\* OSTENIL® TENDON or other hyaluronic acid (HA) treatment within the last 6 months
  * Local\* platelet-rich plasma (PRP) treatment within the last 3 months
  * Local\* corticosteroid treatment (without time restriction)
  * Local\* extracorporeal shock wave therapy (ESWT) within the last 4 weeks
  * Local\* phytotherapy (e.g., Traumeel®) within the last 4 weeks
  * Local\* surgical intervention (without time restriction)
  * Systemic corticosteroid treatment within the last 4 weeks
  * Repeated use of non-steroidal anti-inflammatory drugs (NSAID) and/or other analgesics within the last week
  * Physiotherapy (therapeutic exercises and physical therapy), ortheses, transcutaneous electrical nerve stimulation (TENS) or acupuncture within the last week
* Diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, Bechterew disease, Crohn's disease, etc.) prior to inclusion
* Participation in a clinical investigation within the last 6 months
* Vulnerable patient (individual who is unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response \[including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language\])

(\* local refers to the treatment of the study-relevant tendon)
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy

The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* The patient has kidney stones that require treatment (tx) with percutaneous stone removal
* 18 years of age or over

Exclusion Criteria:

* Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
* Patient taking coumadin
* Pre-existing percutaneous nephrostomy
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.

II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.

RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented uterine carcinosarcoma with no visible residual disease
* Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
* Patients must be entered no more than 12 weeks post operatively
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Written voluntary informed consent

Exclusion Criteria:

* Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal
* Total serum bilirubin \> 1.5 mg/dl
* History of chronic or active hepatitis
* Serum creatinine \> 2.0 mg/dl
* Platelets \< 100,000/mm3
* Absolute neutrophil count (ANC) \< 1500/mm3
* Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
* Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
* Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
* Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
* Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with LDAC \[Low-Dose Ara-C\] or cytarabine and daunorubicin in previously untreated patients with AML \[Acute Myeloid Leukemia\] or high-risk MDS \[Myelodysplastic Syndrome\], or in combination with azacitidine in previously untreated patients with AML.


Eligibility Criteria:
Inclusion Criteria:

* Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort.
* Patients with AML or High-Risk MDS who are newly diagnosed and previously untreated for combination cohort.
* Patients with AML who are newly diagnosed and previously untreated for azacitidine combination cohort.
* ECOG \[Eastern Cooperative Oncology Group\] performance status 0 to 2
* Adequate organ function

Exclusion Criteria:

* Patients with active CNS disease
* Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical
* Patient has an active, life threatening or clinically significant uncontrolled systemic infection
Development of a Biomarker for Dietary Furanocoumarins

Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. This study will develop a urine test to determine if an individual ate foods that contain furanocoumarins.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Healthy

Exclusion Criteria:

* History of gastrointestinal, hepatic or renal disorder
* Currently taking any prescription or over-the-counter medication
* Currently taking any herbal supplement
* Pregnant or lactating
* Allergies to foods that will be used (parsnips and parsley)
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.

Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. The primary aims of this study were to define the relationship between cricoid and mainstem bronchi (right and left) in children of various ages and to determine the effects of age, height and weight.

Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.

Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.

Eligibility Criteria:
Inclusion Criteria:

* Children 1 month to 8 years of age

Exclusion Criteria:

* Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants
Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery

The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P \< 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P \< 0.001) and between -20 min and 10 min (P \< 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P \< 0.001), which returned to the baseline after 20 min.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were: being aged between 16 and 70 years;
* with a body mass index of 18-25 kg/m2;
* with a physical status classified as ASA class I or II;
* and scheduled for elective craniotomy

Exclusion Criteria:

* Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;
* had a previous history of intra-aortic balloon counterpulsation;
* exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;
* or rejected to participate in this study.