cyrilzakka/clinical-trials huggingface dataset:
Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.

This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
* Age above 18 years;
* Physical State American Society of Anesthesiologists (ASA) II and III;
* Weight between 50kg and 120kg;
* Height between 140cm and 180cm.

Exclusion Criteria:

* Refusal to participate in the study;
* Pregnant women with fetus with known abnormalities;
* Pregnant women with cardiovascular disease;
* Pregnant women with pregnancy-specific hypertensive disease;
* Allergy to any medication to be used in the study;
* Users of monoamine oxidase inhibitors;
* Users of tricyclic antidepressants;
* Emergency caesarean section due to acute fetal distress;
* Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia.
Effect of Food Form on Satiety and Gastric Emptying

Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch.

Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 18 - 35
* Body mass index in the healthy range between 18.5 and 25
* Proficient English speakers
* Non-smoking
* Not taking medications
* Non-dieting (weight stable over last 3 months)
* Able to swallow a large capsule

Exclusion Criteria:

* Irregular or erratic breakfast eating patterns
* Food allergies to ingredients commonly found in test products or pizza
* Distaste for test products or pizza
* BMI less than 18.5 or greater than 25
* Weight change \> 5 kg in last 3 months (intentional or unintentional)
* Difficulty swallowing
* Cardiovascular disease
* Diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* Cancer in prior 5 years (except basal cell carcinoma of skin)
* Kidney or liver disease
* Any gastrointestinal conditions that may affect digestion and absorption
* Recent bacterial infection (\< 3 months)
* Chronic medication use
* History of drug or alcohol abuse in prior 6 months
* Concurrent or recent intervention study participation
* Vegetarians or people who ate more than approximately 15 g of fiber per day
* Pregnant or lactating women
* Women with irregular menstrual cycles
Prevalence and Predictive Factors of Difficult Biliary Cannulation

The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study

We will also assess:

Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria.

Design an "a priori" predictive model for difficult cannulation and cannulation failure.

Cost study: record of materials used.

All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.

The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.

After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.

Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients. For each variable included in the multiple logistic regression analysis, 8 to 10 cases of patients with difficult cannulation would be required.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Signed informed consent
* Patients indicated for ERCP

Exclusion Criteria:

* INR \> 1.5
* Platelets \< 50,000/mm³
* Patients with a prior endoscopic sphincterotomy
* Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
* Known pancreas divisum
* Indication due to pancreatic duct pathology
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS

The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Eligibility Criteria:
Inclusion Criteria:

* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
* Signed a valid, IRB/EC/REB-approved informed consent form

Exclusion Criteria:

* Meets any contraindications per locally applicable Directions for Use (DFU)
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years of age or older.
* Signed informed consent form, which meets all criteria of current FDA regulations.
* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.

Exclusion Criteria:

* Females who are pregnant, lactating or likely to become pregnant during the study.
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.
* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
* Patients who would be non-compliant with the requirements of the study protocol.
* Participation in a research study within 30 days prior to baseline visit.
* Employees or family members of employees of the research center or investigator.
* Previous participation in this study.
SuperNO2VA™ and General Anesthesia Postoperative Care

The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively in PACU)


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age or older
2. Patients scheduled for general anesthesia with a supraglottic device or ETT
3. American Society of Anesthesiology (ASA) Physical Status I-IV (E)
4. Has provided written informed consent
5. BMI \> 35 kg/m2 or documented Obstructive Sleep Apnea

Exclusion Criteria:

1. Inability to give informed consent
2. ASA V (E)
3. Allergy to Propofol
4. Any condition, in the Investigator's opinion, that would conflict or otherwise prevent the subject from complying with study required procedures, schedule or other study conduct
5. BMI \< 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea
6. Known diagnosis of moderate to severe COPD/lung disease
7. Patients that remained intubated post-operatively
8. Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively
Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant melanoma
* Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
* Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

* Active/symptomatic brain metastases
* Primary ocular melanoma or primary tumor of unknown origin
* Concurrent autoimmune disease
* Previous treatment with a CD137 agonist or CTLA-4 inhibitor
Evaluation of the Safety and Efficacy of Hemophilia B Gene Therapy Drug

This is a multi-center, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels.

BBM-H901 is an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene and raises circulating levels of endogenous FIX.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age;
2. Have hemophilia B with ≤2 IU/dL (≤2 %) endogenous FIX activity levels;
3. Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products based on historical data from the subjects' records/histories;
4. Have had bleeding events and/or injected with FIX protein products (including recombination and plasma source) during the last 12 weeks documented in the subjects' medical records;
5. Have no prior history of hypersensitivity or anaphylaxis associated with any FIX or IV immunoglobulin administration;
6. Agree to use a reliable barrier contraception method from the beginning of signing the informed consent to 52 weeks after administration.

Exclusion Criteria:

1. Being positive for hepatitis B surface antigen (HBsAg) or hepatitis B virus-DNA (HBV-DNA). Being positive for hepatitis C virus antibody (HCV-Ab) or hepatitis C virus RNA (HCV-RNA). Subjects with medical history of hepatitis B or C can be regarded as negative only when 2 required samplings are conducted at least 3 months apart and both test results of indicators aforementioned are negative, i.e. subjects with natural clearance and anti-viral therapy clearance for hepatitis B or C are eligible;
2. Have potential liver diseases, such as previous diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy or liver fibrosis (fibrosis stage ≥ 3); nodules or cysts were found by B ultrasound, or elevated alpha-fetoprotein was detected by laboratory tests. Subjects who are not eligible for the study if the abnormalities are clinically significant regarding to the medical judgement of the investigator;
3. HIV positive patients;
4. Have participated in a previous gene therapy research trial before screening, or in a clinical study with an investigational drug within 5 half-life of the investigational product, whichever is longer;
5. Have alcohol or drug dependence, or cannot stop drinking throughout the study;
6. Any concurrent clinically significant major disease or condition that the investigator deems unsuitable for participation in the study.
Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin

The purpose of the study is to compare the changes in the appearance of dry skin after the use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil in patients with dry skin.

The goal of this study is to compare how the appearance of dry skin changes before and after the use of following moisturizers: white petrolatum, coconut oil, jojoba oil and almond oil). Up to 40 subjects from Banner-University Medical Center/University of Arizona dermatology clinics and University of California, Davis dermatology clinics (up to 20 subjects per site) who have dry skin will be enrolled in this study and randomized to receive the four moisturizers on four locations on their forearms.There will be a total of 3 study sessions: baseline, and approximately 1 and 2 weeks for follow up assessment. At each visit, dry skin severity will be evaluated by a trained observer using a validated Dry Skin Score, skin barrier biophysical properties (transepidermal water loss and hydration) will be measured, and digital photos of the test sites will be taken for image analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female, at least 18 years of age
2. Subject must receive a diagnosis of dry skin by a dermatologist.
3. Subject must be able to comprehend and read the English language.

Exclusion Criteria:

1. Subjects who do not fit the inclusion criteria.
2. Subjects unable to or unwilling to comply with the study procedures
3. Prior known allergy to white petrolatum, coconut oil, almond oil, or jojoba oil.
4. People who have used products containing white petrolatum, jojoba oil, coconut oil, or almond oil within the past week.
5. People with a known diagnosis of ichthyosis.
6. A subject who, in the opinion of the investigator, will be un-cooperative or unable to comply with study procedures.
7. Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
8. Those that are prisoners or cognitively impaired
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway

Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.

The study aims to compare the two devices with respect to:

Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Physical Status I \& II
2. Patients undergoing limb or breast surgery
3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
4. Patients with expected duration of surgery of less than 2 hours.

Exclusion Criteria:

1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
2. Patients with mouth opening of less than 2.5 cm or cervical spine disease
3. Patients with H/o upper respiratory tract infection in the previous 10 days.
4. Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
5. Patients with a body mass index (BMI) \> 30 kg/m2
6. Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.

8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery

In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.

After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to 3 inclusively
* breast cancer surgery with or without axillary dissection

Exclusion Criteria:

* any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
* refusal to participate in the study
* patient with dementia
* preoperative breast pain
* preoperative opioid consumption
* breast reconstructive surgery
* bilateral surgery
* pregnant patient