cyrilzakka/clinical-trials huggingface dataset:
The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* patients for surgery not exceed more than 2 hours requiring general anesthesia

Exclusion Criteria:

* history of gastroesophageal reflux High grade obesity Predicted diffiicult airway
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease (CKD) patients with iPTH \>=300 pg/mL, adjusted calcium \>=8.4 to \<10.2 mg/dL, and phosphorus \<=6.5 mg/dL
* Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
* Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained

Exclusion Criteria:

* Patients taking drugs that affect iPTH, calcium, or bone metabolism
* Patients with a history of allergic reaction or significant sensitivity to vitamin D
* Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
* Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease
* Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:

  * Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
  * Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
  * Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
  * Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)
* Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic \>= 180 mmHg and diastolic \>= 110 mmHg)
* Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin \>=8% for 3 months before informed consent was obtained)
* Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
* Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
* Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
* Patients who have taken paricalcitol in the past
Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer.

OBJECTIVES: I. Determine the objective response rate to irinotecan in patients with metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy for metastatic disease. II. Determine the toxicities of irinotecan in these patients. III. Determine survival time, duration of response, and time to treatment failure in these patients after this therapy.

OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, then every 3 months.

PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced breast cancer Must have received anthracycline and taxane based chemotherapy for metastatic disease Measurable disease No CNS metastases or carcinomatous meningitis Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1500/mm3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.3 mg/dL SGOT no greater than 3 times upper limit of normal (no greater than 5 times ULN if liver involvement) No Gilbert's disease Renal: Creatinine no greater than 2.0 mg/dL Calcium at least 12.0 mg/dL Cardiovascular: No myocardial infarction in the past 6 months No congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would preclude study No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No uncontrolled diabetes mellitus (random blood sugar at least 200 mg) No other severe disease that would preclude study Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Greater than 4 weeks since prior chemotherapy No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy No radiotherapy to greater than 30% of bone marrow Surgery: Not specified Other: No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis
Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia

In breast reduction surgery, pain control is usually performed with tumescent anesthesia, thoracic epidural anesthesia, intercostal nerve blocks and paravertebral block applications. Tumescent anesthesia is also preferred by plastic surgeons because of the varying risk of thoracic epidural anesthesia and paravertebral block applications.

After the Erector spinae block was first described by Forero in 2016, it was reported to have been applied in many cases, including breast surgery.

It is considered to be a safer block because of the presence of paravertebral block-like activity and the location where the needle is guided away from the pleura. The investigators aimed to compare postoperative analgesia consumption, pain scores and patient satisfaction of erector spine block with tumescent anesthesia in patients who underwent reduction mammoplasty operation under general anesthesia in this double-blind prospective randomized study.

Patients aged 18-65 years undergoing bilateral reduction mammoplasty. Patients were randomly divided into two groups with closed envelope to perform tumescent anesthesia and erector spinae block.

All patients were premedicated with oral midazolam 0.5 mg/ kg preoperatively. All patients received standard general anesthesia protocol as induction with 2-3 mg/kg iv propofol and 1-1.5 mcg/kg fentanyl and 0.6 mg/kg iv rocuronium. Endotracheal intubations were performed 7.0 or 7.5 endotracheal tubes with the patient in a supine position. Anesthesia maintenance was with sevoflurane 0.5/kg/mg remifentanil infusion and in a 50% O2 -50% air mixture. Standard monitoring of the patients included of heart rate, invasive systolic, diastolic and mean blood pressure and peripheral oxygen saturation and the operating times were recorded.

At approximately 30 minutes before the end of surgery, 8mg dexketoprofen IV was administered to all patients. At the end of the operation, all the patients were performed with iv PCA(Patient Controlled Analgesia).

Demographic data such as age, weight, and height of the patients were recorded. After patients informed about pain score NRS (Numeric Pain Rating Scale) and patient satisfaction score ( one to ten) recorded by the nurse of PACU and ward.

Eligibility Criteria:
Inclusion Criteria:

The American Society of Anesthesiologists physical status classification I-III undergoing reduction mammoplasty

Exclusion Criteria:

History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding diatheses Coagulopathy liver diseases
ACTH Gel Therapy in Rheumatoid Arthritis

The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.

ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.

This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* 18 year of age and older
* RA diagnosis by American College of Rheumatology criteria
* Active disease (CDAI \> 10)
* Have received at least are biologic agent for at least 6 months
* May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
* No current active infections requiring antibiotics
* Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)

Exclusion Criteria:

* Less than 18 years of age
* Unable or unwilling to give Informed Consent
* Have an active infection requiring the use of antibiotics
* Women who are pregnant
* Uncontrolled hypertension
* Abnormal renal function
* Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Aminocamptothecin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Cancer of the Peritoneum

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum.

OBJECTIVES: I. Estimate the antitumor activity of aminocamptothecin colloidal dispersion in patients with platinum-resistant recurrent or refractory ovarian cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of aminocamptothecin colloidal dispersion in this patient population.

OUTLINE: Patients receive aminocamptothecin colloidal dispersion IV over 120 hours weekly for two of every three weeks. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 23-56 patients will be accrued for this study within 5-12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal carcinoma Progressive disease on platinum-based treatment alone or in combination Two prior treatment regimens allowed only if other regimen was paclitaxel OR recurrence within 6 months of chemotherapy Measurable disease Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 13 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection Not pregnant Fertile patients must use effective contraception At least 5 years since prior malignancy; no prior chemotherapy or radiotherapy for that malignancy No concurrent malignancy other than non-melanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior treatment with aminocamptothecin Endocrine therapy: At least 4 weeks since prior endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to site(s) of measurable disease used on this trial No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: At least 4 weeks since prior surgery
Providing Online Counseling for Home-Based HIV Testing With Transgender Youth

This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.


Eligibility Criteria:
Inclusion Criteria:

* male sex at birth, identifies as female, trans feminine, trans woman, female
* female sex at birth, identifies as male, trans male, trans masculine, male
* agender, genderfluid, genderqueer
* between the ages of 15-24,
* negative or unknown HIV status and not having tested in the least 3 months
* willingness to have HIV test kit delivered to an address they provide
* wilingness to be tested for HIV
* willingness to be randomized to either study arm
* willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, internet access)

Exclusion Criteria:

* same sex assigned at birth and currently identifies as that same sex
* aged 14 years or younger, or 25 years or older
* reports having a positive HIV status during the baseline survey or screener survey before testing unwillingness to have HIV test kit delivered to an address they provide
* unwillingness to test for HIV
* unwillingness to be randomized
* unwillingness or inability to participate in video-based counseling
Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis

The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants \<1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.

All infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines.

The investigators goal was to target the time period these infants are at high-risk for infection or NEC and its associated mortality. The targeted time was the first 4 weeks of life or longer while intravenous access is still required. The average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in patients still requiring IV access (peripheral or central). The presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). This strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<1000 grams or gestational age ≤28 weeks
* less than or equal to 7 days of age

Exclusion Criteria:

* greater than 7 days of age
Controlled Ventilation CT in CF Infants

The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.


Eligibility Criteria:
Inclusion Criteria:

1. Infants and young children (age \~ 2/3 months to \< 5 years)
2. Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
3. Informed consent by parent or legal guardian.
4. Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria:

1. Acute wheezing and/or respiratory distress at either study visit.
2. Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
3. Oxygen saturation \< 90% on room air at study visit.
4. Any medical condition that in the opinion of the investigator precludes subject participation.
Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

The purpose of the proposed study is to examine the relationship between marijuana reminders, or "cues", craving for marijuana, and marijuana use. The principal investigator is also assessing whether N-acetylcysteine, can reduce marijuana craving or use.

This study involves three screening sessions that could last about 3 hours each.

Part of this study will be conducted on an inpatient unit where the participant will live for 4 straight nights.

During the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank). Participants will be asked to take capsules that could contain N-acetylcysteine or placebo (blank).

Participants will be asked to complete questionnaires and have vital signs (blood pressure, heart rate) monitored.

Participants will be asked to participate in overnight sleep recordings, a polysomnogram (PSG).

Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy individuals 21-55 year olds who use marijuana.
* Marijuana use will be verified by self-report and THC-positive urine samples. -Participants must meet DSM 5 criteria for Cannabis Use Disorder and be willing to participate in research but not seeking treatment.

Exclusion Criteria:

* Candidates with the following conditions will be excluded:
* Serious psychiatric illness (e.g. psychotic or bipolar disorder
* Recent (past 5 years) suicide attempts
* Major depression that is not substance-induced)
* Substance Use Disorders (SUD) other than Cannabis or Nicotine Use Disorders and Mild Alcohol Use Disorder
* Neurological diseases (e.g. stroke, seizures)
* Cardiovascular problems (e.g. myocardial infarction, angina, systolic BP \>160 or \<95 mmHg, diastolic BP \>95 mmHg, clinically abnormal ECG)
* Pulmonary diseases (e.g. asthma, TB)
* Systemic diseases (e.g. hepatitis, autoimmune, Cushing syndrome)
* Cognitive impairment (\<80 IQ)
* Past-month exposure to medications that increase study risk (e.g. toxicity to major organs, asthma inhalers)
* Women who are pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral/depot contraceptives, IUD, condom/foam, sterilization, tubal ligation)
* Seeking treatment for a Substance Use Disorder.
* Individuals unable to give voluntary informed consent will be excluded. Applicants interested in treatment will be excluded from the study and referred to a treatment program.
SAGIT for Classification of Patients With Acromegaly in Clinical Practice

The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies.

In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years-old or above
* Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
* Controlled/stable, active and treatment naïve patients.
* Patient with the cognitive and linguistic capacities to understand the information letter of the study
* Patient who signed informed consent

Exclusion Criteria:

* History of non-compliance or inability to reliably receive treatment in the foreseeable future
* Gaps in treatment of greater than 1 month within the 12 months prior to study entry