cyrilzakka/clinical-trials huggingface dataset:
Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

The purpose of our study is to determine if there is an antagonism between drugs used in the prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen after thyroidectomy.

It was shown that there was an antagonism of the ondansetron on the analgesia led by acetaminophen in a model of nociception by electrical stimulation using the PainMatcher in healthy volunteers. Our study try to determinate if a such antagonism exist in clinical conditions : 66 patients with an Apfel-score II undergoing thyroidectomy were randomized in 3 equal groups. Each group received an antiemetic (ondansetron, droperidol or dexamethasone) at the begining of the intervention and paracetamol at the end of the intervention for the postoperative analgesia. During 2 hours in the postoperative unit, we raised : the electrical pain's threshold with the PainMatcher, the numeric pain intensity scale and the presence of nausea or vomiting. For each patients we determined the cytochrome P450 2D6 activity that should have been able to explain a diminution of ondansetron's efficiency. Paracetamol blood levels were also raised in the postoperative unit.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thyroidectomy without lymph node dissection
* American Society of Anesthesiologists physical status from I to III
* Apfel-score equal to 2
* informed consent signed

Exclusion Criteria:

* pregnant and breast-feeding women
* addictive disorders
* psychic diseases
* allergy or contra-indication to a drug used in the study
* presence of postoperative nausea or vomiting
* administration of glucocorticoid for protecting recurrent laryngeal nerve.
* protocol not respected
* protocol refused by the patient
* intellectual handicap
Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data will be collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and older
* Resides in the United States
* Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue)
* Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid physical shipping address and mobile phone number
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Reports current enrollment in a clinical trial
* The QOL score greater than 5 during enrollment
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking any medication that warns against grapefruit consumption
* Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.

The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.


Eligibility Criteria:
Inclusion Criteria:1)Type 1 diabetes for at least 1 year

1. The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.

   2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion (CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative. Exclusion Criteria:1) Chronic oral steroid use

   2) The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of sensors or the completion of any aspect of the protocol.

   3) Known clinical history of celiac disease or inflammatory bowel disease. 4) Participants will have a negative anti-endomysial antibody or anti-tissue transglutaminase antibody within one year of enrollment.

   5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7) Currently pregnant or lactating, or anticipate getting pregnant in the next one year.

   8) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10 microunits per litter
Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.

Bladder cancer is the most common malignant neoplasm of the urinary system. Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard treatment for Muscle invasive bladder cancer.

Studer neobladder is one of the commonly used techniques for orthotopic reconstruction, originally utilizing 60-65 cm of the ileum. However, this leads to formation of a flaccid reservoir.

Nowadays, most techniques use 40-45 cm ileal segment only due to the proven increased reservoir capacity over time. So Moeen et al developed a modified Studer ileal neobladder by using a shorter ileal segment (40 cm only).

Upper urinary tract protection is important in neobladder reconstruction. One of the proposed anti-reflux techniques is using an isoperistaltic limp which was about 20 cm. This segment will be compressed by the elevated intra-abdominal pressure during Valsalva voiding to prevent reflux. However, this length was subjected to multiple reductions in multiple studies. Moeen et al used an 8 cm straight isoperistaltic ileal chimney.

In spiral neobladder the ureters are implanted into the reservoir using a non-refluxing split-cuff nipple technique. It has good functional and urodynamic parameters. Moeen et al added 8 cm as RT sided angled chimney over the neobladder. The ureters were implanted directly in an end to side manner. They assumed that adding this angulation to this short chimney decreases reflux and protect the UUT, without adding time to develop an anti-reflux technique.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with muscle invasive bladder cancer (T2-3N0-1M0).
2. Patients with T1 high grade bladder cancer with failed intravesical immunotherapy.
3. Bladder neck area including the trigone free from cancerous involvement.
4. Patients accepting the operation who are medically fit.

Exclusion Criteria:

1. Patients with serum creatinine ≥ 1.8 mg/dl.
2. Patients with intestinal disorders including previous bowel resections, severe diverticulosis or inflammatory bowel disease.
3. Inability to do perform clean intermittent catheterization (CIC) due to physical or mental impairment.
4. Sphincteric deficiency or urethral stricture disease causing voiding dysfunction.
5. Positive prostatic urethral biopsy.
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:

Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Eligibility Criteria:
Inclusion Criteria:

* All pediatric inpatient intensive care unit admissions
* Signed Informed Consent Form

Exclusion Criteria:

* Cyanotic congenital heart disease
* Not requiring mechanical ventilation
Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery

A randomized controlled trial study conducted by comparing the VAS score, swelling condition, knee ROM and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Having anterior cruciate ligament reconstruction
* Agree to be enrolled in study

Exclusion Criteria:

* Complex knee injury
* Raynard's disease
* Sensitive to low temperature
* Do not want to use cryotherapy
* Have vascular disease
Combination Chemotherapy in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining topotecan, fluorouracil, and leucovorin in treating patients who have advanced cancer.

OBJECTIVES: I. Evaluate the maximum tolerated dose (MTD) of continuous infusion topotecan in combination with fluorouracil for patients with advanced malignancy and establish a recommended phase II dose based on the MTD. II. Evaluate the dose limiting toxicity of this combination in these patients. II. Obtain pharmacokinetic and pharmacodynamic data for topoisomerase-1 depletion in patients receiving this treatment. IV. Identify any objective tumor responses arising from this treatment in these patients.

OUTLINE: This is a dose-escalation study of topotecan in combination with fluorouracil. Patients receive topotecan as a 24-hour continuous infusion on days 1-14 in combination with fluorouracil IV and leucovorin calcium IV on days 1-5; course repeats every 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients treated, subsequent cohorts each receive escalating doses on the same schedule. If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.

PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to hepatic metastases) LDH less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Alkaline phosphatase less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection requiring systemic therapy within 1 week prior to entry No significant concurrent illness No history of bleeding disorder or clotting factor deficiency No dementia or altered mental status that would prohibit informed consent Not pregnant or nursing Effective contraception strongly advised for fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during topotecan infusion Chemotherapy: At least 3 weeks since prior chemotherapy No more than 3 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy

study hypothesis

1. The aim of this study:

   How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
2. Study hypothesis

   * Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
   * Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy

Background and study purpose:

Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.

Eligibility Criteria:
Inclusion Criteria:

* Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
* No previous craniofacial surgery
* Patients agreed to attend this study and willing to sign the agreement
* Patients who are elder than 18 years old and after growth completion

Exclusion Criteria:

* Craniofacial anomalies
* cleft lip and /or palate patients
* patients without all the documents
* patients do not receive combined correcting nasolabial shape and orthognathic surgery.
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population. In order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in China, evaluate its safety and clinical benefit in a large Chinese population.

Cinepazide was firstly approved in France in 1974, and the formulations are injection and tablet. Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain, Italy. In some Aisa countries, it has not been re-registered in Japan in 2000s, and the injection is still used in China and Korea. In china, Cinepazide Maleate Injection was approved by China Food and Drug Administration(CFDA) in 2002, and widely used in cerebrovascular disease. The safety of the Cinepazide, especially the adverse drug reactions in the blood system, has not benn fully evaluated in Chinese population. In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection. This real world study for Cinepazide Maleate Injection with 18000 patients will be conducted from Sep. 2012 to June. 2014.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

* none
Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin

The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device.

Fifty-two final year students of Kocaeli University Medical School will participate to the study. The participants will complete the one-hour training lecture on the use of the Macintosh laryngoscope (ML) and the endotracheal tube introducer (ETI) that will be instructed by an emergency medicine specialist. The information section will be followed by a chance of practice each endotracheal intubation method once by using the ML with and without the ETI on the manikin.

Mechanical compression device will be used to perform chest compressions. The manikin will be placed on an ambulance stretcher in a supine position. Airway interventions will be performed in a sitting position on a seat that will be adjusted to the same height with the ambulance seat. The airway kit will be placed beside the head of the manikin.

Each participant will perform 2 airway interventions. Participants will be allowed for maximum 2 attempts for each method. Each procedure will be recorded to the video camera. The participants will be aware of the video camera. Following the interventions each participant will be asked to grade the difficulty of the both methods on a 5-point Likert scale defined as 1: very easy, 2: easy, 3: moderate, 4: difficult and 5: very difficult. The participants will be asked for whether they have prior clinical experience or not with ML or/and ML with ETI use.

Eligibility Criteria:
Inclusion Criteria:

* Participants who want to participate the study

Exclusion Criteria:

* Participants who do not want to participate the study
Does Block Play Improve Language Acquisition: A Randomized Trial

This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves.

Children in age group are randomized to get two sets of blocks or not. Outcomes include language development assessed using the Macarthur Bates CDI 6 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* healthy children

Exclusion Criteria:

* developmental delay, non-English
Sunitinib and Capecitabine for First Line Colon Cancer

This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer.

All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.

This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry.

In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria.

We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, newly diagnosed metastatic colorectal cancer
* Measurable or evaluable disease in which surgical resection with curative intent is not possible
* No adjuvant chemotherapy within 6 months of enrollment
* No prior sunitinib or other receptor tyrosine kinase inhibitors
* 18 years of age or greater
* Anticipated survival of at least 6 months
* Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight
* Normal organ and marrow function
* Must agree to avoid pregnancy or fathering a child through out study participation
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Chemotherapy or radiotherapy within 6 months of enrollment
* Receiving any other investigational agents
* Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
* Not able to ingest oral medications with normal absorption from the GI tract
* Uncontrolled hypertension
* History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment
* Cardiac dysrhythmias
* History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment
* Current treatment with therapeutic doses of coumadin
* Concurrent malignancy other than colorectal cancer
* Known dihydropyrimidine dehydrogenase deficiency
* Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements.
* Pregnant and nursing women
Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan

To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular carcinoma in Taiwan.

To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular carcinoma in Taiwan.

This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC bead TACE in hepatocellular carcinoma (HCC) in Taiwan

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7.

All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY, USA). Demographic and baseline lab data are presented by using descriptive statistics Student's t-test. Survival analysis will includes all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.
* Patient received DC bead TACE.

Exclusion Criteria:

* Patients with current any other cancer except non-melanomatous skin cancer.
* Infiltrative HCC
* Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no matter it is cTACE or DC bead TACE)
* Patients received DC bead TACE and simultaneously received other therapy, such as radiotherapy, sorafenib etc.
* Presence of collateral vessel pathways potentially endangering normal territories during embolization.
* Presence of arteries supplying the lesion not large enough to accept DC Bead® microspheres.