cyrilzakka/clinical-trials huggingface dataset:
Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy

The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.

DEFINITY is a contrast agent that is used to create better quality ultrasound images.

On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.

During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.

You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Length of Study:

Your active participation in this study will be over after you have completed the follow-up visit.

Follow-Up Phone Call:

You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete.

This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology.

Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
2. Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
3. Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)

Exclusion Criteria:

1. Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
2. Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
3. Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
4. Pediatric patients less than 18 years of age.
5. Pregnant or nursing mothers.
China Post-marketing Surveillance (PMS) Study of Aldurazyme®

This is a single treatment arm study that is open-label to be conducted in Chinese participants with MPS I.

Trial Objectives are to evaluate the safety and tolerability of Aldurazyme in Chinese MPS I participants, and to evaluate the efficacy of Aldurazyme on the percent change of urinary glycosaminoglycans (uGAGs) from baseline to Week 26. The study will also evaluate the effect on uGAG level and liver volume (hepatomegaly) after 26 weeks, with Aldurazyme treatment in Chinese MPS I participants.

Treatment duration will include: 2 weeks of screening, 26 weeks of treatment and 1 week of follow-up period. During the treatment period, weekly visits are designed to accommodate weekly administration of Aldurazyme (laronidase).

Study duration for each participant will be a total of 29 weeks which will include 2 weeks of screening, 26 weeks of treatment period and 1 week of follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Chinese participants have a documented diagnosis of MPS I confirmed by measurable clinical signs and symptoms of MPS I and fibroblast or leukocyte IDUA (iduronidase) activity \<10% of normal.
* Participants have to be able to stand independently and walk a minimum of 5 meters in 6 minutes.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  * Is not a woman of childbearing potential (WOCBP).
  * OR
  * Is a WOCBP and agrees to use an acceptable contraceptive method during the intervention period and at a minimum until 7 days after the last dose of study intervention.
  * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the screening period before the first dose of study intervention.
  * If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  * Contraceptive/barrier method is not applicable for male participants.

Exclusion Criteria:

* Prior tracheostomy or bone marrow transplantation or hematopoietic stem cell transplantation.
* Have a plan to undergo bone marrow transplantation or hematopoietic stem cell transplantation within half a year after enrollment.
* Received an investigational drug, or device, other than Aldurazyme, within 30 days prior to study enrollment.
* Received an investigational gene therapy.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
* Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

Exclusion Criteria:

* Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
* Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
* Individuals who have ingested \> 4 grams of acetaminophen/day in any of the previous 7 days.
* Individuals \< 18 years of age.
* Individuals with abnormal liver function at baseline (defined as AST or ALT \> 120 IU/L, International Normalized Ratio \[INR\] \> 1.5, and a-GST \> 7.5 7 :g/L).
* Individuals who have an allergy or sensitivity to acetaminophen.
A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics

This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and pharmacokinetics profile.

This is a randomized, open-label, three-arm study. The participants will be enrolled and randomized in a ratio of 1:1:1 to receive 5.0g, 7.5g, 10g b.i.d. of MZRW at 9 am respectively. The study drug, MZRW will be administrated to the participants by site personnel after participants have fasted overnight for more than 8 hours and 6 hours after administration. Each participant will consume a standardized meal. In addition, the participants refrain from Semen Cannabis Sativae, Semen Pruni Armeniacae, Radix Paeoniae, Fructus Immaturus Citri Aurantii, Cortex Magnoliae and Radix et Rhizoma Rhei foods for 3 days before the study until completion of the study.

Blood samples (5 ml each) will be collected from the medial cubital vein into evacuated tubes containing heparin just before and at 0.25, 0.5, 1, 2, 4, 8, 12h after administration and were immediately centrifuged (1700g, 10 min). Plasma fractions were stored at -20°C until analysis. All study procedures conduct in accordance with the ethical principles of the Declaration of Helsinki, consistent with Good Clinical Practice guidelines, and approved by Hong Kong Baptist University Ethics Committee on the Use of Human Subjects for Teaching and Research. Subjects will be given their written informed consent before participating in the study. Urine samples (50 ml each) will be collected the day before the administration and at 0 to 3h, 3 to 6h, 6 to 9h and 9 to 12h after administration. Plasma and urine fractions will be stored at -80°C until analysis.

Eligibility Criteria:
Healthy voluteers
Rhinoplasty Scar Comparison

Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent skin sutures. These sutures create less inflammation and are thought to lead to improved final scar outcomes. However, permanent sutures require removal which creates pain and inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require removal. The difference in final scar outcome based on suture material used has not been well studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured with traditional permanent suture compared to fast absorbing suture. If scar outcomes are similar between these groups as judged by the patients and blinded observers, rhinoplasty surgeons may be able to preferentially utilize absorbable sutures for incision closure and avoid the pain and inconvenience for the patient during suture removal


Eligibility Criteria:
Inclusion Criteria

•Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons.

Exclusion Criteria

* Patients undergoing rhinoplasty for cleft nasal deformity or nasal reconstruction related to cancer resection
* Patients with previous surgery that involved a columellar incision. Patients with history of previous nasal surgery that did not involve an incision on the columella may be included
* Patients with known history of cutaneous disorder that affects scaring such as personal history of keloid formation, collagen vascular disease, or previous radiation to the surgical site
* Inability or unwillingness of subject to give informed consent
Patient Satisfaction After Switching to Oral Testosterone Undecanoate

The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
2. Males between 18 and 65 years of age.
3. Documented diagnosis of testosterone deficiency.
4. Prior treatment with testosterone therapy at the time of enrollment with adequate control of low testosterone symptoms. Serum total testosterone \< 300 ng/dL on 2 measurements prior to the initiation of testosterone therapy. Patients must have completed an adequate washout period following prior testosterone therapy (4 weeks for gels and injection based therapies and 16 weeks for subcutaneous pellets).
5. Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. History of significant sensitivity or allergy to androgens or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \> 19 points.
4. Body mass index (BMI) ≥ 40 kg/m2.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

   1. Baseline hemoglobin \> 16 g/dL
   2. Hematocrit \< 35% or \> 50%
6. Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) \>150 or Diastolic Blood Pressure (DBP) \> 90 on two separate measurements
7. Concurrent use of any prohibited medications that can affect testosterone levels or metabolism.
8. History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
9. History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
10. History of stroke or myocardial infarction within the past 5 years.
11. History of, or current or suspected, prostate or breast cancer.
12. History of, or current or suspected, pituitary abnormality.
13. History of diagnosed, severe, untreated, obstructive sleep apnea.
14. History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
15. Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
16. Inability to understand and provide written informed consent for the study.
17. Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.

Study design:

Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.

Eligibility Criteria:
Inclusion criteria:

* Screening Visit

  * Age: 19-80
  * High risk for cardiovascular disease according to NCEP APT III
  * TG≥130mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
  * 500mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
* Baseline Visit

  * 500mg/dL\>TG≥200mg/dL
  * LDL-C\<110mg/dL
  * Reduction of LDL-C dompairng screening visit

Exclusion criteria:

* The patient has histories of acute artery disease within 3 months
* The patient has histories of operation revasculatiation or aneurysm within 6 months
* The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
* The patient has histories of Effectable disease to the procedrue and clinical trial result
Posterior Fossa Mutism on Quality of Life

Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism 1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few patients recover normal speech. Most of their speech continues to be marked by dysarthria, dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies have looked at long term outcomes of patients affected by PFM. We propose to survey patients who developed PFM after resection of a medulloblastoma to determine long term effects of PFM on patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

Patients must be between 8 years and 25 years of age at the time of enrollment and have completed treatment for their initial diagnosis of medulloblastoma.

Exclusion Criteria:

1. Patient is less than 8 years old or greater than 25 years old at the time of the administration of the survey.
2. Patients are too ill to complete the survey as identified by their treating physician.
3. Patients who are unable to speak or understand English.
4. Patients who are currently being treated for their original diagnosis of medulloblastoma.
Alternative Antibiotic Regimen in Periodontitis Treatment

Context and Aims: Several studies have demonstrated an association between obesity, periodontitis, and exercise. This study aimed to investigate the effects of regular exercise on obese women with periodontal disease, using serum, saliva, and gingival crevicular fluid (GCF) samples.

Settings and Design: A before-after study design was adopted to evaluate the effects of 12 weeks of regular exercise on obese women grouped according to periodontal status, without a control group (no exercise).

Methods and Material: The study sample comprised fifteen patients without periodontitis (NP group) and 10 patients with chronic periodontitis (CP group), from whom periodontal parameters were measured and serum, saliva, and GCF samples were collected. Body mass index (BMI), anthropometric measurements, somatotype-motoric tests, and maximal oxygen consumption (VO2max) were recorded at baseline and after exercise.

Statistical analysis used: MedCalc was used for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* The periodontal diagnosis of participants with generalized periodontitis stage III-IV/grade C. Systemically healthy participants with generalized periodontitis were enrolled if they were between 18 and 40 years of age, and had no allergies to penicillin, metronidazole or quinolones, a history of antibiotic therapy or periodontal therapy within the preceding six months

Exclusion Criteria:

* Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status, allergies to quinolones, penicillin or metronidazole, a history of antibiotic therapy, or periodontal treatment within the preceding six months
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either PV or ET as defined by the 2008 World Health Organization (WHO) Diagnostic Criteria
* Requires treatment for PV or ET, in the opinion of the study investigator
* Intolerant of, resistant to, or refuses current or available treatment for PV or ET
* Direct bilirubin ≤ 2.0 x upper limit of the normal range (ULN)
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
* Calculated creatinine clearance (CrCl) of ≥ 45 mL/min
* Life expectancy \> 24 weeks
* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Females who are nursing must agree to discontinue nursing before the first dose of study drug
* Able to comprehend and willing to sign informed consent form

Exclusion Criteria:

* Prior splenectomy
* Uncontrolled intercurrent illness, per protocol
* Known positive status for human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
* Myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of study drug
* Anagrelide within 7 days prior to the first dose of study drug
* Presence of peripheral neuropathy ≥ Grade 2
* Unwilling or unable to take oral medication
* Prior use of a JAK1 or JAK2 inhibitor
* Use of strong CYP3A4 inducers within 1 week prior to the first dose of study drug
* QTc interval \> 450 msec, unless attributed to bundle branch block
Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus.

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
* Age between 18 and 85 years.
* Confirmed tongue-pharyngeal nerve injury by electromyography.
* Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia.
* Normal higher brain function, able to cooperate with treatment.

Exclusion Criteria:

* Brain vascular disease diagnosed.
* Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders.
* Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease.
* Esophageal obstruction and severe liver or kidney dysfunction
* Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.