cyrilzakka/clinical-trials huggingface dataset:
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients

The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).

A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level. During Study Period I, all the subjects will be given a once daily (QD) injection of lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study Period II) will receive three times daily (TID) injections of insulin.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having type 2 Diabetes.
* Patients who have not been on insulin treatment within 6 months.
* Patients who have been taking OADs for at least 90 days.
* Patients with an HbA1c level in the range of 7.5% to 11.0%.
* Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

Exclusion Criteria:

* Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
* Patients having or suspected of having malignancy
* Patients having serious complications of the heart, liver, or kidney.
* Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
* Patients receiving systemic steroids.
* Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
* Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
Evaluation of Dynamic Stability in the Low Back Pain Patient

The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax, an indicator of local dynamic stability) of chronic low back pain patients versus that of healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low back pain patients).

The secondary objectives of this study are:

To compare lmax in the different experimental conditions within each group (chronic lower back pain patients, healthy volunteers).

To compare changes in lmax for low back pain patients at D7 and 6 weeks.

Eligibility Criteria:
General inclusion criteria:

* The patient/subject must have given his/her informed and signed consent
* The patient/subject must be insured or beneficiary of a health insurance plan

Inclusion criteria for low back pain patients:

* The patient has chronic low back pain lasting for more than 6 months and which is not postoperative in nature

General exclusion criteria:

* The patient/subject is participating in another study
* The patient/subject is in an exclusion period determined by a previous study
* The patient/subject is under judicial protection, under tutorship or curatorship
* The patient/subject refuses to sign the consent
* It is impossible to correctly inform the patient/subject
* The patient/subject is pregnant, parturient, or breastfeeding

Exclusion criteria for low back pain patients:

* The patient has a history of spinal surgery
* The patient has a history of preexisting postural disorder related to lumbalgia
* The patient has undergone a localized infiltration treatment (e.g. cortisone shots) in the last month
* The subject has a balance disorder, blindness, inability to carry out the experimental protocol

Exclusion criteria for healthy volunteers:

* The subject has a history of acute low back pain \> 15 days or which has resulted in a work stoppage of more than 7 days in the 5 years preceding the study
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder

The goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes.
* urinary incontinence (urge or predominantly urge) by clinical criteria.
* able to accurately complete a voiding diary, to perform a 24-hour pad test under direction.

Exclusion Criteria:

* significant mental impairment \[mini mental status exam (MMSE) ≤ 20)
* urethral obstruction
* history of bladder cancer
* spinal cord lesions
* multiple sclerosis
* pelvic radiation
* interstitial cystitis
* artificial sphincter implant
* expected to have changes in medications/doses during the trial
* medically unstable
* Patients with factors that could cause transient UI \[e.g., current urinary tract infection (UTI), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
* conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B

The purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis B infection.

LB80380, an oral prodrug, is a promising candidate nucleoside analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection and for treatment of lamivudine-resistant disease.

In this study, the treatment period was divided into two parts: a 4-week treatment period with dose escalation assessment (Part 1), followed by an 8-week extension period (Part 2).

During Part 1, patients received LB80380 and LVD 100 mg once daily for 4 weeks. Each patient was then given only LB80380 for an additional 8 weeks (Part 2) unless dose-limiting toxicity (DLT) was observed during Part 1. At each dose level, all patients were to complete at least Part 1 of the treatment period before enrolment into the next Dose Group could commence. Dose escalation to the next group was not to be initiated if more than two patients experienced DLT during Part 1 in the previous Dose Group. Additionally, patients enrolled in LB80380 150mg and 240mg groups who agreed to participate in the pharmacokinetic (PK) analyses visited the study site the day before Week 12 for blood sampling. Follow-up period was 24 weeks, and patients were treated with adefovir dipivoxil during the follow-up period. During the study, patients were evaluated for changes from baseline in serum HBV DNA. Safety was evaluated on the basis of occurrence of AEs and changes from baseline in clinical laboratory parameters, physical examination findings, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Compensated chronic hepatitis B patient
* Presence of serum HBsAg for more than 6 months.
* Presence of HBeAg for more than 1 month with compensated liver disease
* Confirmation of YMDD mutants (M552V, M552I and its related double mutant at L528M) by genotyping of the YMDD motif using line probe assay (INNO-LiPA HBV DR assay)
* Screening HBV DNA value higher than or equal to 1,000,000 copies/mL (measured by the COBAS Amplicor HBV Monitor™ assay)
* Screening ALT value between 1.5 and 10 x ULN

Exclusion Criteria:

* Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
* Pregnancy or breast-feeding
* Previous treatment with nucleoside analogue or any other treatment for HBV except for lamivudine within 6 months prior to study entry
* Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
* De-compensated liver disease
* Screening alpha-fetoprotein (AFP) value \> 20 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC.
* Presence of anti-HBs at screening
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma

This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer.

This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.

■ Examination Methods

* FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
* FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
* Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
* Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Suspected patients of urothelial cancer who will visit the National Cancer Center Korea from the date of Institutional Review Board (IRB) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy.
* Subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study

Exclusion Criteria:

* History of other active malignant tumors treated within 24 months
* Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
* If patients and guardians do not want to participate in this study
* History of having administered FGFR inhibitors in the past
A Study of JNJ-73763989 in Healthy Chinese Adult Participants

The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy based on physical examination, laboratory assessment, vital signs and electrocardiogram (ECG) at screening
* A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[hCG\]) pregnancy test at screening and a negative urine pregnancy test on Day -1
* A male participant must agree not to donate sperm after enrollment (Day 1) in the study and a female participant must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after receiving the study drug
* Participant must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening until completion of the study
* Participant must have suitable veins for cannulation and/or repeated venipuncture

Exclusion Criteria:

* Participant with a history of cardiac arrhythmias (example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Participant with human immunodeficiency virus infection (confirmed by antibodies) at screening
* Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening
* Participant has positive test result(s) for alcohol and/or drugs of abuse (including amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, and methadone) at screening and Day-1
* Participant has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments. This may include but is not limited to renal dysfunction estimated Glomerular Filtration Rate (GFR) \<60 millimeter per minute (mL/min) /1.73 m\^2 at screening
Investigational MRI Clinical Software and Hardware

Patients and healthy volunteers will be scanned in order to test new sequences.

The aims of this study are to:

1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.

Eligibility Criteria:
Inclusion Criteria:

* • At least 18 years of age

  * Able to complete the MR safety questionnaire.
  * Able to comprehend and provide informed consent in English.
  * When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
  * When contrast is being administered: patients with a GFR ≥30 ml/min

Exclusion Criteria:

* • When contrast is being administered: subjects with a GFR \< 30 ml/min

  * When contrast is being administered: subjects with acute kidney injury
  * When contrast is administered, allergy to gadolinium-containing contrast media
  * Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
  * Adults unable to consent
  * Individuals who are not yet adults
  * Pregnant or breastfeeding women
  * Prisoners
Recovery Housing For Drug Dependent Pregnant Women

For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below:

1. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.
2. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
3. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).


Eligibility Criteria:
Inclusion Criteria:

* CAP enrolled
* Age 18 or older
* Evidence of use of opiate and/or cocaine use in the past 30 days
* Assigned to pharmacotherapy free modality
* CAP admission at an estimated gestational age (EGA) \<34 weeks

Exclusion criteria:

* Endorses current suicidal ideation
* Any medical disorders requiring extended or future hospitalization
* Meet diagnostic criteria for current DSM-IV alcohol dependence
* Meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
* Demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
Botox Injection in Treatment of Chronic Migraine

Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.

The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.

The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.

The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.


Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent
* Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Failed at least 3 oral migraine prophylactic treatments
* Duration of migraine at least 1 year before inclusion
* Start of migraine before participant turned 50 years
* Participant can make a distinction between migraine and other types of headache

Exclusion Criteria:

* If the criteria for medication-overuse headache (MOH) is fulfilled
* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Anomalies which hinder or impede the used method of injection
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
* Treatment with medication that can interact with botulinum toxin type A
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.

PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.

OBJECTIVES:

Primary

* Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
* Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.

Secondary

* Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
* Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients.
* Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.
* Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.

OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling.

Patients are followed at 24 hours and at 1 week.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* No metastatic disease
* No inflammatory breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No active infection or inflammation in the breast under study
* No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
* No severe illness
* Not unconscious
* No mental illness or handicap
* No nursing within the past 12 months
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior breast implantation on side of proposed lavage
* No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or other surgery that may disrupt the ductal systems within 2 cm of the nipple

  * Biopsies and fine-needle aspirations \> 2 cm from the nipple are allowed
Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question\[s\] it aims to answer are:

* If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications;
* If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation;

Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:

* Personalized positive end-expiratory pressure based on EFL
* Standard of care positive end-expiratory pressure

Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 90 years old;
* Patients undergoing laparoscopic, robotic surgery
* Surgery performed in elective regimen;
* Length of mechanical ventilation more than 120 minutes;
* Presence of invasive pressure monitoring for clinical purposes;

Exclusion Criteria:

* Age \< 18 or \> 90;
* Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
* Length of mechanical ventilation less than 120 minutes;
* Unplanned conversion to laparotomy surgery;
* Refusal to participate by the patient;
* Anesthesia maintenance using Desflurane.