cyrilzakka/clinical-trials huggingface dataset:
A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione

This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes for at least 6 months
* Treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
* BMI of 21-45 kg/m2, inclusive
* HbA1c level of 7.50 - 10.00%, inclusive
* If a female of childbearing potential, willing to utilize contraception from Screening through 4 weeks after the last dose of study drug

Exclusion Criteria:

* Treatment with insulin, sulfonylurea, DPP-4 inhibitors, Symlin® and/or GLP-1 analogues ≤ 3 months prior to the Screening
* Severe hypoglycemia ≤ 60 days prior to the Screening visit or currently diagnosed with having hypoglycemia unawareness
* History of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
* Previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
* Myocardial infarction within the last 2 years, current congestive heart failure with NYHA class 2 or greater, or chronic atrial fibrillation
* Current clinically significant and/or chronic illness
* Takes regular courses of non-steroidal anti-inflammatory drugs (NSAIDS). If these medications are discontinued upon starting Screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the Study
* Use of systemic corticosteroids (oral, suppository, injected). Use of inhaled or topical corticosteroids is permitted
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

Study protocol included criteria for study termination that was met when \> 2 patients lost CCyR during TFR phase (\> 1% BCR-ABL); This study was terminated early as \> 2 cases of confirmed loss of complete cytogenetic response were reported despite BCR-ABL monitoring during the TFR Phase. All cases achieved MR4.5 after Nilotinib treatment re-initiation and maintained until end of study; trial did not mandate re-initiation within 4 weeks after loss of MMR_ that was a requirement in other Nilotinib TFR trials Initial sample size was 300 patients with CML-CP; Amendment #2 in June 2015 reduced sample size to 59 due to recruitment challenges; Study endpoint analysis and interpretations of data were challenging due to small sample size for early study closure..

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CML
* Treated with at least 1 year of imatinib
* Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
* Written informed consent obtained prior to any screening procedures performed

Exclusion Criteria:

* T315I mutation
* Prior imatinib failure or had accelerated phase or blast crisis CML
* Impaired cardiac function
* Pregnant or lactating women
Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently, secondary angular fracture dislocation (defined as a difference of the angle of 10° or more from the post-operative to the follow-up x-rays) can be observed in approximately 30% of patients after conventional intramedullary nailing of proximal third tibial fractures and in approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of secondary loss of reduction by providing axial and angular stability. ASLS provides angular stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes.

The present study evaluates the handling of ASLS and the surgeon's compliance as well as any complications occurring during the baseline and the follow-up period in patients with proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails. Furthermore, the relationship of any occurred complications to ASLS will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 18 years old
* One of the following bones is fractured so that the fracture is affecting the proximal or the distal third of the bone without affecting the joint surface: Humerus, Femur, Tibia
* The fracture is fixed with one of the following cannulated implants Humerus: Expert HN, Expert PHN. Femur: Expert LFN, Expert RAFN, CFN, DFN, AFN. Tibia: Expert TN, CTN.
* The patient is willing and able to participate in the study follow-up according to the CIP.
* The patient is able to understand and read local language at elementary level.
* The patient is willing and able to give written informed consent to participate in the study.

Exclusion criteria:

* The patient is legally incompetent.
* Preexistent malunion or nonunion of the bone that is planned to be treated with ASLS.
* The patient suffers from a polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening).
* The patient suffers from active malignancy.
* The patient is affected by drug or alcohol abuse.
* The patient has participated in any other device or drug related clinical trial within the previous month.
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.


Eligibility Criteria:
Inclusion Criteria:

* Has HIV-1 infection
* Is naïve to anti-retroviral therapy (ART).
* Is clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study
* Female is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP); but if WOCBP agrees to follow the contraceptive guidance
* All participants, male and female, agree to use barrier methods of contraception when engaged in any sexual activity during treatment and for 6 weeks following treatment.

Exclusion Criteria:

* Is a user of recreational or illicit drugs or has had a history of drug or alcohol abuse or dependence that may interfere with trial participation
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs
* Has a history of malignancy ≤5 years prior
* Female expects to donate eggs at any time during the study
* Is breastfeeding or expecting to conceive
* A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment
* Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
* Requires any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan, Nafcillin, Pentostatin
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial
* Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor
* Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV co-infection defined as hepatitis B surface antigen \[HBsAg\]-positive
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has previously been randomized in a study and received islatravir (MK-8591), DOR, Doravirine, Tenofovir, Lamivudine, or 3TC.
A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Use of contraindicated medications within 2 weeks of dosing
Plasma Biomarkers of Cardiopulmonary Bypass Induced Acute Respiratory Distress Syndrome (CPB-ARDS)

The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation were observed. Plasma samples were collected before CPB, and several time points after CPB. Dynamic differential proteins of ARDS after CPB were screened by DIA (Data independent acquisition) proteomics. Quantitative protein marker concentration was used to predict the occurrence of ARDS after operation, the model discrimination and calibration was assessed.


Eligibility Criteria:
Inclusion Criteria:

* Selective operation;
* Cardiac surgery with cardiopulmonary bypass;
* Adult patients over 18 years old;
* Signed informed consent

Exclusion Criteria:

* patients who refuse to sign the informed consent form or the attending physician refuses the patient to join the study;
* non elective surgery (surgery at non-elective time or emergency surgery);
* preoperative pulmonary insufficiency, pulmonary hypertension and pulmonary inflammation;
* the absence of any specimen and clinical data;
* patients who failed the operation, needed extracorporeal membrane oxygenation support or underwent CPB operation again within 3 days after operation;
Group Psychotherapy for Adolescents With Substance Use

Background: Substance abuse among children and adolescents is an important public health issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and Family Court will cooperate in a counseling program for adolescents with illicit drug abusers in 2013, to perform a mandatory 10-week family-based group psychotherapy.

Aims: This study aims (1) to investigate the effectiveness of the family-based group psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify whether the counseling program is effective for preventing the adolescents from relapse of substance abuse.

Expected Results: The investigators expect that (1) group psychotherapy may involve comprehensive benefits for adolescents with illicit drug abusers, by improving the changes in adolescents' substance-craving symptoms and behavioral problems, and reducing stress of their parents; (2) this counseling program is effective for preventing the adolescents from relapse of substance abuse; (3) the findings in this study will not only demonstrate empirical evidence of treatment effectiveness for adolescents with illicit drug abuse, but will also provide useful clues for future implementation of policy making.

1. The investigators plan to recruit 200 adolescents (=\< 20 years) with illicit drug abusers and their parents (100 of intervention group and 100 of comparison group).
2. The intervention group consists of youths that participate in a program that combines a weekly 10-session out-patient motivational enhancement psychotherapy (MEP) program for youths with an additional weekly 10-session parenting skill training (PST) program for their guardians.
3. The comparison group consists of youths that receive standard supervision by the court. All participants were followed up for a maximum of three years.
4. The assessments for adolescents and their parents will be taken at pre- and post-treatment, using the Adolescents' Behavior-problem Scale, the Craving Beliefs Questionnaire, the Family APGAR, the Parenting Stress Index-Short From (PSI/SF) and the Chinese Health Questionnaire (CHQ).
5. The information of adolescents' relapse of substance abuse will be collected by Kaoshiung Juvenile and Family Court.

Eligibility Criteria:
Inclusion Criteria:

* The adolescents with illicit drug age between 12 to 20.
* One of their parents can attend the counseling program.

Exclusion Criteria:

* The adolescents or their parents can't attend the program.
Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients

Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age.
* Patient is screened for malnutrition with an MST score ≥ 2 (see Appendix C).
* Patient has length of stay of hospital stay \> 2 days.
* Patient is able to consume foods and beverages orally.
* Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital stay in connection with the QIP.

Exclusion Criteria:

* Patient is pregnant.
* Patient is intubated, receiving tube feeding or parenteral nutrition.
* Patient unable to provide HIPAA authorization and informed consent.
* Patient is discharged to hospice care.
* Patient has a condition that would preclude ingestion / absorption of the oral nutritional supplements, including allergic response to any ONS ingredient.
* Patient has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder.
* Patient has stated an allergy or intolerance to any of the ingredients in the study products.
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.


Eligibility Criteria:
Inclusion Criteria:

- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 \[NCT02408523\]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative

Exclusion Criteria:

* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
* Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has \>=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%). For all subjects who entered EP0012 directly with a Baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.

The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last dose of rocuronium. Determining this relationship will enable the provision of advice on when it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
* between the ages of 18 to 64 years, inclusive
* scheduled for a surgical procedure under general anesthesia requiring

neuromuscular relaxation with the use of rocuronium

* scheduled for a surgical procedure in supine position
* have given written informed consent

Exclusion Criteria:

* participants with a difficult intubation because of expected anatomical

malformations

* known or suspected to have neuromuscular disorders impairing

neuromuscular blockade and/or significant hepatic and/or renal

dysfunction

* medical or physical condition that is expected to interfere

with the proper conduct of simultaneous neuromuscular monitoring on

both arms

* known or suspected to have a (family) history of malignant

hyperthermia

* known or suspected to have arthritis or another disease that will

cause the thumb not to move freely

* known or suspected to have an allergy to narcotics, muscle

relaxants or other medication used during general anesthesia

* is receiving medication in a dose and/or at a time point known to

interfere with neuromuscular blocking agents (NMBAs), such as antibiotics, anticonvulsants and Mg2+

* already participated in a sugammadex trial
* participated in another clinical trial, not pre-approved, within prior 30 days
* pregnant females
* breast-feeding females
Dilute Versus Concentrated Epidural Bupivacaine in Labor

This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine.

We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.

This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (PCEA).

Eligibility Criteria:
Inclusion Criteria:

* nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation

Exclusion Criteria:

* narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
Temporal Changes of Lactate in CLASSIC Patients

This study aim to examine if randomization to different treatment strategies had any effect on the time to normalization of lactate in intensive care patients treated for septic shock.

This is a retrospective analysis of a subset of patients included in the Conservative versus Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial.

In the CLASSIC trial patients with septic shock were randomized to either traditional (liberal) strategy for fluid treatment or a more conservative regimen. The study was an international multicenter clinical trial (clinicaltrials.gov NCT03668236), and results were published in New England Journal of Medicine in June 2022 (DOI: 10.1056/NEJMoa2202707).

In this substudy the investigator extract all lactate values for the study period from all patients included from Karolinska University Hospital, Sundsvall and Södersjukhuset (Sweden), participating centers on Zealand (Denmark), and Plzen University Hospital (Czech Republic). Baseline data, treatment allocation and amount of fluids administered are collected as well as outcome from CLASSIC study.

Primary outcome is time to lactate normalization (\< 2mmol/L). Secondary outcome is lactate concentration over the first 72 hours (as peak lactate for the time intervals 0-3, 3-6, 6-12, 12-24 and then each 12h-period between 24 and 72 hours).

The subgroup with blood lactate \> 4mmol/L will be analyzed separately for the same end points.

Time to resolution of hyperlactatemia will be modelled with a competing risks regression. Death and discharge will be competing outcomes, and administrative censoring imposed 72 hours after randomisation.

Factors associated with time to lactate normalization will be examined through regression analysis. Factors that show a relationship on univariate analysis will be included in a multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Participation in CLASSIC trial in any of the participating centres

Exclusion Criteria:

* Lack of sufficient data for analysis