cyrilzakka/clinical-trials huggingface dataset:
Brief Computerized Feedback for Smokers in Recovery

The purpose of this research study is to find out more about smokers in recovery from addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior feedback session. The hypothesis is that a brief computerized smoking behavior feedback session will motivate more smokers to quit smoking than a control condition.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older
2. Be in recovery from addiction to alcohol and/or drugs (self-defined)
3. Have smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
4. Have smoked at least 100 cigarettes (lifetime)
5. Have an expired air carbon monoxide (CO) level of \> 6 ppm (verifies current smoking)
6. Be cognitively able to understand the proposed research design (screening followed by random assignment to one of the two conditions, if appropriate)

To be eligible to receive NRT (if chosen by the participant), participants must:

1. Not be pregnant, breastfeeding, or plan to become pregnant in the next year
2. Not have experienced a myocardial infarction (heart attack) or have been hospitalized for a heart-related problem in the last 2 weeks
Timely Recovery After Subclinical Heart Failure

The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:

1. Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
2. The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
3. Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
4. Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.

Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.

Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure.


Eligibility Criteria:
Inclusion Criteria:

* All women who visit Maastricht Univeristy Medical Center+ for Cardiovascular screening with subclinical/asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction;
* Aged 18 years and older;
* Premenopausal women with a history of preeclamptic pregnancy and premenopausal women with a history of normal pregnancy;
* Between 0.5 and 30 years postpartum;

Exclusion Criteria:

* Intention to pursue pregnancy within 2 years;
* Already using antihypertensive medication;
* Suffering diabetes mellitus, kidney failure (GFR\&amp;lt;60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
* Breastfeeding during participation;
* Previous angio-edema
Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells.


Eligibility Criteria:
Inclusion Criteria:

\[Subjects at genetic high risk for schizophrenia\]

* Healthy without any Axis I mental disorder
* Is a monozygotic twin of a patient with schizophrenia OR Has at least two family members of schizophrenia in the pedigree, including at least one 1st-degree family member

\[Healthy Control\]

* Healthy without any Axis I mental disorder
* No family members of schizophrenia in the pedigree to the 3rd degree

Exclusion Criteria:

* Significant neurological or medical illness
* Psychotic symptoms
* Substance abuse
* Suicidal risk
* Blindness or hearing loss
* Taking aspirin, warfarin or hormonal agents
* Pregnancy or lactation
* Susceptibility for keloid formation
* Allergy to lidocaine
* History of significant head trauma or loss of consciousness
* Mental retardation
Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis

The purpose of this research study is to evaluate the safety and effectiveness of Ranolazine, and how well it is tolerated in patients with Amyotrophic Lateral Sclerosis (ALS). Ranolazine is an FDA approved drug that is used for decreasing chest pain.

Amyotrophic Lateral Sclerosis (ALS) is a progressive debilitating and fatal neurodegenerative disease involving the motor neurons in the primary motor cortex, corticospinal tracts, brainstem and spinal cord with 5,000 newly diagnosed patients per year in the USA. There is a pressing need for additional therapies, as the only two FDA-approved drugs for ALS, riluzole and edaravone, showed prolongation of median survival of only two to three months and only a modest benefit in daily functioning, respectively. The ability to identify FDA approved drugs which can be repurposed to ALS, and which may slow disease progression, alleviate symptoms, or prolong survival will have an immediate positive impact of the lives of patients with ALS and their family members. Hypothesis: Ranolazine, an FDA approved drug for angina which inhibits the late Na+ current and intracellular Ca2+ accumulation may be neuroprotective in ALS by reducing neuronal hyperexcitability, may slow disease progression and reduce cramp frequency.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically definite, probable, laboratory supported probable, or possible ALS per revised El Escorial criteria
* Cramp frequency greater than 4 cramps per week during 2 week run in
* ALS functional rating scale-revised (ALSFRS-R) score of greater than 24
* Able to lie on back for study procedures

Exclusion Criteria:

* Tracheostomy invasive ventilation, or use of non-invasive ventilation greater than 12 hours per day
* Pregnant or lactating
* Participation in a prior experimental drug trial less than 30 days prior to screening
* Patients taking ranolazine
* Patients taking medications which are contraindicated for use with ranolazine such as strong CYP3 inhibitors (ketoconazole, clarithromycin, nelfinavir), and CYP3 inducers (rifampin, phenobarbital)
* Patients with clinically significant medical comorbidities (hepatic, renal, cardiac, etc)
* Patients with baseline QT interval prolongation on Electrocardiography (ECG)
* Patients pre-disposed to secondary QT prolongation for other health conditions like family history of congenital long QT syndrome, heart failure, bradycardia, or cardiomyopathies
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)

This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density lipoprotein cholestrol (LDL-C).


Eligibility Criteria:
Inclusion criteria:

* Has a history of primary hypercholesterolemia or mixed dyslipidemia and meets LDL-C and triglyceride criteria.
* Is high risk coronary heart disease (CHD) and has LDL-C ≤190 mg/dL (≤4.91 mmol/L).
* Is not high risk CHD and has LDL-C ≤240 mg/dL (≤6.21 mmol/L).

Exclusion criteria:

* Is pregnant or breast-feeding, or expecting to conceive or donate eggs or sperm during the study.
* Has a history of malignancy within ≤5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Consumes more than 3 alcoholic drinks per day (14 per week).
* Is a high risk CHD patient on lipid modifying therapy (LMT).
* Is on any LMT with equivalent or greater LDL-C-lowering efficacy than simvastatin 40 mg.
* Has Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on statin therapy.
* Currently engages in vigorous exercise or is on an aggressive diet regimen.
* Has uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart surgery.
* Is human immunodeficiency virus (HIV) positive.
* Has taken niacin \>50 mg/day, bile-acid sequestrants, 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitors, ezetimibe, Cholestin™ \[red yeast rice\] and other red yeast products within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3).

Note: Fish oils, phytosterol margarines and other non-prescribed therapies are allowed provided participant has been on a stable dose for 6 weeks prior to Visit 2 and agrees to remain on this dose for the duration of the study.

* Is currently receiving cyclical hormonal contraceptives or intermittent use of hormone replacement therapies (HRTs) (e.g., estradiol, medroxyprogesterone, progesterone). Note: Participants who have been on a stable dose of non-cyclical HRT or hormonal contraceptive for greater than 6 weeks prior to Visit 1 are eligible if they agree to remain on the same regimen for the duration of the study.
* Is taking prohibited medications such as systemic corticosteroids, potent inhibitors of Cytochrome P450 3A4 (CYP3A4), cyclosporine, danazol, or fusidic acid.
* Consumes \>1 quart of grapefruit juice/day.
* Requires warfarin treatment and has not been on a stable dose with a stable International Normalized Ratio (INR) for at least 6 weeks prior to Visit 1.
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough

This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Cold/URTI symptoms occurring no more than 4 days
* cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
* cough frequency with specified cut-off

Exclusion Criteria:

* A subchronic, or chronic cough (cough duration \> 2 months) due to any condition other than a cold/URTI
* Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
* Taking any medications known to induce cough
* Fever of greater than 39°C (102°F) orally
* Complication of the common cold like otitis media, severe sinusitis, or pneumonia
* Other protocol-defined inclusion/exclusion criteria may apply
Antioxidant Supplements in Cystic Fibrosis Children

This randomized controlled clinical trial included 60 pediatric patients with cystic fibrosis (CF) assigned randomly into two arms; Arm 1(extra care arm):received a tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age, with antioxidant supplements in specific doses in oral liquid form (200 mg vitamin E, 300 mg vitamin C, 90 μg Se, 500 μg vitamin A, 30 mg zinc, 3 mg copper and 2000 IU vitamin D) for 6 months. Arm 2: recieved tailored dietary plan following Mediterranean diet as Arm 1 with fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K) for 6 months. This study aimed to evaluate the effect of antioxidants supplementation on the level of oxidative stress, as measured by 3-Nitrotyrosine, bacterial colonization and diseases severity among CF children.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented diagnosis of cystic fibrosis (CF) who were diagnosed according to CF Foundation guidelines based upon positive sweat tests and/or the presence of a mutation in the homozygous state or two heterozygous mutations on the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein

Exclusion Criteria:

* Patients with current pulmonary exacerbations.
* Patients with severe sepsis.
* Patients with comorbid systemic illnesses.
Role of CX3CR1-expressing Cells in Hematologic Malignancy

This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid cells in patients of hematologic malignancy.

Tumor cells either express membrane molecules or release tumor-derived soluble factors able to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an important function in the pathophysiology of various forms of cancers. Fkn is the only known ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+ myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple myeloma (MM).

Bone marrow aspirates will be obtained from newly diagnosed MM and DLBCL patients at the time of diagnosis and relapse. Peripheral blood will be obtained at the time of diagnosis, finishing treatment, 3 months after treatment and relapse.

The investigators will analyze the cell fractions of CD11b+ CX3CR1+ cells and CD3+CX3CR1+ cells in blood samples by flowcytometry. The investigators will find out the relationship between the tested cells and clinical outcome in MM and DLBCL.

Eligibility Criteria:
Inclusion Criteria:

* Subject newly diagnosed multiple myeloma.
* Subject newly diagnosed diffuse large B cell lymphoma.

Exclusion Criteria:

* History of other hematologic malignancy
* History of previous chemotherapy
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients

This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 70 years at the time of screening, inclusive
* Diagnosed with T2D and under the care of a healthcare professional for its management, or newly diagnosed (as participant in the study) with T2D
* HbA1c 6.5% -10.5%, inclusive
* Has given written informed consent to participate in this study
* Willing to complete 84-day test period
* Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study

Exclusion Criteria:

* Type 1 diabetes
* History of bariatric or intestinal surgery
* Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis
* Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
* History of heart disease that in the opinion of the investigator should exclude the subject from the study
* Severely uncontrolled hypertension at screening defined as a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
* Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
* Active significant infection as determined by the investigator
* Known allergy to butyrate or any of the components of the tablets
* Subjects planning to make major changes to diet and physical activity during the trial duration
* Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
* Pregnant, nursing, or trying to become pregnant
* In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
* Subject is taking one or more of the excluded therapies.
Long-Term Follow-up of Gene Therapy for APOE4 Homozygote Alzheimer's Disease

The primary purpose of this long-term follow-up study is to assess the long-term safety profile of APOE4 homozygote participants who were administered gene therapy (LX1001) for the treatment of Alzheimer's disease in Study LX100101. A secondary objective is to assess the biomarker as shown by the conversion of CSF APOE isoforms from APOE4 to APOE2-APOE4. Additional secondary outcomes include amyloid PET scan, CSF markers (including Aβ42, Aβ42/Aβ40 ratio T--tau, and P-tau), and quantitative MRI (and other biomarkers that may be informative for this therapeutic approach). Other secondary objectives include instruments to assess cognitive and clinical AD and to evaluate if treatment with AAVrh.10hAPOE2 improves brain tau pathology with tau PET scan (LX1001-01 Cohorts 3 and 4 only).

This is a long-term follow-up study to evaluate the safety following LX1001, a gene therapy, for participants who are APOE4 homozygotes with clinical diagnoses varying from MCI or dementia due to AD who have previously received LX1001. Study LX1001-01 was designed to assess the safety of LX1001 at 4 ascending doses (1.4 × 1010, 4.4 × 1010, 1.4 × 1011 gene copy \[gc\]/mL CSF and 1.4 x 1014 \[fixed dose\]) as per droplet digital polymerase chain reaction methodology, with each group consisting of approximately n=3-5 individuals for a total of approximately 15 participants for the entire study.

In this study, participants who have received LX1001 in the parent protocol (LX1001-01) will be followed for up to 260 weeks post gene therapy administration to assess the safety and efficacy parameters (\~208 weeks within this study)

Eligibility Criteria:
Inclusion Criteria:

* Participants who received LX1001 in study LX1001-01

Exclusion Criteria:

* Participants with any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to participant safety
* Participants who agree not to post their personal medical data in relation to this study or any study information online, including social media sites, until all participants have completed all LX1001 clinical studies, including long-term follow-up.
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial

Prolonged corrected QT interval (QTc) has been observed in about half of patients with liver cirrhosis. Marked prolongation of QTc (ie, 500 msec) has been considered to be a risk factor for fatal ventricular arrhythmia, such as torsade de pointes,7,8 which has been reported in liver transplantation (LT) surgery. In a previous study, prolonged QTc interval ( 500 msec) was frequently observed throughout the procedure of LT, even among patients with baseline QTc 440 msec. Therefore, it is important to optimize electrolyte balance and hemodynamic status to reduce greater risk of perioperative arrhythmias.

The investigators hypothesized that the change of QTc interval might be differ according to method of general anesthesia (inhalation agent vs. intravenous agent).


Eligibility Criteria:
Inclusion Criteria:

* patients with liver cirrhosis who will undergo planned liver transplantation

Exclusion Criteria:

* 1. emergent liver transplantation
* 2. unstable angina
* 3. recent MI(Myocardial Infarction)
* 4. uncontrolled hypertension (diastolic BP \> 110mmHg)
* 5. implantable cardiac defibrillator
* 6. severe obesity (BMI\>30kg/m2)
* 7. allergy to propofol
Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-III
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Do not understand our study
* Allergies to anesthetic or analgesic medications
* Wound infiltration analgesia for postoperative pain control
* Infection or anatomic abnormality at the needle insertion site
* Pregnancy/Breast feeder
* Medical or psychological disease that can affect the treatment response