cyrilzakka/clinical-trials huggingface dataset:
Gabapentin to Treat Itch in Patients With Liver Disease

In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied.

There are some funds to cover travel expenses for patients who are not from New York (NY).

Gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available.

Double-blind, randomized, placebo-controlled study of gabapentin for the pruritus of cholestasis. Duration: 4 weeks. Some travel funds available for patients from out of the NY area for all the visits. Hospitalization at baseline and after 4 weeks of treatment. One outpatient department visit at week 2.

All patients have to be referred by their physician, who will receive a summary of the results at the end of the patient's study participation.

If patients are randomized to active drug and respond to it with decrease in pruritus, a one week supply of medication is given. The referring physician could prescribe the drug for long term use. If the patient is randomized to placebo they can be treated with active medication provided by the study for 4 weeks, at end of which, the drug could be prescribed by referring physician if the patient responds to the drug with decrease in the pruritus.

Eligibility Criteria:
Inclusion criteria include:

* Patients from ages 18 to 80 with chronic pruritus secondary to liver disease

Patients must have:

* a normal chest X- ray during the previous year
* normal thyroid function tests (treated thyroid dysfunction is acceptable)
* controlled diabetes, if diabetes mellitus is present
* negative fecal occult blood within the previous year

Exclusion criteria include:

* history of hepatic encephalopathy
* decompensated liver disease as suggested by ascites and history of variceal bleeding
* malignancy
* inability to practice contraception
* pregnancy
* creatinine \> 1.7 mg/dl
* hemoglobin \< 10mg/dl
* S/P liver transplantation
* HIV infection
Quantification of Myocardial Fibrosis in Aortis Stenosis

This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.

Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.

Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.

There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Part of the initial cohort that were included in the baseline study
* Still able to undergo protocolled investigations
* Patients: Mild, moderate or severe AS

Exclusion Criteria:

* Renal insufficiency
* Previously myocardial infarction (ECG, echocardiogram or hospital record)
* Severe valvular heart disease (except patients)
* Other cardiac disease known to cause myocardial fibrosis
* Severe hypertension
* Other medical conditions deterring protocolled investigation and follow-up
* Other medical conditions affecting 5-years prognosis (cancer, pulmonary disease)
* Severely reduced image-quality (echocardiography and MRI)
Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic

The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.

Millions of women will give birth during the pandemic of Coronavirus Disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The consequences of COVID-19 for pregnant women and their offspring are unknown. This lack of information leads to anxiety among pregnant women, women who are considering getting pregnant, and their families. It is therefore important to assess the wellbeing and mental health of women during the COVID-19 pandemic.

The international nature of the online survey will allow the evaluation of how living during the COVID-19 pandemic affects pregnant and recently pregnant women at a global level, including the evaluation of potential cultural and geographic differences.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women or women who have been pregnant within the last 6 months
* Able to give electronic informed consent

Exclusion Criteria:

* \<18 years of age
Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)

The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.

The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial.

Participating centres are selected based on previous experience with the use of the EVADO system.

Patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened.

This study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.

Eligibility Criteria:
Inclusion Criteria:

patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria:

* Written informed consent
* Age 18-85 years

Exclusion Criteria:

* Severe renal or liver failure
* Uncompensated diabetes
* Autoimmune disease requiring immunosuppressant therapy
* Coagulation disorders
* Emergent or redo surgery
Taiwan Diabetes Registry

To Investigate the Risk Factors, Life Style and Treatments of the Microvascular Disease，Macrovascular Disease and Neuropathy in Patients With Diabetes.

At the first year (2015), the patients ever enrolled into the quality control study by Taiwan Association of Diabetes Educators in 2006 and 2011 will be recruited, and their relevant clinical data will be regularly registered yearly until 2030. In addition, it is planned that type 1 diabetic patients will be enrolled, and their clinical data will be regularly recorded yearly until 2030. Also, newly diagnosed type 2 diabetic patients will be recruited, and their clinical data will be regularly entered to the diabetes web-based system yearly until 2030. We will also include pregnant patients with diabetes since 2023, and their data will be monitored and followed until 2030. Finally, we will also include pregnant patients with diabetes since 2023, and their data will be monitored and followed until 2030.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus

Exclusion Criteria:

* Patients who do not have diabetes mellitus
* Participating in an interventional trial requiring informed consent
Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders

The current study included the singleton pregnancies (without history of previous risk factors), had their homocysteine measured as part of a serum-screening program in addition to uterine artery Doppler. Sensitivity, specificity, positive and negative predictive values, for development of preeclampsia and other adverse pregnancy outcomes were assessed as follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler with a mean RI \>0.5, all unilateral notches with a mean RI \>0.6, in addition, absence of notches with a mean RI \>0.7; (3) Doppler assessment combined with the homocysteine cutoff (6.3 µmol/l).

These participants had uterine artery Doppler investigations, as part of a routine scan between the 18th and the 22nd week of pregnancy. The investigators were blinded to the results of the biochemistry results.

All samples of the tHcy measurement were collected between 15 and 19 weeks of gestational age, as calculated from the last menstrual period or from early ultrasound dates (when the menstrual dates differed from the specified gestation). The plasma tHcy concentrations were measured by means of a fluorescence polarization immunoassay (9).

Uterine artery flow velocity waveforms were obtained using an SD 800 Doppler system (Philips Medical Systems, Gland, Switzerland) with a 3.5/5-MHz linear array probe. The high-pass filter was set at 100 Hz. One operator performed the measurements. The use of mean resistance index (RI) cutoff points with bilateral and unilateral notches has already been shown to improve the efficacy of uterine artery Doppler screening using qualitative assessment (10). A screen-positive or abnormal result was defined as bilateral notches and a mean RI \>0.55 (50th centile), unilateral notches and a mean RI \>0.65 (80th centile), and absence of notches and a mean RI \>0.7 (95th centile) (11). Women with these abnormal results were offered growth scans, amniotic fluid volume assessment, and umbilical artery Doppler every 4 weeks until 36 weeks in view of the recognized increased risk of isolated IUGR (12), unless there were other clinical indications, which necessitated closer surveillance

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous pregnancies without history of previous risk factors for preeclampsia

Exclusion Criteria:

* multiple pregnancy, non-intact renal function, and hypertension before 20 weeks of gestation, diabetes mellitus and/or chronic diseases, women taking folic acid supplementations, women using antifolate drugs, and maternal age more than 40 years
Assessing the Fit of Motivational Interviewing by Cultures With Adolescents

Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment, particularly among justice-involved youth. Despite the level of research that has been conducted on motivational interviewing (MI) with mainstream samples, no published studies have investigated the efficacy of this brief, individual intervention with Hispanic adolescents. The overarching objective of this application is to evaluate the efficacy of a brief individual intervention (MI) for problem drinking behaviors with a sample of justice-involved Hispanic and Caucasian adolescents to determine if this intervention is differentially effective between Hispanic and Caucasian adolescents. Specifically, the first aim is to determine whether an MI intervention targeting alcohol abuse is effective at reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The second aim is to examine whether the effects of MI on problem drinking outcomes (e.g., alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic versus Caucasian adolescents. Because it is important to determine the mechanisms that mediate the effects of MI and determine whether these mechanisms differ between Caucasian and Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian) moderates the mediational linkages in the overall model using a cross-groups approach to moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI interventions (one at baseline and a second, one week later) or an education condition. All adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed research is expected to take a significant step towards reducing current racial/ethnic health disparities in alcohol treatment for Hispanic adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 - 18
* Provision of informed assent (or self-consent if age 18)
* Parent/ guardian consent if under age 18
* Regular substance use (use at least 1 per month for past 6 months)

Exclusion Criteria:

* active psychosis
* mental retardation
* neurodevelopmental disorder
* severe medical illness
Telomerase Activator and Retinal Amyloid

A method of detecting amyloid in the retina has been developed. A specially designed retinal camera will directly visualze and record retinal amyloid and via image processing will generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates with cerebral amyloid and has a predictive value in Alzheimer's disease.

Telomere attrition accounts for cellular aging and is felt to have a pivotal role in Alzheimer's disease. The investigators plan to screen individuals to select those having retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter the RAI over time compared to placebo.

Telomerase Activation - Retinal Amyloid Study

Telomere attrition has been linked to the neurodegenerative disease Alzheimer's disease (AD). AD is definitively diagnosed at autopsy a fact that has prompted exhaustive investigations looking for reliable biomarkers of AD. It is known that the clinical signs of AD are the end result of years of accumulation of an aggregated protein substance, amyloid. The retina is part of the brain and recently, a diagnostic technology has been developed that allows detection of retinal amyloid. Tissue studies show a correlation between retinal and cerebral amyloid, and it has been proposed that early detection of retinal amyloid, long before clinical dementia, may offer an opportunity for intervention to slow or halt progressive amyloid deposition. Special imaging technology has been developed that is capable of detecting retinal amyloid via an adapted retinal camera. Neurovision Imaging (NVI) is the company that has developed these testing technologies: both for retinal amyloid detection and measurement.

A study is proposed that will investigate if there is a measurable treatment effect of the telomerase activator TA-65 on retinal amyloid of the participants. It is anticipated that recruiting will primarily be directed at adult children of individuals with clinical AD.

The study will include 50 participants and will have a term of 12 months; it is anticipated that up to 300 individuals will be screened to acquire the participants. The study will be conducted at a single site: Chippewa Valley Eye Clinic, Eau Claire, Wisconsin and/or its satellites. TA-Sciences will sponsor the study, provide telomere length testing on saliva samples collected at the start and conclusion of study. TA-Sciences will also provide active and placebo product for term of study.

Eligibility Criteria:
Inclusion Criteria:

* qualifying retinal amyloid index (RAI) number as determined at screening
* Must be able to swallow capsule

Exclusion Criteria:

* Cancer treatment within 5 years (except non-melanoma skin cancer)
* Must be able to swallow capsule
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis

This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, \>/= 6 years of age
* Confirmed diagnosis of cystic fibrosis (CF)
* Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months prior to screening
* Percent predicted FEV1 \>/= 40% at screening based on the Wang (males \< 18 years, females \< 16 years) or Hankinson (males \>/= 18 years, females \>/= 16 years) standardized equations
* Able to reproducibly perform spirometry testing and comply with study assessments

Exclusion Criteria:

* An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization
* Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization
* Changes in chest physiotherapy schedule within 4 weeks prior to randomization
* Hospitalization within 4 weeks prior to randomization
* Planned hospitalization during the 6-week study
* History of organ transplantation
* Participation in an investigational drug or device study within 30 day prior to screening
A Phase 1b Study to Evaluate the Safety of XEN-101

This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity

This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18 to 60 years, inclusive, at Screening
2. Body mass index of 30 to 45 kg/m2
3. Stable body weight for at least 3 months (i.e., fluctuation of ≤5%)
4. If a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the ICF, throughout the study, and for 4 weeks after the final dose of study drug. In addition, she must be advised not to donate ova during this period. If a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the ICF, throughout the study, and for 8 weeks after the final dose of study drug. In addition, he must be advised not to donate sperm during this period
5. If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline)
6. Able to provide informed consent
7. Willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between Screening for this study and the end of the Treatment Period of the previous investigational device or drug study
2. Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D \>3 years before Screening is allowed)
3. Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
4. Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the Investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation
5. Female who is pregnant, nursing, or intends to become pregnant during the study.
6. Positive result for hepatitis B virus surface antigen, hepatitis C virus ribonucleic acid, and human immunodeficiency virus (HIV) antibody at Screening
7. Use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before Screening
Emollient Therapy for Premature Infants in Zimbabwe

The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.

For infants whose parent/caretaker provides written informed consent, the study nurse coordinator on-site will allocate infants to one of two strata (700- \<1000 g or 1000-1500 g). Participants within each stratum will be randomly assigned in a 1:1 ratio to one of two treatment groups: 1) high-linoleate SSO, or 2) standard-of-care treatment without use of topical emollients or massage.

Eligibility Criteria:
Inclusion Criteria:

* infants \<72 hours of age
* weigh 700-1500 at birth
* hospitalized at SMCH

Exclusion Criteria:

* infants who are moribund and highly likely not to survive despite any intervention
* significant breaches in their skin barrier
* conditions indicating failure to gain weight
* critically ill (definition below):

  1. Oxygen saturation \<88% on oxygen therapy AND ≥2 of the following conditions:
  2. respiratory rate \<20 or \>100 breaths per minute
  3. apnea requiring bag-mask ventilation
  4. heart rate \<100 or \>200 beats per minute
* congenital syphilis
* hydrops fetalis
* a life-threatening congenital anomaly or major surgical condition requiring intervention
* generalized skin disease or a structural defect involving \>5% body surface area likely to produce a defect in epidermal barrier function