cyrilzakka/clinical-trials huggingface dataset:
Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers

Patients with lung disease experiencing difficulty breathing can be treated with oxygen therapy. This involves the delivery of "extra" oxygen by a face-mask or through small tubes placed in the nose called nasal prongs. This extra oxygen can have concentrations as high as 100% pure oxygen. The concentration of oxygen in normal air is only 21%. The high concentration of oxygen can help to provide enough oxygen for all of the organs in the body. Unfortunately, breathing 100% oxygen for long periods of time can cause changes in the lungs, which are potentially harmful. Researchers believe that by lowering the concentration of oxygen therapy to 40% patients can receive it for longer periods of time without the risk of side effects.

This study is designed to evaluate the effects of oxygen therapy at 100% and 40% for 12 18 hours on the lungs of normal volunteers. Results of this study will help to determine if levels of oxygen therapy currently accepted as being "safe" may actually be damaging to the lungs.

Stress such as high oxygen or inflammation can result in damage to proteins by processes such as oxidation or alternative regulation of signaling pathways by post-translational modification of proteins (e.g., phosphorylation). Delivery of oxygen in high concentrations to the lungs can result in damage, which is mediated in large part by reactive oxygen species. Inflammation can result in activation of intracellular signaling pathways. This study will evaluate modification of proteins and nucleic acids in bronchoalveolar lavage fluid, bronchial epithelial cells, and peripheral blood of individuals exposed to oxygen or who are smokers. In doing so, it will determine the effects of hyperoxia or inflammation on the lung.

Eligibility Criteria:
* INCLUSION CRITERIA:

History - good overall health without history of recent (within 3 months) acute disease;

Physical examination within normal limits;

Laboratory evaluation; including complete blood count (CBC), serum electrolyte determinations, clotting times, chest x-ray, pulmonary function testing, and an electrocardiogram (EKG) - within normal limits;

Non-smokers defined as having never smoked or not smoked in the past 2 years;

Smokers defined as moderate (1 pack per day for 3+ years) or heavy (1-2 packs for 10+ years);

Subjects must be willing to make the time commitment necessary for the study.

EXCLUSION CRITERIA:

Any study subject who does not fulfill the criteria for eligibility.

Individuals with a history of allergy or adverse reactions to atropine or any local anesthetic;

Individuals testing positive for the human immunodeficiency virus or hepatitis virus;

Individuals on chronic medications or currently receiving medications;

Pregnant or lactating individuals, since the effects of hyperoxia on the fetus are unclear.
Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. On hemodialysis for more than 6 months
2. Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
3. Suboptimal nutritional status identified by:

   * Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:

     * Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
     * Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
     * Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:

       * Serum transferrin concentration less than 225 mg/dl
       * Serum prealbumin concentration less than 32 mg/dl

Exclusion Criteria:

1. Active auto-immune, inflammatory or infectious disease
2. Documented malignancy within the last 12 months
3. Patients on unusual dietary restrictions
4. Life-expectancy less than 6 months
5. Inability to tolerate nutritional supplements
A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse

In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status).

We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.


Eligibility Criteria:
Inclusion Criteria:

Patient requiring endotracheal intubation

Exclusion Criteria:

* Age \< 18 yrs
* Pregnancy
* Amputation of a lower limb
* Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs
* Patients under administrative protective measures
* Severe cardiovascular collapse before intubation
* Severe cardiogenic pulmonary oedema
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic hepatitis C
* HIV HCV co-infection allowed
* informed consent to data collection

Exclusion Criteria:

* co-infection with Hepatitis B Virus (HBV)
* previous treatment with peginterferon and/or ribavirin
The Effect of Growth Hormone in Very Young Girls With Turner Syndrome

This study investigated the effect of growth hormone on the growth of infants and toddlers with Turner syndrome during 2 years of treatment with growth hormone. This was compared with the growth of infants and toddlers with Turner syndrome who did not receive any growth hormone treatment. The overall aim was to prevent the growth failure usually seen during this period. The study also looked at middle ear disease, hearing problems, and cognitive and behavioral development.


Eligibility Criteria:
Inclusion Criteria:

* Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome.
* At least 9 months of age and not greater than 4 years of age.
* Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstick is adequate), performed prior to study entry.
* If there was a known history of hypothyroidism, then adequate thyroid hormone replacement must have been taken for at least 6 months prior to study entry.

Exclusion Criteria:

* Current or previous treatment with any therapy that may have directly influenced growth, including growth hormone, growth hormone-releasing hormone, estrogens and anabolic steroids such as oxandrolone. This included previous completion of, or withdrawal from, this study or any other study investigating therapeutic uses of growth hormone or growth hormone-releasing hormone.
* Chronic treatment with systemic glucocorticoids in supra-physiological doses.
* Treatment with potential growth-influencing medications such as methylphenidate (Ritalin), pemoline (Cylert), and amphetamines, at, or within 3 months prior to, study entry.
* Presence of any Y chromosome component in the karyotype if gonads were in situ. Subjects whose karyotype contained Y chromatin, but who had undergone gonadectomy, were eligible to enter the study.
* Presence of any additional known autosomal abnormality.
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Diagnosis of focal epilepsy.
* Previous failure of one or more AEDs used in monotherapy.
* Background treatment with an antiepileptic drug.
* The investigator has considered that the patient must start treatment with some of the seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin, oxcarbazepine, pregabalin, tiagabine and/or topiramate.
* History of seizures in the patient in the past 3 months.
* The patient or legal guardian must be able to understand the characteristics of the study and fill in the seizure diaries.
* Written informed consent.

Exclusion Criteria:

* Inability to comply with the study requirements.
* Diagnosis of generalized epilepsy or inability to establish if focal or generalized.
* Presence of serious or uncontrolled systemic disease, serious psychiatric disease or progressive neurological disease.
* History of alcoholism, drug addiction, or abuse of medicines in the past two years.
* Psychogenic seizures in the two years prior to inclusion in the study.
Laparoscopic Surgery VS RFA for Recurrent HCC

Management of recurrent HCC is urgent and several treatments have been developed .Repeat hepatectomy is considered to be the first choice for recurrent HCC.

Unfortunately, repeated open hepatectomy can be performed only in a small proportion of patients due to inadequate liver function reserve, widespread recurrence or high invasiveness. Given that recurrent tumors are usually detected at small size during follow-up after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally curative and causes minimal damage to liver function reserve,has been widely used. However, the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single center pilot studies reported that LS may, compared with open surgery, improve the prognosis of HCC with less blood loss and shorter hospital stay. LS was initially considered not suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic surgical procedure more difficult and less safe. With improvement in technique and experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. However, thus far, no study has been performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare those results to that for RFA. To clarify these issues, a multicenter retrospective comparative study by using propensity score matching method that included a large consecutive series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was performed.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. First recurrent HCC after curative hepatectomy;
3. A solitary recurrent HCC ≤ 3.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
4. Tumor located in left lateral lobe (segment II or III) or subcapsule of liver(subcapsular nodule was defined as a lesion located less than 1 cm from the liver edge and could be treated by either LS or RFA.
5. No radiologic evidence of invasion into major portal/ hepatic vein branches;
6. No extrahepatic metastases;
7. Child-Turcotte-Pugh class A or B;

Exclusion Criteria:

1. Coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3);
2. History of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
3. History of a secondary malignancy;
4. Severe dysfunction of the heart, kidney, or other organs
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table

Exclusion Criteria:

1. Patient refusal
2. Patients that are not normal sinus rhythm on preoperative ECG
3. Patients with moderate\~severe cardiac valve disease
4. Patients with an ejection fraction under 50%
5. Significant lung disease
6. Obesity (BMI\>35kg/m2)
7. Patients with contraindications to esophageal doppler probe insertion
8. Illiterate patients or foreigners
Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Eligibility Criteria:
Inclusion Criteria:

* subjects are healthy population older than 15 years.
* subjects are willing to give signed informed consents.
* subjects are willing to give blood samples on recommended days.
* subjects are available for follow up according to the table of administration

Exclusion Criteria:

* subjects who had received any type of rabies vaccination in the past
* subjects who had received rabies immunoglobulin in the past
* subjects who had known as immunocompromised hosts
* subjects on steroids or any other immunosuppressant
* subjects on concomitant antimalarials
* subjects who have received of any blood products within the previous 3 months
* subjects with history of allergy to any ingredient of the vaccine
* subjects who had known as pregnancy in first recruitment
Depression Treatment and Risk for Cardiovascular Disease

This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.


Eligibility Criteria:
Inclusion Criteria:

Males and females age 21-75

Meet diagnostic criteria for major depressive disorder

Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.

Levels of depressive symptoms of at least moderate level (beck depression inventory II score \> 19 of 63 possible points; or a Hamilton depression rating scale \> 12 of 50 possible points)

Exclusion Criteria:

A verbal expression of current, significant, suicidal ideation; a score of \> 15 on the beck scale for suicidal ideation

Score of \>1 on any single item of the Beck Scale for Suicidal Ideation

Score of \> 1 on the item assessing suicidal ideation on the beck depression inventory II.

Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)

Current use of an antidepressant medication

Currently in psychotherapy.

Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent

Diagnosis of CVD.
Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
* Patients who have suitable cord blood units for dUCBT
* Patients with ECOG performance status 0-1
* Patients with adequate organ function: lung, kidney, liver, heart, etc.
* Informed consent

Exclusion Criteria:

* Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
* Patients who have anti-HLA antibodies
* Patients with any evidence of central nervous system (CNS) involvement of disease
* Patients with uncontrolled diabetes
* Patients with uncontrolled hypertension
* Patients with any evidence of active infection
* Positive for human immunodeficiency virus (HIV)
* Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
* Women who are pregnant or breastfeeding
* Patients with previous history of allogeneic stem cell transplantation
* Patients with major psychotic disorder or drug/alcohol abuser
* Inappropriate patients according to the investigators' opinion
New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations

This mixed methods study evaluates the effectiveness and cost of a healthcare worker focused outreach intervention strategy versus community organization led outreach to explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability.

In Aim 2, the investigators conduct a mixed methods study to evaluate the effectiveness and cost of: (1) the healthcare worker focused outreach intervention strategy versus (2) community organization led outreach working with community based organizations. The investigators explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability. The primary outcome is uptake of COVID-19 testing using the novel Rutgers Clinical Genomics Laboratory/RUCDR saliva test, the first FDA authorized diagnostic test using saliva to detect SARS-CoV-2 for non-invasive, home based self-testing. To compare participation rates in the two arms, our primary outcome, the investigators will use data on the number of tests performed per month up to a 12 month study period. For each intervention, the start time is the date of first attempted contact with potential participants and the end date is either the end of the study period, or the date at which the 1000th individual was tested (whichever comes first).

Eligibility Criteria:
Inclusion Criteria for Community Members and Healthcare Workers

* Self-identification as Black or Hispanic/Latino.
* Resident of Union, Passaic, Middlesex, or Essex County, NJ.
* Parent/legal guardian able to provide permission to participate for those under 18

Exclusion Criteria:

* Under 4 years of age.
* Unable to speak, understand, and/or read English or Spanish.
* Unable to provide informed consent/assent
Impact of Neuropsychological Evaluation on Epilepsy Treatment

The present study aims to expand the evidence base of neuropsychological services in the context of medical management of epilepsy, examining whether treatment outcome and patient satisfaction with medical care are significantly improved when neuropsychological evaluation is included as an additional component of medical care within a comprehensive epilepsy center. All participants will complete an initial survey and a follow-up survey regarding views towards their epilepsy treatment. Participants will be randomized into one of two groups. One group will be given a neuropsychological battery in addition to the survey. The primary study hypothesis is that the addition of neuropsychological services to treatment-as-usual will result in significant improvements in (a) satisfaction with medical care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance. The secondary hypothesis is that participants who undergo neuropsychological evaluation will be generally satisfied with their experience with neuropsychological services.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* experiencing some degree of epilepsy-related symptoms, but not of such severity as to preclude them from being able to provide consent or undergo neuropsychological assessment (requiring extended inpatient treatment, severely aphasic, or MMSE score \< 25)

Exclusion Criteria:

* Previously undergone neuropsychological testing
* Currently pursuing surgical treatment for epilepsy