cyrilzakka/clinical-trials huggingface dataset:
Bilateral Infant Stimulation Study

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

Objectives:

1. Examine the effect of a bilateral alternating stimulation (BAS) NICU intervention on parental anxiety and psychological distress in the NICU using biological and self-report measurements.
2. Examine the effect of a bilateral alternating stimulation NICU intervention on infants' physiological stress response after parental engagement in the BAS intervention with the infant.

This is a pilot study of bilateral alternating stimulation (BAS) examining the effectiveness as a therapeutic intervention for parental and infant stress in the NICU. It is a single arm design. Participants include parents and their infant that is currently admitted to the NICU. All participants will engage in parent-neonate intervention session, following this, infants will complete a delayed comparison arm (control session) with the interventionist. Infants currently admitted to NICU will be screened for eligibility, and if eligible, the families will be approached for enrollment. Families that enroll will be scheduled for one study session. During study session, parents will wear a heart rate monitor, complete psychologic scales of anxiety, stress, and feelings of closeness to thier infant, parents will be trained on the intervention and then engage in the intervention with their infant. Continuous vital signs will be collected for infant throughout the study session. After the intervention, parents will complete psychologic scales and satisfaction scales. Infants will then be scheduled for follow-up session where an interventionist will engage infant in intervention and vital signs will be collected throughout.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the NICU at the time of study
* greater than 34 weeks gestational age and less than 43 weeks gestational age
* within 4 weeks of admission to NICU at time of initial contact
* have parent or legal guardian willing and able to participate in the study

Exclusion Criteria:

* those who are less than 3 days postop from surgical procedures
* current use of psychotropic medications or medications that affect the central nervous system (CNS)
* CNS anomaly.
Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)

The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.

Specific goals:

* Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain
* Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain
* Investigate effects of weight gain and dietary fat composition on markers of vascular health

Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* Body Mass Index 18-27

Exclusion Criteria:

* Liver disease,
* Coronary heart disease,
* Diabetes mellitus,
* Malignant diseases,
* Alcohol or drug abuse,
* Magnetic Resonance-incompatibility,
* Abnormal clinical chemistry,
* Use of drugs that significantly effects energy metabolism,
* Heavy exercise,
* Pregnancy or lactation,
* Allergy of gluten, egg or milk protein
OPSCC N0 Nodal Control With Reduced IMRT

The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.

The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.

Eligibility Criteria:
Inclusion Criteria:

* patient must be clinically referred for radiation for stage I-IVb OPSCCA
* tumor must be HPV-associated p16+
* patient must be able to lie flat and tolerate immobilization systems

Exclusion Criteria:

* patients may not be receiving any investigational agents
* prior radiation to head and neck
* any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
* any major medical, psychiatric, or neurologic illness
* pregnant or breastfeeding women
Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) was a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL-CTSC cohort and will examine whether vitamin D or fish oil supplementation has beneficial effects on cellular aging.

This project is an ancillary study based on the parental study "the VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259)" at the Harvard Clinical and Translational Science Centre (CTSC) and Brigham and Women's Hospital. Our research focuses on the separate and synergistic effects of vitamin D and omega -3 supplements on telomere length, a cellular aging marker, using de-identified samples from VITAL-CTSC cohort.

Aims: 1) To test the hypothesis that vitamin D supplementation decreases leukocyte telomere length attrition. The investigators will determine the effect of vitamin D supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 2) To test the hypothesis that marine omega-3 fatty acid supplementation decreases LTL attrition. The investigators will determine the effect of marine omega-3 fatty acid supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 3) To determine to what extent the effects of vitamin D or omega-3 supplementation on inflammatory cytokines and CVD risk factors are mediated by telomere length attrition over time; 4) To explore the synergistic effects vitamin D and omega-3 fatty acid supplementation.

Eligibility Criteria:
Inclusion Criteria:

The subcohort of 1,054 participants in VITAL (NCT 01169259) who are receiving detailed health assessments at a Clinical and Translation Science Center at Boston are eligible to participate in this ancillary study:

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Exclusion Criteria: None

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Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma.

Retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus Gemcitabine between December 2013 and June 2015 according to the routine practice. Overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.

This observational, retrospective, multicenter study included patients with metastatic pancreatic adenocarcinoma (either recurrent or de novo) from 20 Spanish hospitals, who started first-line chemotherapy with nab-paclitaxel (Abraxane®, Celgene Europe Limited) plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. The record included all adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,\[15\] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine. Data were retrieved from patients' medical records and lasted until death or the closure of the database on 16 March 2017. All patients signed the corresponding informed consent for their clinical data being used in this study, which was conducted in accordance with the local personal data protection law (LOPD 15/1999). The study protocol was approved by the local independent ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites.
* Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
* No prior chemotherapy for metastatic pancreatic cancer.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
* Age greater than or equal to 18 years.
* Patient has signed a Patient Informed Consent Form.
* Patients should have received at least one cycle of gemcitabine and nabpaclitaxel

Exclusion Criteria:

* less than one cycle of gemcitabine/nabpaclitaxel administrated.
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B

This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
* Subjects with HBsAg-Positive diagnosed at the screening visit
* Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
* For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10\^5 copies/ml
* For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10\^5 copies/ml
* Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon

Exclusion Criteria:

* Subjects with HCV, HDV or HIV
* Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
* With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
* Less than 50ml/min of creatinine clearance diagnosed at the screening visit
* More than 50 ng/ml of alpha-fetoprotein at the screening visit
* Involved in other studies
The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

Importance: The problems of side effects of metabolic disturbances in schizophrenic patients have been of worldwide concern for some time. Patients with dyslipidemia have an increased risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment of dyslipidemia.

Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics.

Design, Setting, and Participants: A longitudinal case-control study was used in a general hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy adult subjects, who were all hospital workers, were enrolled in this study.

Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six months.

The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has always been a cause for global concern and discussion. Although Hawthorn is widely used in the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there are several areas of interest in the present study: 1) the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing factors that relate to changes in lipid profile levels in patients who take Hawthorn.

Eligibility Criteria:
Inclusion Criteria:

* Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* All participants in the case group had previously received antipsychotic treatment for a period of time.

Exclusion Criteria:

* Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample
* Participants were pregnant and lactating women in both group, were excluded.
Combined HCC-MFCCC

Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).

The institutional prospectively maintained database was queried, and 20 patients with cHCC-MFCCC were identified. A 2:1 match was performed with 40 patients operated in the same period for HCC, and with 40 operated for MFCCC. Only T1 or T2 patients N0 M0 were considered. Primary endpoint was the overall survival (OS) and disease-free survival (DFS).

Eligibility Criteria:
Inclusion Criteria:

* positive histology for cHCC-MFCCC, HCC, and MFCCC
* complete clinical, surgical, pathological and follow-up data.

Exclusion Criteria:

* patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded.
* patients operated for recurrent disease and/or with non-radical surgery
* patients with missing data were also excluded
A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers

The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* BMI between 18 and 30 kg/m2 and Weight ≥ 60 Kg
* Subjects must be either surgically sterilized (vasectomy), or if their partner is of childbearing potential, must use two methods of contraception, one of which must be a barrier method, from the first dose until 3 months after the last dose
* Subject is able and willing to comply with the requirements of the protocol

Exclusion Criteria:

* History of clinically significant disease
* Any illness within the 4 weeks prior to the screening examination
* Any history of alcohol and/or drug of abuse addiction and/or active / past (up to 2 years before screening) nicotine consumption
* Clinically relevant deviation from normal in the physical examination and vital signs at screening or baseline
* Clinically relevant laboratory abnormalities identified at screening or baseline
* Positive tests at screening for HIV I \& II, hepatitis B and/or hepatitis C in both parts or positive tests for Syphilis, HTLV I \& II and Nucleic Acid Test (NAT) for HIV and HBV
* Positive test for urine drugs of abuse or by anamnesis (Barbiturates, Benzodiazepines, Amphetamines, Opiates, Cocaine, Cannabinoids, Methadone, Phencyclidine, and Tricyclic Antidepressants) and/or positive alcohol blood test
* Subjects who have lost or donated in excess of 400 mL of blood within 3 months prior to Day 1 of the study
Diet and Health in Adults with Metabolic Syndrome

The prevalence of US adults with Metabolic Syndrome (MetS) is over 34%, impacting nearly 35% of all adults and 50% of those aged 60 years or older. MetS is characterized as a combination of underlying risk factors that when, occurring together, increase the risk for chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease, stroke, and certain types of cancer, resulting in an 1.6-fold increase in mortality. According the American Heart Association, health risks associated with Metabolic Syndrome can be significantly reduced by reducing body weight and eating a diet that is rich in whole grains, fruits, and vegetables. Potatoes (e.g. skin-on white potatoes) are an excellent source of potassium, vitamin C, and vitamin B6 and a good source of magnesium and dietary fiber. In addition, the potato has greater dry matter and protein per unit growing area compared with cereals. Despite this, consumers tend to believe that potatoes are high in calories and in fat compared with other carbohydrate sources such as rice or pasta, an incorrect assumption since a potato has negligible fat and a low energy density similar to legumes. Data from short-term nutrition intervention trials, suggest that potatoes consumed as part of a low-glycemic load meal can play a role in the prevention or treatment of MetS. However, the impact of long-term potato consumption on cardiometabolic risk factors associated with MetS is not known. Therefore, there is a critical need to determine if regular (\> 4 times per week) potato consumption can improve cardiometabolic health in individuals with MetS.


Eligibility Criteria:
Inclusion Criteria:

* Resides in Northwest Arkansas
* Age 18+ years
* Metabolic Syndrome (characterized by participant having three or more of the following measurements: abdominal obesity, triglyceride level over 150 mg/dl, HDL cholesterol \< 40 mg/dl in men and 50 mg/dl in women, systolic blood pressure of 130 mm Hg or diastolic blood pressure of 85 mm Hg, and/or fasting glucose \> 100 mg/dL)
* All ethnicities
* Female and male
* Currently consuming a high glycemic load diet

Exclusion Criteria:

* Food allergies
* Dietary restrictions (e.g. vegetarian, vegan, etc.)
* Trying to lose weight in last 3 months
* Prescription medications related to heart disease or type 2 diabetes
* Fear of needles
COOL-AMI EU Case Series Clinical Study

A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less. The study objectives are to evaluate retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM System.


Eligibility Criteria:
Inclusion Criteria:

* The patient is 18 years of age.
* The patient must have symptoms consistent with AMI
* MI with ST-segment elevation
* The patient is eligible for PCI.
* The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
* The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* The patient has had a previous myocardial infarction
* The patient is experiencing cardiogenic shock
* The patient is experiencing acute pulmonary edema.
* The patient is presenting with cardiac arrest.
* The patient is presenting with Killip risk stratification class II through IV.
* The patient is presenting with Atrial Fibrillation.
* The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
* The patient requires an immediate surgical or procedural intervention other than PCI
* The patient has an aortic dissection.
* The patient has hepatic failure.
* The patient has end stage kidney disease.
* The patient is febrile
* Known chronic Congestive Heart Failure (CHF).
* Known previous CABG.
* Known recent stroke
* Cardio-pulmonary decompensation that has occurred en route to the hospital
* Contraindications to hypothermia
* The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* The patient has a known history of coagulopathy
* The patient is known to be pregnant
* The patient has a known hypersensitivity to antishivering medications.
* Patient has a known history of severe hepatic or renal impairment.
* The patient has an Inferior Vena Cava filter in place (IVC).
* The patient has a life expectancy of less than 1 year
* The patient has a known, unresolved history of drug use
* The patient is currently enrolled another investigational drug or device trial
A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark

The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments.

Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.


Eligibility Criteria:
Inclusion Criteria:

The study population will consist of all patients in Denmark who meet the following criteria:

* Adult (≥18 years) at time of anticoagulant initiation
* Diagnosed with atrial fibrillation without recorded valvular disease
* Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014).
* For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases.

Exclusion Criteria:

* Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded
Flavoring Oral Contrast for MR Enterography

To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography.

Volumen is an oral contrast agent used in MR imaging of the bowel. It has an unpleasant taste which makes it difficult for pediatric patients, especially sick pediatric patients, to drink. There are other contrast materials used in the department that are flavored to improved patient participation. The investigators hope to determine a way to flavor Volumen to improve patient participation. In doing so, the investigators hope to also improve patient satisfaction as well as imaging quality.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients having a MR enterography

Exclusion Criteria:

* sedated patients