cyrilzakka/clinical-trials huggingface dataset:
Exercise and Nutrition Interventions During Chemotherapy K07

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.


Eligibility Criteria:
Inclusion criteria (subjects must...)

1. Be female
2. Have breast cancer
3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
4. Have at least six months life expectancy according to the patient's oncologist or designee
5. Be able to read English
6. Be at least 18 years old (no upper limit on age)
7. Provide written informed consent

Exclusion criteria (subjects must not...)

1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.

Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)

1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
IgM-Enriched Immunoglobulin for Neonatal Sepsis

This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS). In addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.

This randomized-controlled trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia aims to determine the efficacy of prophylactic IgM-Enriched IVIG in preventing EONS. A total of 70 very low birth weight (VLBW) neonates with risk factors for EONS including maternal factors of premature rupture of membrane (PROM), fever, urinary tract infection (UTI), chorioamnionitis, and neonatal factor of prematurity and resuscitation history will be collected. These neonates within 1 hour of life will then be administered either placebo or IgM-enriched IVIG 0.25g/kg/day for 3 days, in addition to first-line empiric antibiotic. Randomization is done using simple randomization. Triple masking (Participant, Investigator, Outcomes Assessor) is conducted.

These neonates will then be clinically observed and evaluated for early mortality (mortality below 7 days), hemodynamics, length of stay, blood culture results, C-Reactive Protein (CRP), IT ratio, routine hematological examination, and IgGAME as parameters of improvement and prevention of EONS.

STATA version 12 (Macintosh version) will be used for data management and statistical analyses. The variables will first be presented descriptively, continued with bivariate and multivariate analysis. Bivariate analysis will be conducted between independent and dependent variables using chi-square/Fisher's exact test, Student's t-test, and Kruskal-Wallis. Variables with p-values \<0.25 will be included in the multivariate analysis using logistic regression. The investigators will use two-sided p-values in our analysis with a p \< 0.05 level of significance.

Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants (\< 1500 g)
* Gestational age below 32 weeks
* Risk of Early-Onset sepsis from maternal and neonate factors
* Inborn neonates

Exclusion Criteria:

* Birth weight \< 600 g
* Gestational age \< 26 weeks
* Multiple Congenital Anomaly
* Neonates with suspected congenital syndrome
The Lake Nona Life Project

The Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance.

The Lake Nona Life Project is a community health and wellness research project of the Lake Nona Institute (LNI), carried out by the Lake Nona Medical City Residents and Partners (the Researchers), and sponsored by Florida Hospital. The project is designed to study patterns, predictors and strategies for improving human health and wellness. Data will be obtained over many years using surveys/interviews, medical tests, and health information from 3rd parties (i.e., health care claims data) obtained with participant permission.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Live and/or work in the Lake Nona Community (proper)
* Able to provide informed consent
* Able to speak and read English

Exclusion Criteria:

* Unable to speak or communicate in English
* Living outside of the LNLP study map
* Cognitive impairment that would not allow survey completion
* Unable to speak and read English
Effects of Epi-no Device on Pelvic Floor Dysfunctions

Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. EPI-NO is a device with the objective of preparing and training the pelvic floor for normal childbirth, this training allows smooth and slow movement along the perineal structures in the prenatal period, by causing a rapid traumatic laceration during childbirth. The objective of this study is to verify the effect of 10 pelvic stretching rows with Epi-No in preventing urinary incontinence and dyspareunia 6 months after delivery. The study group will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will be evaluated before the intervention and 6 months after delivery. The control group will be evaluated only once, in the sixth month after delivery. The evaluation will consist of: anamnesis, physical examination (vaginal examination and palpation), perineometry, International Urinary Incontinence Questionnaire (ICIQ-UISF), Visual Analogue Scale for dyspareunia; Questionnaire for assessing dyspareunia Female Sexual Function Index (FSFI). Pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. It is expected at the end of the study to prove the effectiveness of the effect of 10 pelvic lengthening graft with Epi-No in relation to the degrees of laceration and episiotomy and, consequently, reduction of urinary incontinence and dyspareunia.


Eligibility Criteria:
Inclusion Criteria:

* primiparous
* single fetus

Exclusion Criteria:

* Patients with complaints of urinary incontinence during or before pregnancy
* hypertension and gestational diabetes
* placenta previa
* twin pregnancy
* multiparous
* patients who had undergone perineal or vaginal surgery
* patients who had urinary tract infection, genital herpes or ongoing candidiasis
* And any other diagnosis in which pregnancy becomes at risk.
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets

The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

The Intervention Group

1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
2. Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
3. A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
4. For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
5. At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.

Control Group:

1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
2. The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
* Documented diagnosis of dementia or suspected major neurocognitive disorder.
* Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
* Have a LAR able to sign the consent on behalf of the patient.

Exclusion Criteria:

* Severe pain likely to be exacerbated by use of weighted blanket
* Inability to remove blanket;
* Skin burns or open wounds;
* Admitted on 72 hour hold.
Respiration Gated Laser Guided CT Lung Nodule Biopsy

The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).


Eligibility Criteria:
Inclusion Criteria:

Patients with indeterminate lung nodules referred from the department of pulmonary medicine at Gentofte Hospital, Denmark for a CT guided biopsy are considered for inclusion in this study. The biopsy was preformed as part of regular clinical work up of the patient at the department of Radiology Gentofte Hospital, Denmark. Both men and women were included and no age restrictions were applied.

Exclusion Criteria:

Excluded from biopsy were those with poor pulmonary function test with a forced expired volume in the first second (FEV1) \< 0.5 L, INR\>1.2, blood cloth level under 200\* and ECG with sign of ischemic heart disease. The trial is planned to begin 1.March 2010 and run for 2 years ending at 29 February 2012. During this time approx. 400 participants planned for biopsy are accepted to be included in the trial.
Eight-week Effect of the Sit-to-stand Test on Muscle Architecture.

An 8-week intervention of the sit-to-stand test (STS) of 5 and 10 repetitions will be performed to two randomly selected groups to compare its effect on the muscle architecture of the vastus lateralis muscle.

H1: 10 STS significantly modifies vastus lateralis muscle architecture in adults compared to 5STS and the control group.

Participants will be required to attend the laboratory for a first familiarization visit, where descriptive, biometric, and medical variables will also be evaluated. In addition, during this first familiarization session, it will be previously determined if the participants present any exclusion criteria and their muscle architecture will also be evaluated. After the familiarization session and the participants have signed the informed consent form, they will be randomly assigned to a 5 STS, 10 STS, or control group. Each group (exception of the control group) will be asked to perform three times a week one of the STS modalities assigned to them for 8 weeks, to ensure that the test is completed correctly and also to maintain the planning, the evaluator will be connected virtually with the participants, where rest times will be controlled and a fatigue perception scale will be performed at the end of each session, which will allow controlling the process each session. Subsequently, participants will be asked to attend the laboratory to re-evaluate their architectural parameters ( pennation angle, fascicle length, and muscle thickness) of the quadriceps muscle, one week after performing the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults, over 18 years of age.
* They must have signed the informed consent form.
* Who can perform the STS.
* In case of suffering from a chronic non-communicable disease, that it is under control.

Exclusion Criteria:

* Inability to perform the STS.
* Hypertension (\>200/110 mmHg).
* Acute neuromuscular or joint injury.
* Who have suffered a stroke in the last 6 months.
* Who have suffered a myocardial infarction or fracture in the last 6 months.
* Terminally ill.
* People who practice a sport professionally.
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated

Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study
The Fluid Translation of Research Into Practice Study

Translating reliable evidence on fluid resuscitation of intensive care patients into clinical practice - Improving patient outcomes and containing public health costs

The Fluid-Translation of Research into Practice Study (TRIPS) is an international, single day, cross-sectional study planned for the second quarter of 2014, coordinated by the George Institute for Global Health, with the purpose of documenting prescribing practices for fluid resuscitation in intensive care units (ICUs) worldwide. This international cross-sectional study follows on from the publication of large-scale randomized controlled trials and meta-analyses of fluid resuscitation, which provide evidence of how fluid resuscitation may affect patient-centered outcomes.

Fluid-TRIPS is a repeat of the Saline versus Albumin for Fluid Evaluation (SAFE)-TRIPS which was an international cross-sectional survey conducted in 2007 that had 391 ICU's participate from 25 countries and provided insight into international fluid resuscitation practice at that time. Along with establishing if fluid resuscitation practices have changed since SAFE-TRIPS, Fluid-TRIPS also aims to determine the relationship between fluid choice and evidence, along with understand other factors that may influence the choice of bolus fluid in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Adult patients present in the ICU on the study day or admitted during the 24-hour study period will be included in the study sample.

Exclusion Criteria:

Children under 16 years are excluded
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.


Eligibility Criteria:
Inclusion criteria:

1. Male or female aged 18 years and over.
2. International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
4. History of at least moderate migraine pain intensity, if left untreated.

Exclusion criteria:

1. Headache symptoms which may be due to or aggravated by:

   * Recent (within 6 months) head or neck trauma (e.g., whiplash)
   * Head or neck pain secondary to an orthopedic abnormality
   * Cluster headache
   * Specific migraine variants (e.g., basilar-type artery migraine, ophthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
   * Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)
   * Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
2. Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
3. History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.

Other protocol-defined inclusion/exclusion criteria may apply
Integrase Inhibitor (MK-0518) Viral Decay

The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).

The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be HIV-1 infected
2. Participant must be 18 years old
3. Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
4. Participant must have a VL \< 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of \< 100 copies/ml that the study investigator deems to be not clinically significant
5. Female participant must agree to use two methods of birth control or abstinence during the period of the study
6. Participant has to have signed full informed consent

Exclusion Criteria:

1. Participant who would have difficulty participating in a trial due to non-adherence or substance abuse
2. Participant who has taken mono or dual antiretroviral therapy in the past
3. Participant who has had a VL \> 50 copies/ml on any antiretroviral regimen
4. Participant with any of the following abnormal laboratory test results in screening:

   * Hemoglobin \< 100 g/L
   * Neutrophil count \< 750 cells/L
   * Platelet count \< 50,000 cells/L
   * AST or ALT \> 5X the upper limit of normal
   * Creatinine \> 250 mol/L
5. Participant with a malignancy
6. Participant with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
7. Participant with an active AIDS-defining illness in the past six months
8. Participant who is pregnant
The Relation Between Common Carotid Artery Diameter and Central Venous Pressure for Assessment of Intravascular Fluid Status After Major Surgeries: An Observational Study

Recently, bedside ultrasound has become an important tool for the simple and non-invasive hemodynamic assessment of critically ill patients. This applies not only to echocardiography but also to ultrasound of large extra-thoracic veins. The sonography can provide real time assessment of the vascular system and hemodynamic status at the bedside.

To our knowledge, there is one report about the association between sonographically assessed carotid artery diameter and intravascular volume, which raised recommendation for further studies including the interplay between carotid geometry and intravascular fluid status.

Aim of the study:

The aim of this work is to evaluate the accuracy of noninvasive techniques for assessment of intravascular volume status by Sonographic assessment of both the common carotid artery diameter (CCA) and the central venous pressure (CVP) in response to a bolus of crystalloid solution infusion and to find the correlation between CCA diameter and CVP as the primary outcome in adults patients after major surgeries who needs close assessment and maintenance of the intravascular volume status.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients (age 20-60 years).
2. ASA physical status I and II
3. Patients who are able to breathe spontaneously and lie supine.
4. Patients who have CVP catheter (subclavian or internal jugular vein).

Exclusion Criteria:

1. History of carotid artery surgery
2. Significant cardiac disease (cardiomyopathy and/or moderate to severe valvular heart lesion).
3. Significant hepatic disease (Child-Pugh score B or C ).
4. Renal failure.
5. Obesity: BMI ˃ 30 kg/m2
6. Need for mechanical ventilation.
7. Pregnancy.
8. Unstable vital signs during the process of sonography (e.g. the patients on vasoactive drugs)