cyrilzakka/clinical-trials huggingface dataset:
Reduction of Intrapartum Fever With Intravenous Acetaminophen

The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in laboring patients by either an oral or intravenous (IV) route. The investigators want to see if the maternal fever will decrease faster with the IV or the oral dose. The investigators also want to look at other outcomes such as the cesarean section rate, the rate of neonatal intensive care unit admissions in both groups.

This is a randomized, controlled, study of intravenous (IV) acetaminophen (OFIRMEV) versus orally administrated acetaminophen for the reduction of intrapartum maternal fever and fetal tachycardia. Compared to oral acetaminophen, intravenous acetaminophen has increased bioavailability and more rapid onset of action. IV acetaminophen has been used successfully in the management of fever in post-operative patients. Additionally, intravenous acetaminophen has also been used in the intrapartum setting for management of pain.However, the use of intravenous acetaminophen for the treatment of maternal temperature and subsequent fetal tachycardia, has not yet been evaluated.

The study will have two arms that will be randomized in a 1:1 ratio. A double dummy, double blind, comparator controlled study design will be utilized. After inclusion criteria have been satisfied, subjects in the control arm will receive an oral dose 1000 mg acetaminophen and an intravenous placebo resembling Ofirmev. The subjects in the experimental arm will receive 1000 mg of IV Ofirmev and an oral placebo resembling acetaminophen. Both groups will receive standard obstetrical care, continuous fetal monitoring, and antibiotics if there is suspected chorioamnionitis. The blinding technique will eliminate provider bias.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius.

Exclusion Criteria:

* Exclusion Criteria: Infants delivered before 36 week gestation, stillbirths, congenital fetal anomalies, scheduled cesarean deliveries, and acetaminophen allergy
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA) and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our results suggest that both continuous spinal anesthesia and combined spinal epidural anesthesia provide good surgical conditions with a low incidence of complications. The sensory block level and hemodynamic changes were lesser with CSA.

240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly assigned to receive either CSA or CSE. Blocks were performed in the lateral position at L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor block, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and post dural puncture headache were registered. At the end of the surgery, the catheter was removed and CSF leak was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Fractures repair of femur, or arthroplasty of either knee or hip

Exclusion Criteria:

* Hypovolemia
* Preexisting neurologic disease
* Coagulation disorders and/or administration of thromboprophylaxis less than eight hours before the start of surgery
* Infection at the puncture site
* Agitation or delirium and the presence of a urinary bladder catheter.
Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

The aim of the present study is to investigate a targeted proteomic analysis in plasma of children - of Greek origin- with type 1 diabetes (DT1) and its correlation with the electrophysiological findings that accompany diabetic peripheral neuropathy.

Diabetic neuropathy is the most frequent chronic complication in adults with DT1 and rarely appears in childhood. Nevertheless, cases of acute mononeuritis have been described at the time of diagnosis of DT1. According to recent reports several biomarkers, including proteomic analysis, have been proposed for the early detection of peripheral neuropathy in children and young adults with T1DM.

In the present study the researchers will attempt to investigate the role of biomarkers with targeted proteomic analysis in the plasma of children with DT1 in combination with an electrophysiological study, which includes a nerve conduction study, to detect early diabetic peripheral neuropathy, before the appearance of clinical manifestations.


Eligibility Criteria:
Inclusion Criteria:

1. Children with confirmed DT1 under insulin substitution therapy
2. Age 5-10 years
3. Good glycemic control with HbA1c ≤ 7.0%
4. Prepubertal patients
5. Absence of other diseases
6. Signed informed consent of the parents or guardians of patients

Exclusion Criteria:

1. Presence of organic cause for neuropathy
2. Presence of other chronic disease
3. Poor glycemic control

3. Medication
Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?

This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients.

The aim of the current study is to investigate whether motor training in chronic stroke patients can change their abnormal flexion synergy. The investigators will study chronic stroke patients , who are defined as patients that sustained a stroke at least 6 months prior to our testing date.

Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC), finger dexterity, and hand posture.

Prior to intervention, participants will have a baseline assessment including clinical tests, MVC, the individuation task, and the configuration task. Following the baseline assessment patients will receive intervention, training on the configuration task for 5 consecutive days. On the sixth day and as a one week follow-up after, subjects will have a post-intervention assessment containing the same tests performed in baseline.

This design will allow us to determine speed and accuracy during the configuration task, the individuation index, and possible changes in abnormal flexion synergy.

We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided to make it one arm due to the number of participants we were able to recruit.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* Ischemic stroke greater than six months ago, confirmed by CT or MRI
* Residuals unilateral upper extremity weakness
* Ability to give informed consent and understand the tasks involved.
* Appearance of Flexion synergy in hand.
* Ability to extent finger at least for 5 degrees.

Exclusion Criteria:

* Cognitive impairment, with score on Montreal Cognitive assessment (MoCA) ≤ 20
* History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease)
* Contraindication to tDCS (deep brain stimulators or other metal in the head, skull defect, pacemaker)
* Inability to sit in a chair and perform upper limb exercises for one hour at a time
* Participation in another upper extremity rehabilitative therapy study or tDCS study during the study period
* Terminal illness
* Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments
* Pregnancy
* Severe Neglect
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients

This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol

Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed oral squamous-cell carcinoma
* Age \> 17 years
* Signed informed consent
* ECOG Performance status 0-2
* Must be able to start RT within 4 weeks after PET/CT simulation

Exclusion Criteria:

* stage IV disease diagnosed before acquisition of staging PET/CT
* prior radiotherapy to oral and neck
* Unable to understand study participation
* Claustrophobia
* pregnant or breast feeding mothers
Danish Lung Cancer Screening Trial (DLCST)

The trial is a randomised trial comparing annual CT screening for lung cancer with no screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 % (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological effects of screening including the effects of false positive diagnoses, and 3) to evaluate possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of Interior and Health.

The trial is a parallel randomized controlled trial comparing either a yearly low dose CT scan or no screening. It is scheduled to enroll 4000 smokers and former smokers, and the study is scheduled to last 5 years, i.e. an initial (prevalence) screening is followed by 4 annual (incidence) screenings.

In addition the following investigations are done: A prospective, longitudinal questionnaire assessment of enrolled participants who have received a false positive diagnosis. The questionnaire will focus on the consequences of receiving a false positive diagnosis. Answers from enrolled subjects who have received a false positive diagnosis will be compared to their own "baseline" responses, and responses from subjects who have received a negative result of their own low-dose CT scans All participants will annually be questioned regarding smoking habits, their motivation for cessation of smoking and will be advised to refrain from smoking to assess the effect of participation in a screening protocol for lung cancer on cessation of smoking.

Socioeconomic consequences of screening for lung cancer will be assessed by longitudinal registration of costs and benefits (e.g. morbidity, hospitalization, GP consultations etc.

Assess the value of PET scanning when screening for lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Smoking exposure \> 20 pack years
* Quit smoking \< 10 years
* Fit to undergo treatment
* Pulmonary function test \> 30 % of expected (FEV1)

Exclusion Criteria:

* Bodyweight \> 130 Kg
* Formely treated for lungcancer, breastcancer, melanoma or hypernephroma.
* Serious co-morbidity with life expectancy below 10 years.
* Treated for other malignant diseases within the last 5 years.
* Treatment for pulmonary tuberculosis within the last 2 years.
Enhancing Knowledge Translation in Nutrition Through a Healthy Eating Blog

The purpose of this study is to determine if a nutrition intervention provided through a healthy eating blog is feasible and acceptable.

Participants randomised to the experimental group are exposed to one blog post each week for a period of 6 months. Blog posts focus on the improvement of fruits and vegetables consumption targeting four main determinants of the behavior: (1) knowledge; (2) attitude; (3) self-efficacy; and (4) motivation/goals. Each post included a step-by-step recipe developed by the research team and featuring fruits and vegetables. Recipes were described textually and also using pictures and/or video. Twenty-six posts were created over the six-month intervention. Participants randomised to the control group are not exposed to the healthy eating blog. Feasibility (compliance, dropout and participation rates) and acceptability (satisfaction) of the study were assessed.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18 and older;
* with Internet access as well as an active e-mail address;
* consuming five or less servings of F\&V per day;
* living in the Quebec City metropolitan.

Exclusion Criteria:

* women dieting,
* currently pregnant or lactating.
Registry for Pancreatic Cancer

This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer

Exclusion Criteria:

* Younger than 18 years of age
Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer

Health establishments encourage the development of specific care pathways for the elderly by supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a clear reduction in mortality and the number of re-hospitalizations in patients 6 months after their care. The multidisciplinary approach of global management of the patient in the perioperative period aims to reduce surgical stress as well as the rapid restoration of previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved rehabilitation after colorectal surgery, care programs are not specific to the geriatric population and geriatric assessment criteria to describe the functional status of patients are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment following colorectal surgery, on the evolution of several clinical parameters such as: functional status, morbidity mortality, quality of life, and lifestyle. The study investigators hypothesize that management in the GPOU for colorectal cancer surgery in patients aged 70 and over will improve functional status at 3 months, in comparison with traditional management. The proposed intervention should also lead to an improvement in patient satisfaction with care, complications and re-hospitalizations, nutritional status, lifestyle and patient survival.


Eligibility Criteria:
Inclusion Criteria:

* The patient or their representative must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Diagnosis of proven colorectal cancer.
* Patient to benefit from scheduled colorectal surgery at the University Hospital of Nîmes validated in digestive surgery SPC after oncogeriatric evaluation.
* Surgical act: resection with anastomosis in one step.

Exclusion Criteria:

* Interventional RIPH patient defined as category 1 if there is interference with the primary endpoint
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Study Conducted Among Patients With CML

Retrospective, non-interventional observational cohort study conducted among patients with CML.

A retrospective, non-interventional cohort study was used to address the study objectives. A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database) to have a better understanding of real-world treatment patterns, HRU and healthcare costs among patients with CML treated with later lines of therapy (i.e., third line or later).

For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental Databases were used (commercial claims). The commercial claims covered the period from 01/01/2001 to 06/30/2019.

The study consisted of the following periods:

* The baseline period was defined as the 6-month period before the first line therapy initiation for CML.
* The observation period was defined as the period of at least 12 months from the first CML diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Eligibility Criteria:
Inclusion Criteria:

Patients were selected for the analysis of later lines of therapy in commercial claims (i.e., were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs) if they met the following criteria:

* Had at least one diagnosis for CML, with first CML diagnosis observed in claims on or after May 10, 2001, the date of FDA approval for imatinib
* Were at least 18 years of age as of the first CML diagnosis
* Started a first line therapy for CML with imatinib, dasatinib, nilotinib, or bosutinib (conditional on FDA-approval dates)
* Initiated first line therapy within a maximum of 1 month prior to the first diagnosis for CML or a maximum 3 months following the first diagnosis for CML
* Had continuous health plan enrollment (pharmacy and medical benefits) from the washout period to at least 12 months following the first CML diagnosis

Exclusion Criteria:

* Patients had a diagnosis for CML remission or relapse anytime prior to first line therapy
* Patients had a medical claim associated with a clinical trial during the washout period up to the end of the observation period
* Patients had an HSCT during the washout period up to the first line therapy initiation
* Patients had chemotherapy treatment (except hydroxyurea) during the washout period up to the first line therapy initiation
Dietary Fiber Mixture in Constipated Pediatric Patients

The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the treatment of chronic constipation and on the colonic transit time in children.

In spite of an increase in the consumption of fibers being indicated for the treatment of constipation, few clinical trails have evaluated its efficiency. In the majority of prior studies only the effect of a single type of fiber was evaluated. Each type of fiber presents a particular characteristic, which determines its action mechanism and performance in different parts of the colon. Therefore, theoretically, greater effectiveness could well be observed when different types of fibers are associated into a single product for fiber supplementation.

A randomized, parallel, double-blind, controlled was performed to evaluate the effect of a dietary fiber mixture in constipated pediatric patients.

Children aged between 4 and 12 years were included in the study and the initial diagnosis of functional chronic constipation was made in accordance with the Rome III criteria. The children having attended the Pediatric Gastroenterology Ambulatory of the Federal University of Sao Paulo and the Santa Casa de Misericórdia hospital in Sao Paulo city. All of the children were undergoing constipation maintenance treatment with the use of a laxative in a dosage less than 1.0 ml/Kg for milk of magnesia, mineral oil or lactulose or less than 0.5 g/Kg for polyethylene glycol 3350.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 4 and 12 years;
* Maintenance treatment using low dose of laxative;
* A family with the socio-economic culture that would make it possible to carry out the procedures of the study's protocol.

Exclusion Criteria:

* Children with organic cause constipation such as Hirschsprung disease, cerebral paralysis, anorectal and spinal medulla abnormalities and metabolic illnesses;
* The regular use of a fiber supplement during the 4 weeks prior to admission;
* The use of medications that would cause constipation;
* Absence of a fixed or mobile telephone in order to make contact.
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

Efficacy and Safety from a high-dosed sublingual grass pollen preparation


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation Test

Exclusion Criteria:

* Serious chronic disease
* other perennial allergies
Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon.

A secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.

The UTMDACC family history database will be queried for the presence of cases meeting the above criteria (attenuated Familial Adenomatous Polyposis (FAP), classical AFP \[i.e. identifiable APC mutation\], and/or a compatible family history or personal adenoma burden of \> 50 adenomas).

The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery will be collected through chart review and all data is retrospective as of February 15, 2016.

The University of Texas MD Anderson Cancer Center (UTMDACC) medical record number for these cases will be used to identify the patient in ClinicStation: 1) records of endoscopy procedures, 2) operative reports, and 3) associated clinic notes will be reviewed for: a) whether the above evaluation criteria have been met, b) age, c) gender, d) age at initial colonoscopy, e) total number of colonoscopies, f) number of adenomas identified, g) cancer diagnoses, h) chemopreventive medications, i) type of surgery, j) number of hospitalizations, k) length of hospital stay, l) identification of an underlying APC mutation, and ll) family history information. The UT MDACC family history database will also be reviewed for updated family history information including ampullary adenomas and outcomes of genetic testing for identified cases.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with either a genetic diagnosis of AFAP/FAP (i.e. an identifiable APC gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of \> 50 adenomas are to be included.

Exclusion Criteria:

1. Participants who do not have with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP).