cyrilzakka/clinical-trials huggingface dataset:
Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study

Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac output, which may be a concern in an already compromised fetus. Norepinephrine is commonly used in high concentrations in intensive care and recent studies have suggested that in low concentrations it may be a better alternative to phenylephrine in elective CD, as it does not reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The investigators propose this study to determine the dose that would be effective in 90% of patients (ED90).

A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately 6 µg, given that the current phenylephrine bolus dose at the investigators' institution is approximately 100 µg.

The use of norepinephrine to prevent and treat hypotension during cesarean delivery (CD) is new and data in the literature are scarce. A recent randomised controlled trial by Ngan Kee et al compared continuous infusions of norepinephrine and phenylephrine to prevent hypotension during CD. They showed that norepinephrine was effective at maintaining blood pressure, with a greater cardiac output and heart rate compared to phenylephrine. However, the effective bolus dose of norepinephrine needed to prevent maternal hypotension was not determined, and since this is a relatively new arena, no dose-response studies are available in the literature either. Therefore, it would be logical to establish the effective bolus dose of norepinephrine TO PREVENT HYPOTENSION during elective CD.

Eligibility Criteria:
Inclusion Criteria:

* Elective CD under spinal anesthesia
* Normal singleton pregnancy beyond 36 weeks gestation
* ASA physical status II/III
* Weight 50-100 kg, height 150-180 cm
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Patient refusal
* Allergy or hypersensitivity to norepinephrine or sulfite
* Preexisting or pregnancy-induced hypertension
* Cardiovascular or cerebrovascular disease
* Fetal abnormalities
* History of diabetes, excluding gestational diabetes
* Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
Aldara for the Treatment of Large and/or Multiple sBCC

BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.


Eligibility Criteria:
Inclusion Criteria:

* One or more sBCC on torso, neck or face
* Total surface area \<= 40 sq cm

Exclusion Criteria:

* Pregnancy or women who are breastfeeding
* Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors
* Metatypical, adnexal, or sclerodermiform carcinomas
* Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion
* Known HIV positive serology
* Skin tumor that is already or highly likely to become metastatic
* Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous)
* Previous organ transplant history
Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities

This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.

PRIMARY OBJECTIVES:

I. Determine the effectiveness of a core component of an integrated cervical cancer prevention program designed to help female smokers quit by standardizing clinical practice supports and protocols. (Service outcomes) II. Determine satisfaction with the multilevel intervention. (Client outcomes) III. Test the sustainability of the multilevel intervention via training of providers and staff on counseling and billing for evidence-based smoking cessation services. (Implementation outcomes)

OUTLINE:

IMPLEMENTATION OF TOBACCO-USER IDENTIFICATION SYSTEM: Clinics and systems develop and implement minimally required electronic tracking and reporting systems for identification of smokers during months 1-12.

GROUP RANDOMIZED TRIAL: Providers and participants are randomized to 1 of 2 arms.

ARM I (EARLY ARM): Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 13-24. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.

ARM II (DELAYED ARM): Female smokers receive usual care during months 13-24. Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 25-36. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.

Eligibility Criteria:
Inclusion Criteria:

* HEALTH SYSTEM/CLINIC
* Based in one of the Appalachian regions included in this program project
* Provides care to female smokers
* PROVIDER
* Practicing in one of the participating health systems
* Involved in patient care
* PATIENT
* Females
* Age 18 to 64
* Smokers who consume at least 5 cigarettes per day (less than the minimum in most cessation studies, yet still enough to show signs of nicotine dependence)
* Ready to quit smoking in the next 6 months
* English-speaking
* Able to participate in counseling
* Willing to try smoking cessation pharmacotherapy
* Not pregnant
Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients

Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas de Porto Alegre from october 2011 until november 2015 .

Objective: To compare the effectiveness of techniques: vibrocompression (G1), hyperinflation with mechanical ventilation (G2) vibrocompression + hyperinflation with mechanical ventilation (G3) in the amount of aspirated secretions, mechanical ventilator time, incidence of ventilator-associated pneumonia , reintubation tracheal and mortality in mechanical ventilator. Primary outcome: weight in grams of the aspirated secretions. Secondary outcome: hemodynamic and pulmonary parameters: heart rate, respiratory rate, mean arterial pressure, peripheral arterial oxygen saturation; peak inspiratory pressure, tidal volume; dynamic compliance ; mechanical ventilator time; reintubation tracheal; Incidence of ventilator-associated pneumonia and mortality in mechanical ventilator.

Eligibility Criteria:
Inclusion Criteria:

* In mechanical ventilation for a period of 24-72 h
* End-expiratory pressure (PEEP) lower 10 cm of water.
* Lower noradrenaline doses of 0.5mg / kg / minute for an average greater than or equal blood outstrips 60 mmHg.

Exclusion Criteria:

* Pneumothorax and hemothorax undrained
* Subcutaneous emphysema
* Osteoporosis
* Acute respiratory distress syndrome - (ARDS)
* Fractures of ribs
* Obese ( BMI greater than 35)
* Mechanical ventilator with higher peak pressures 40 cm of water.
BAX 855 Dose-Escalation Safety Study

The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male and is 18 to 65 years of age at the time of screening
* The subject has severe hemophilia A (factor VIII level \< 1%)
* The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)

Exclusion Criteria:

* The subject has a detectable FVIII inhibitor at screening, with a titer \>= 0.6 BU
* The subject has a documented history of FVIII inhibitors with a titer \>= 0.4 BU at any time prior to screening
* The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)
Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial

Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the environment contra lateral to a cerebral lesion, can be a major source of functional handicap after stroke. The currently available treatments for unilateral neglect are scanning training, visual cuing approaches, limb activation strategies, visual imagery, tactile stimulation, prisms and sustained attention training.Mirror therapy improves the hand function in sub-acute stroke.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.

About 30 - 50% of stroke patients are left with considerable residual deficits. The post stroke disabilities are due to loss of locomotion and activities of daily living, cognition and communication skills.Hemispatial neglect has been reported in association with damage to several different cerebral structures in a large-scale distributed neurocognitive network.Mirror therapy improves the hand function in sub-acute stroke. It also helps in the recovery of neglect in stroke patients. But little consensus exists as to whether one treatment is more efficacious than others and many studies fail to document duration of treatment effects or generalization to daily activities. The aim of our study is to evaluate the effectiveness of limb activation with MT and limb activation strategy alone in the management of stroke patients with unilateral neglect and to make the patient functional in activities of daily living.

Eligibility Criteria:
Inclusion Criteria: 1.All stroke patients with parietal lobe and thalamic lesions 2. Stroke duration: within 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan showing parietal lobe and thalamic lesion 5. Patients with upper limb weakness

Exclusion Criteria:

1. Stroke duration more than 1 yr
2. Glasgow Coma Scale (GCS) of less than 7
3. Uncooperative patients
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients

The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

In this cohort study, the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg negative chronic hepatitis B patients

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients

A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has been estimated at 40-70%. Those who have been suffered from limping for a long time may lead to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb triple view of x-ray is considered to be the current technique for determining LLD, it is costly and time consuming that not every hospital can afford it, and in case of radiograph, the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical assessment method by gathering exterior parameters to build up a Regression model for measuring the discrepancy and determining LLD accurately.

While using shoe lifts to correct discrepancy is the easiest conservative intervention for LLD, there are still many controversies on how much height should be added clinically and academically. The optimal height should be added depends on feedbacks from users and gait performance. The best gait performance can be measured from kinematic performance of center mass of body during walking. Therefore, this project wants to compare treatment responses between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in shoe lift height correction through triple view of x-ray and given optimal shoe lift height correction through analyzing kinematic performance of center mass of body.


Eligibility Criteria:
Inclusion Criteria:

* aged 20 to 70
* being able to walk independently
* being diagnosed with congenital SLLD or not
* willing to cooperate to wear shoe lifts
* has smart phone and willing to record information that investigators need
* willing to sign agreement

Exclusion Criteria:

* neurological diseases (i.e. Parkinson's disease, CVA, Polio, and lower limb nerve injuries, etc.)
* diabetes along with peripheral neuropathy
* history of lower limb fracture injury or joint replacement leading to uneven leg length
* osteoporosis along with compression fracture
* foot, ankle, or knee joint deformity, osteoarthritis or soft tissue pain that disturb gait performance (ex. degenerative osteoarthritis, plantar fasciitis, and etc.)
* pregnancy
* idiopathic scoliosis
* history of psychological disease or drug addiction
Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY

ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients hospitalized in ICU
* Patients under mechanical ventilation
* Patients with an expected length of stay of at least 4 days after inclusion
* Patients identified with an MDRB digestive carriage, determined by a positive rectal swab previously performed during ICU stay, according to usual screening
* Expected antibiotic (ATB) duration \< 10 days
* Informed written consent from the patient
* In unconscious patients who are not able to give consent for inclusion in the study, relatives (next-of-kin) give assent on every patient's behalf, and patients will be later given the opportunity to withdraw from the study

Exclusion Criteria:

* Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
* Antibiotherapy of more than 4 consecutive days at inclusion
* Confirmed or suspected intestinal ischemia
* Confirmed or suspected toxic megacolon or gastrointestinal perforation
* Any gastro-intestinal bleeding in the past 3 months
* Any history of abdominal surgery in the past 3 months
* Any history of chronic digestive disease or gastro-intestinal resection
* Any counter indication for Trendelenburg position
* Neutropenia (neutrophil counts \< 500 cells/µL)
* Ongoing immunosuppressive therapy (chemotherapy, any immunosuppressive agents, excluding corticosteroids \< 0,5 mg/kg/d of equivalent prednisolone)
* Enrollment in another trial that may interfere with this study
* Known allergy or intolerance to trehalose or maltodextrin and latex
* Pregnancy or breastfeeding
* Patients with EBV- serology
Quality of Life Following ECMO

The objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ECMO). The study population will include all adults treated with any configuration of ECMO at Duke University Medical Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality of life. In addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their ICU experience and answer specific questions regarding long-term comorbidities. Data will be stored in a secure online server which is HIPAA compliant and analyzed by the department of anesthesiology statistical support services. De-identified data will be shared with the WHO as specified in their usage agreement.


Eligibility Criteria:
Inclusion Criteria:

* VA or VV ECMO performed during retrospective study period

Exclusion Criteria:

* Pediatric
Amelogenesis Imperfecta

Amelogenesis Imperfecta (AI) are a heterogeneous group of rare genetic diseases transmitted according to various mode of inheritance (X-linked, autosomal dominant, autosomal recessive) affecting the formation/mineralization of tooth enamel. These diseases exist in isolation with clinical manifestations limited to the oral cavity or may be associated to other symptoms in syndromes. Many different genes (AMELX, ENAM, ENAMELYSIN or MMP20, KLK4, DLX3, FAM83H, FAM20A WDR72...) coding for enamel matrix proteins, enamel matrix degrading proteins, proteins involved in hydroxyapatite formation and growth and mineralization processes have been discovered responsible for the clinical phenotypes (hypoplastic, hypomineralized, hypomature) encountered in AI.

Genes involved in enamel formation but not yet identified in association with any form of AI include: AMELY, AMELOBLASTIN, TUFTELIN, AMELOTIN, A Pin protein, ODAM (Odontogenic ameloblast associated).

In this research protocol the investigators explore the phenotype including the enamel ultrastructure and the genotype of a cohort of patients presenting AI.


Eligibility Criteria:
Inclusion criteria:

* Patient presenting with AI
* New patient or patient already known in the center
* Child (in his primary dentition) or adult
* Man or woman
* Having signed a consent form or accepted to participate to the study
* Patient affiliated to social security
* Validation of the inclusion by the principal investigator looking at the patient file

Exclusion criteria:

* Patient with acquired enamel defects
* Patient whose clinical diagnostic is not possible
* Patient whose clinical file does not contain teeth photos
* Patient who has not signed a consent form and accepted to participate to the study
* Patient who is not affiliated to social security.
* Non validation of the inclusion by the principal investigator looking at the patient file
Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy

This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* -Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology.
* Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
* Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
* Patients must received treatment with a chemotherapy regimen .
* Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
* Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
* Expected survival of ≥ 3 months
* There is no maximum number of prior medical therapies.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin
* Pregnant women are excluded from this study.
* Life expectancy less than 6 months
* Inability or unwillingness to comply with research protocols.
* Patients with the presence of active brain or meningeal metastases.
* Patients with the presence of uncontrolled closed-angle glaucoma.
* Patients with the presence of neuropathy caused by any type of nerve compression as diabetes.
* The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements.
* The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) \> 450 ms (men); QTc \> 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
* Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,