cyrilzakka/clinical-trials huggingface dataset:
ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.

Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent

Exclusion Criteria:

* Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).

Known kidney insufficiency: GFR \<30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder

The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 to 60 years of age (inclusive)
* Outpatients with a current diagnosis of OCD that have received previous therapy
* Negative serum pregnancy test as screening in women of child-bearing potential
* If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception
* No clinically significant abnormality on electrocardiogram (ECG)
* No clinically significant laboratory abnormality at screening
* Negative urine drug screen
* Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule

Exclusion Criteria:

* Diagnosis of substance dependence
* Diagnosis of substance abuse (except for nicotine and caffeine)
* Serious or unstable medical illnesses
* Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder
* Diagnosis of tic disorder or Tourette's Syndrome
* Subjects diagnosed with impulse control disorder
* Known sensitivity or allergic reaction to either naltrexone or fluoxetine
* Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study
* Immediate family of investigators, study personnel or Sponsor representatives
On Top of Everything

Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health at six-month follow-up.

Our secondary aim is to evaluate the effectiveness of the teacher training programme to teach mindfulness in a vulnerable subgroup of students on their self-reported mental health at three and six months after baseline.

The study is designed as a pragmatic cluster randomised two-arm trial including 43 Danish schools (30 upper secondary schools and 13 schools of health and social care). The schools included a total of 76 school teachers for teacher training (44 teachers from upper secondary schools and 32 teachers from schools of health and social care). Each included teacher will be asked to recruit a class of students (15-30 students) to test the effectiveness of the modified MBSR programme (in total approx. 1.000 students).

Eligibility Criteria:
Inclusion Criteria:

* All students in the enrolled school classes

Exclusion Criteria:

* None
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

The objectives of this Phase I/II study are:

1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy receiving chemotherapy and to define a "Study Dose" for Phase II.
2. To evaluate the hematopoietic and immunological responses after administering of PG2. Primarily to study the biological response of PG2, defined as WBC count in this study, and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.

This study is the first step for PG2 clinical development in Taiwan in order to further establish its safety and efficacy profile and to build the basis for larger trials.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have malignancy with metastatic or recurrent diseases.
* Patient must have a minimum of thirteen days period elapsed from any previous chemotherapy or radiotherapy and all treatment-related toxicities subsided.
* Patient must have at least 2 courses of chemotherapy treatment left, and a minimum of 13 days between the administration of the last dose of the chemotherapy with PG2 and the start of the next course of chemotherapy.
* Performance status is 0-2 by ECOG scale.
* Patient's compliance and geographic proximity that allow adequate follow up.
* Adequate bone marrow function before the chemotherapy
* Adequate liver and renal function before the chemotherapy
* Written informed consent from patients
* Woman with childbearing potential should use contraception method through the whole PG2 treatment course.
* After the previous course of chemotherapy, the nadir of WBC dropped between 1000 to 3000/ mm3 (for phase II only).

Exclusion Criteria:

* PG2 skin test is positive.
* Active infection
* Breast feeding
* Prior radiotherapy more than 30% of the bone marrow involved.
* Pregnant woman
* Bone marrow transplantation or brain disease
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.

Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock. This post-CA shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. Experimental data suggest that intravenous ascorbic acid (vitamin C) may attenuate inflammation and vascular injury related to sepsis or surgery. Preclinical and clinical studies also provide safety data of high dose intravenous vitamin C (\> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. Experimental data also suggest beneficial effect of vitamin C in post-CA management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome.

The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups :

* Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days.
* Control group: Standard of care care for post CA shock according international guidelines.

Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days


Eligibility Criteria:
Inclusion Criteria:

* patients still comatose (Glasgow coma scale \< 8) after an OHCA of presumed cardiac origin with ROSC \< 60 min;
* and treated with a norepinephrin or an epinephrin continuous infusion during at least 30 min before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.

Exclusion Criteria:

* patients still comatose (Glasgow coma scale \< 8) after an OHCA of presumed cardiac origin with ROSC \< 60 min;
* and treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) ≥ 65 mmHg.

Exclusion criteria:

* minor or pregnant women;
* OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.);
* interval between RACS and randomization \> 6 hours;
* extracorporeal circulatory assistance requirement in the first 4 hours after OHCA;
* history of urolithiasis, oxalate nephropathy or hemochromatosis;
* glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie
* patients already treated with vit-C; known vit-C deficit;
* inclusion in another study;
* pre-existent severe chronic kidney disease (glomerular filtration rate \< 30ml/min);
* treatment limitationsor moribound
* Patient with derpived freedom or with legal protective measures.
* Patient not covered by French national health insurance
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length

CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.


Eligibility Criteria:
Inclusion Criteria:

* CavatermTM operation because of menorrhagia
* timeframe: January 2006 till August 2009
* older than 29 years and younger than 56 years

Exclusion Criteria:

* pregnancy
* fragmentary filled questionnaire
* more than 1 CavatermTM operation
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Objectives:

1. To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases
2. To determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo.

Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects with proteinuric renal disease (\>400 mg/24 hours)

Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months

Eligibility Criteria:
Inclusion Criteria:

1. Stable chronic kidney disease
2. Urine protein : Creatinine ratio \> 0.4
3. Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min
4. PTH (intact) \>20 pg/ml and \<250 pg/ml
5. Age 18-85
6. If on ACEI/ARB, then dose optimized (BP, K)

Exclusion Criteria:

1. Failure to provide informed consent
2. Glomerunephritis requiring active treatment with immunosuppresive therapy
3. Serum phosphorus \> 5.2
4. Serum calcium (adjusted for albumin)\> 10.0
5. Active malignancy
6. Likelihood of requiring renal replacement therapy within 1 year
7. Uncontrolled hypertension
Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites

Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.


Eligibility Criteria:
Inclusion Criteria:

* Presence of papules resulting from insect bites within the last 72 hours;
* Presence of symmetric lesions to compare one side to the other;
* Compliance of the subject to the treatment protocol;
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old.

Exclusion Criteria:

* Pregnancy or risk of pregnancy;
* Lactation;
* Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study;
* History of atopy or allergic diseases;
* History of allergy of any component of the formulations;
* Other conditions considered by the investigator as reasonable for non-eligibility.
Performance and Adherence in Children Using Spacers

Asthma is a common disease which causes swelling in the airways, making it difficult to breathe. Asthma is common in children, affecting 1 in 11 children in the UK. Asthma is treated with inhalers which reduce the swelling. If inhalers are taken correctly they can help keep symptoms under control, allowing asthma sufferers to go about their day with less chance of having an asthma attack. Many patients have been found to not take their inhalers correctly and either under use (which leads to poor control of symptoms) or over use (which leads to potential side effects).

Although asthma in most patients can be controlled with inhalers, not using inhalers correctly is one of the most common causes of poor control. This is common in children and young people (CYP) with all severities of asthma, resulting in high burden on the families and healthcare systems.

The biggest challenge facing doctors and nurses helping CYP with asthma is finding a way to ensure that they take the medication. Whilst there are many studies looking into inhaler use, there are no large studies about how inhalers are used between clinic visits in CYP with asthma.

The Smart Spacer is monitoring device which allows doctors to monitor when and how effectively inhalers are being used. This study wants to find out how well this device works, how well and how often CYP are using their inhalers, and if tailored education improves asthma control. To do this, participants in the study will be randomly selected to have "tailored education" or "standard care education".

The investigators are inviting 100 children and young people (CYP) aged 6-18 years who have asthma to join this study.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6-18 years;
* Attending secondary care with a diagnosis of asthma;
* Willing and able to give fully informed consent, or, participants having an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 16 years of age);
* Able to perform lung function and exhaled nitric oxide measurements;
* Take twice-daily preventer medication using a valved holding chamber (spacer device) i.e. inhaled corticosteroid with or without long-acting beta antagonist;
* Willing and able to comply with the study procedures.

Exclusion Criteria:

* Significant co-existing respiratory disease (e.g. cystic fibrosis);
* Currently participating in another clinical trial of an investigational medicinal product or medical device;
* Non-English speaker where translation facilities are insufficient to guarantee informed consent.
Alexander Technique Neck Pain

This study aimed to test the efficacy of five Alexander Technique lessons compared to the same period of heat pad application and guided imagery in patients with chronic non-specific neck pain.

see above

Eligibility Criteria:
Inclusion Criteria:

* chronic non-specific neck pain
* at least 3 months
* 40mm pain intensity on visual analog scale

Exclusion Criteria:

* neck pain as consequence of disc protrusion or prolapse, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, neurological disorder,
* active oncologic disease
* affective disorder
* addiction
* psychosis.
* pregnancy
* invasive treatment of the spine within the previous three weeks
* spinal surgery
* previous experiences in Alexander Technique
* ongoing application for disability pension
* simultaneous participation in other clinical trials on neck pain
Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia

A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking caregiver-child dyads
* Children must be between ages of 5-18
* Child must be overweight or obese (defined as a BMI greater than the 85th percentile for their age and sex)
* Child must have been diagnosed with ALL
* Child must have completed their final cancer treatment and currently be in remission
* Only children and adolescents who have not yet graduated from high school and are living at home with their caregiver at least 50% of the time will be invited to enroll
* Participating caregivers and children must be able to perform some level of exercise

Exclusion Criteria:

* Children who are wards of the state
* Caregivers and/or children who are taking a weight altering medication without being at current dosage for at least six months and weight stable for at least three months
* Caregivers and/or children who are actively involved in another intensive weight loss program
* Caregivers and/or children who have undergone weight loss surgery within the last two years and/or who are still losing weight
* Caregivers and/or children with certain diagnosed psychiatric conditions (e.g., history of/active eating disorder, developmental delays/intellectual disabilities such as Down's syndrome and severe presentations of autism spectrum disorder, active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, severe substance use disorder) that would interfere with their ability to participate
* Caregivers and/or children with certain chronic medical conditions (e.g., type 1 diabetes, muscular dystrophy) for whom participation may be contraindicated
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.

The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.

Adherence will be measured by MEMs cap.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
* Subjects must have \>5% TBSA and \<30% to be enrolled.
* Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Exclusion Criteria:

* Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
* Requiring \>130 gm of cream in a 2 week period.
* Having facial or groin involvement of their disease.
* Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Risperidone in low doses is compared with placebo in a 6-week randomized trial. Subjects also receive supportive counseling. Outcome measure include rating of behavior, mood, drug abuse, global function, and urine toxicology.

Eligibility Criteria:
Inclusion Criteria:

Cocaine abuse or dependence

Exclusion Criteria:

Dependence on other drugs. Major psychiatric illness
Workplace-Sponsored Program to Reduce Obesity

The purpose of this study is to design a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Health lifestyle promotion interventions addressing portion control, healthy nutrition, and increasing physical activity will be tested.

BACKGROUND:

Broad, population-based approaches are needed to stop or reverse the rise in obesity prevalence. According to the World Health Organization, obesity prevention can be achieved by promoting a healthy diet and a physically active lifestyle. A partnership with the Eastman Kodak Company has been developed to test a worksite intervention for obesity prevention in Rochester, New York.

DESIGN NARRATIVE:

The overall goal of this study is to design a comprehensive nutrition and physical activity strategy based on participatory research to promote a healthy lifestyle and to stop the shift of the population body mass index (BMI) curve to the right. Six pairs of worksites will be randomized to either an intervention or control group. Two cross-sectional samples of employees within each worksite will be measured at baseline and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Full-time employees in good health