cyrilzakka/clinical-trials huggingface dataset:
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥40 years
* Patients with stable COPD according to GOLD strategy (GOLD 2011).
* Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC ≥ grade 2

Exclusion Criteria:

* History of long QT syndrome or prolonged QTc
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
* Patients with Type I or uncontrolled Type II diabetes
* Patients with a history of asthma or have concomitant pulmonary disease
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
* Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
* Other protocol defined inclusion/exclusion criteria may apply
Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.

Early identification of individuals at high risk remains the cornerstone of primary cardiovascular prevention (CV). However, cardiovascular screening including people at low CV diseases (CVD) risk are too costly, time consuming and poorly effective in reducing incident CV events to be proposed at population level. Thus, innovative tools that allow to exclude low risk subjects in order to concentrate the relatively poor resources of NHS for primary prevention in high risk groups are needed. In this study, we will assess whether a new low cost strategy for CV risk stratification, based on non-laboratory measures, will allow to recognize low risk subjects who do not need further and expensive measures. To this end, we will take advantage of a General Practitioners (GPs) national network that will allow to work in the natural contest of primary prevention. If successful, the project will provide the basis for future, cost-effective prevention programs to be performed at national level.

National, multicenter cross-sectional study.

The current study will be performed as part of Italian Cardiology Network implemented by the Italian Ministry of Health.

This study will be carried out with the collaboration with Study Center for Primary Care.

A random sample of subjects identified by the list of patients in charge of the participating GPs aged 40-70 years will be invited to a screening for the evaluation of their CV risk.

All patients who agree to participate in the study and sign the consent will complete a health self-assessment questionnaire which includes questions covering anthropometric, sociodemographics, personal and family health history, life style habits and aspects of the behavioral domain.

This will be followed by biometric measurements including height, weight and waist circumference conducted at the consulting room of the GP by certified staff. Informative predictors, selected among all variables selected, will be identified by a stepwise multivariable logistic regression. The low risk CV score will be calculated as the sum of the coefficients of the retained variables.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 40-70 years

Exclusion Criteria:

* Patients with previous cardiovascular events
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control.

Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
2. Must be 18 years or older
3. Must speak English, Spanish, or Somali
4. Patients must receive steroids for fetal lung maturity as part of their hospital course

Exclusion Criteria:

1. Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
2. Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping

Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature \<34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<29 weeks' gestation born in the study centers

Exclusion Criteria:

* Congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team
Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5

This study is a proof-of-concept clinical study designed to test the hypothesis that oral administration of galactose can lower the level of a circulating factor that increases glomerular permeability to albumin in patients with resistant FSGS.

Patients with resistant FSGS have persistent proteinuria and a high risk of progression to end stage kidney disease (ESKD). A circulating factor that increases glomerular permeability to albumin (Palb) has been detected in over 50% of these patients. While the molecular identity of the factor has not been fully established, in vitro studies and limited clinical experience suggest that galactose can reduce the level of the FSGS permeability factor.

This study is a pilot study to determine if oral administration of galactose can lower the circulating level of the FSGS permeability factor.

Five patients with biopsy proven primary FSGS - native or transplant kidney, receiving plasmapheresis - who are resistant to steroids and one other immunosuppressive agents will be studied.

The only eligibility factor is presence of the FSGS permeability factor.

The experimental intervention is administration of galactose, orally, 0.2 g/kg body weight/dose twice daily. the duration of treatment will be 28 days,.

Patients will be seen on days 0, 14, and 28 of treatment. They will be seen at week 8, 16 and 24 after discontinuation of the galactose.

Physical examination and routine laboratory tests (SMAC, CBC, urine protein:creatinine ratio in an early morning sample) will be done at each visit. The FSGS permeability factor will be assayed at days 0 and 28 of treatment and 6 months after discontinuation of the galactose. The permeability factor will be tested in the laboratory of Virginia Savin MD (Medical college of Wisconsin) using previously described methods.

All other treatments will be unchanged during the 28 day oral galactose Treatment Period.

The study will be analyzed based on the number of patients in whom the FSGS permeability factor is lowered to normal levels.

Eligibility Criteria:
Inclusion Criteria:

* Primary FSGS
* CKD Stage 5
* Resistance to steroids and another immunosuppressive medication

Exclusion Criteria:

* Secondary FSGS
Manual Wheelchair Propulsion Training

The purpose of this research study is to investigate a manual wheelchair training program to improve the way manual wheelchair users push their wheelchairs.

The purpose of this research is to create a manual wheelchair propulsion-training program (MWPTP) that emphasizes propulsion techniques that improve the manual wheelchair users stroke pattern and efficiency. It is our hope that the design of a manual wheelchair-training program can help to minimize the upper extremity pain and injury often associated with manual wheelchair propulsion.

The MWPTP will exist in three forms, and will be given to three randomly assigned groups of subjects. An instruction only group (IO) will receive general instructions on how to best propel their wheelchair. A feedback group (FB) will receive additional instruction in wheelchair propulsion using a monitor displaying a random combination and amount of biomechanical feedback variables, such as cadence and proportion of time spent in propulsion. Subjects will be coached to develop an appropriate propulsion style that minimizes all of the predetermined feedback measures, which indicate poor technique and maximize all of the graphical measures indicating good propulsion technique. A control group (CG) will receive only testing which will be identical to the testing procedures followed by the IO and FB groups.

Participation in this study will consist of four visits to the Human Engineering Research Lab (HERL) for the FB, IO and CG. Visits 1-4 will be the same, except visit 4 will not include training for any of the groups. All subjects will use their own wheelchair and cushion; however researchers will attach SMART Wheels TM to the subjects' wheelchair in place of their current wheels. The SMART Wheels TM are used to record the forces and moments that occur during propulsion and will not alter the dimensions or feel of the subjects current wheelchair. During each visit, all subjects will be asked to push over a real life course that includes various grades and surfaces. Then they will be asked to push on a wheelchair dynamometer at 1 meter/sec for one minute, 2 meter/sec for one minute, and a self selected speed for one minute. During this time, data will may also be collected with use of an Optotrak kinematic measurement system that incorporates a camera 3D-motion analysis system.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Use of a manual wheelchair as primary means of mobility (\>80% of their ambulation)
* Spinal Cord Injury (SCI) cervical 7 level and lower

Exclusion Criteria:

* Wheelchair athletes having competed in racing in the last year.
* Current upper limb pain that limits mobility.
* \<1 year post inpatient rehabilitation
Exercise Response in Humans With Obesity

This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.


Eligibility Criteria:
Inclusion Criteria:

* Obese men and women ≥ 20 and ≤ 45 years of age.

Exclusion Criteria:

* Diabetes or fasting plasma glucose \>126 mg/dL
* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease defined as aspartate aminotransferase (AST)\>144 IU/L or alanine transaminase (ALT) \>165 IU/L)
* Oral warfarin group medications or history of blood clotting disorders.
* Smoking
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled hypothyroidism
* Debilitating chronic disease (at the discretion of the investigators)
Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder

Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes

Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients

Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals

Treatment - Fesoterodine (Toviaz) 4 or 8mg

Interventions (2 arms)

- Arm 1: No intervention

Patients in this arm will not be given HEI in conjunction with pharmacotherapy (Toviaz) which was developed for this trial.

- Arm 2: Health education intervention (HEI)

HEI will be performed by trained study coordinators with the leaflet designed for this trial composed of 4 parts.

1. Part 1: Understanding OAB Physiology of bladder Definition, symptom and prevalence of OAB OAB in a treatable condition. There are many options that may help your symptoms. Lifestyle change Medications Bladder training Pelvic floor muscle exercise
2. Part 2: Behavioral/lifestyle modification Modification of dietary habits Limit bladder irritants- caffeine (coffee, tea, coke...), juice, chemical flavors, spicy food. etc. Altering fluid intake Weight management Learn how weight can affect their condition Stop smoking Constipation management
3. Part 3: Bladder training Timed voiding- Goal is urinating every 3 or 4 hours during the day without fear of wetting accidents.

   Urgency suppression Pelvic muscle contraction, count backwards from 100 by 7seconds, etc Pelvic floor muscle exercise Contraction (fast and slow) and relax the muscle for a count of 3. Repeat the fast and slow contractions 10 - 15 times. Do those at least 3 times a day.
4. Part 4: Understanding antimuscarinics How the medicine works How to take it Tips that may help manage side effects- dry mouth, constipation Therapy expectations
5. HEI include 3-day voiding diary for self tracking method.

Eligibility Criteria:
Inclusion Criteria:

* Female aged ≥ 18 years with OAB symptoms for ≥ 3 months
* The sum score of the OABSS ≥ 3 with the score of the question no.3 (urgency) ≥ 2
* The sum score of the OAB V8 ≥ 8

Exclusion Criteria:

* Any condition that would contraindication of anticholinergic treatment
* Symptomatic acute UTI during the run-in period
* Diagnosed or suspected interstitial cystitis
* Treatment with anticholinergic drugs within 12 months prior to Screening and persist over 3 months
* Treatment within the 14 days preceding Screening, or expected to initiate treatment during the study with any other treatment for overactive bladder.
* An indwelling catheter or practicing intermittent self-catheterization
* Pregnant or nursing women
Impact of Forearm Free Flap in Orbital Exenteration Reconstruction

Orbital exenteration is the en bloc removal of the entire orbital contents. This mutilating surgical technique is reserved for the management of certain malignant orbito-palpebral tumors or those that secondarily invade the orbit.

Several types of exenteration have been described, more or less extended to the adjacent structures, with sometimes mixed ENT-neurosurgical approaches for lesions invading the endocranium and causing large losses of substance.

Different surgical reconstruction techniques have been developed over the years, from spontaneous epithelialization to free osteo-muscular flap and temporal muscle transpositions.

Reconstruction after exenteration is essential to limit the sequelae and to allow the patient who has undergone this trauma to regain social interactions, a quality of life and an optimal self-image.

The use of an antebrachial free flap would allow a faster healing and thus an earlier rehabilitation.

The main objective of the study was to compare the morbidity of the antebrachial free flap with that of the temporal flap during exenteration and the rate of fitting of patients with epitheses.

Reconstruction after exenteration is essential to limit the after-effects and to allow the patient who has suffered this trauma to regain social interaction, quality of life and self-image.

The principal investigator hypothesize that reconstruction with a free antebrachial flap can improve the quality of life of an exentered patient while maintaining a low risk of intra- and post-operative morbidity.

The aim of such a study will therefore be to provide assistance to both surgeons and patients, as to the choice of the technique of orbital reconstruction, by highlighting objectively and subjective evidence of the benefits of one technique over the other.

The patients included in this study will have to answer two questionnaires, submitted by post or directly at the follow-up consultation. This study therefore falls within the framework of studies of minimal or moderate risk studies. They will be informed by telephone interview beforehand or directly in the consultation about the method of writing the questionnaires and their content.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were exentered and then reconstructed by free antebrachial flap or temporal muscle flap muscle flap at the Institut Curie Paris, between January 2005 and December 2020.

Exclusion Criteria:

* Legally protected patients
* Patients unable to give consent.
PFDD Versus PFDRT in Chiari Decompression Surgery

The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥14 years old
* Chiari malformation type I ≥5 mm tonsillar ectopia
* a syrinx with a width \> 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments.
* MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center

Exclusion Criteria:

* included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess;
* other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., Klippel-Feil, atlas assimilation, etc.);
* degenerative or demyelinating disease;
* CM-I without syringomyelia;
* syringomyelia with cerebellar tonsils in a normal position;
* fibromyalgia;
* chronic fatigue syndrome;
* prior posterior fossa surgery.
* Unable to share pre-decompression MRI of the brain and spine Patients who do not wish to participate
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

* Clinically significant Medical History
* In the case of women, pregnant(Urine-HCG positive) or lactating women
Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis

The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis.

It is carried out on cosmetic products, with the aim to further confirm safety of these products

Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics.

Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification.

Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.

Eligibility Criteria:
Inclusion Criteria:

* Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids
* Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index \>25)
* Participant presenting with a current lesion of Atopic Dermatitis on defined area

Exclusion Criteria:

* Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study
* Participant having background of intolerance or allergy
* Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects
* Participant having skin exposed to sunlight within 2 weeks preceding the inclusion
* Participant having modified his/her cosmetic habits during the last two weeks