cyrilzakka/clinical-trials huggingface dataset:
Optimal Bowel Cleansing Trial

Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.

The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.

Eligibility Criteria:
Inclusion Criteria:

* Pts for out-patient colonoscopy
* age 18-80

Exclusion Criteria:

* Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
* Suspicion of renal insufficiency or ileus/subileus
* Previous colonic surgery
* Pregnancy
* Inability to adhere to cleansing instructions
* Inability to consent
Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions

Non-carious cervical lesion is frequently associated with gingival recession, resulting in a combined lesion that has a different treatment prognosis when the two lesions appear alone. The literature presents few studies that propose a multidisciplinary approach (restorative and root coverage surgery procedures) to optimize the treatment of this combined lesion. The previously proposed approaches and materials have limitations and an optimal clinical protocol has not been established yet. Thus the aim of this study is to evaluate a novel multidisciplinary protocol with two resin composites and two different adhesive systems through a randomized clinical trial and laboratory studies. 120 combined lesions will be randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of cervical lesions with nanofilled composite and total-etch adhesive system and periodontal surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with nanofilled composite and self-etching adhesive system and periodontal surgery for root coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA (n = 30) - partial restoration of cervical lesions with microhybrid composite and self-etching adhesive system and periodontal surgery for root coverage. Restorations will be assessed using the USPHS criteria after one week, six months and twelve months.


Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting one or more combined defect, i.e. a NCCL classified as B+ (Pini-Prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with Miller's class I or II gingival recession in canines or premolars with pulp vitality;
* Healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion;
* Plaque index ≤ 20% (Ainamo \& Bay, 1975);
* NCCL cavo-surface margin without involvement of more than 50% of enamel;
* In tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; Provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (Resolution #196 October 1996 and the Code of Dental Professional Ethics - C.F.O. - 179/93).

Exclusion Criteria:

* NCCL previously restored;
* Presence of caries;
* Patients with periodontitis;
* Patients with bruxism or teeth clenching;
* Patients with orthodontic treatment in progress;
* Pregnant patients or smokers;
* Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, diabetes and others), which contraindicate the surgical procedure; Previous periodontal surgery in the area of interest of the present study.
Cerebral Oximetry and Anesthetic Technique

The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.

Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo elective total hip arthroplasty
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* Pulmonary disease
* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Neurologic disease
* Coagulation disorders
Understanding the Effect of Metformin on Corus CAD (or ASGES)

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.

Eligibility Criteria:
Inclusion Criteria:

At least 21 years of age

Any of the following:

* Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
* Low-risk unstable angina, or
* Asymptomatic individuals with a high probability of CAD

Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:

* HgA1C: \>5.7% - \<6.4%,
* BMI\> 35 kg/m2
* Age\< 60 yrs
* Prior Gestational Diabetes Mellitus
* FPG: \>100mg/dl - \<126mg/dl
* OGTT: \>140mg/dl - \<200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent

Exclusion Criteria:

* History of or current level of HbA1C \>6.5
* History of or current prescription of metformin or any other diabetic medication
* History of myocardial infarction (MI) or prior revascularization
* Current MI or acute coronary syndrome (ACS)
* Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
* Current systemic infectious or systemic inflammatory conditions
* Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents
Gastric Ultrasound

The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.

Exclusion Criteria:

* History of upper gastro-intestinal surgery.
MSFC Versus DAM. A Smartphone Application for Multiple Sclerosis Self-assessment.

Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation is not always optimal as it can prove to be very time consuming. Moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status.

A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was developed in order to replicate each of MSFC tests available in order to assess MS progression in the patient environment.

Patients are selected during a consultation at the Neurology department of the Pitié-Salpêtrière Hospital (France). Each patient is given access to DAM on their own or a provided iPhone. During the enrolment visit, patients have to complete a MSFC and DAM evaluation (V0). Through a push-notification on their phone, patients are reminded to perform two DAM evaluations at home at days 30 (V1) and 60 (V2). At day 90 (V3), they have to come back to hospital for a second MSFC and DAM evaluation

Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of Multiple sclerosis according to the MacDonald criterias whatever the progression stage, that are monitored by Dr. Maillart as part of her consultation at the Neurology department of the Pitié-Salpêtrière Hospital.
* Patients with an iPhone (at iOS 8 or higher).
* Patients age ≥18 years.
* Patients with an initial score of EDSS between 0 to 6.5
* No attack since at least 1 month
* Last Solumedrol injection at least 1 month ago

Exclusion Criteria:

* Patients who are not capable of using a smartphone application.
* Patients who do not have the capacity to give their consent.
* Patients who do not speak French
* Patients who are bedridden or with a daily activity of less than 2 hours per day
* Patients with acute asthenia
* Patients experiencing an attack once enrolled in the study (will be considered as dropouts)
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A or B
* Bodyweight max 100 kg
* Body Mass Index (BMI) max 30 kg/m2
* Adequate venous access

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
* The receipt of any investigational product within 30 days prior to enrolment in this trial
* Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
* The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
* Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
* Known pseudo tumours
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any major and/or orthopaedic surgery within one month prior to trial start
* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
* Clinical signs of renal dysfunction
* Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
* Use of non-prescribed opiate substances
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with previously untreated advanced stage, CD20-positive FL
* Patient with ECOG performance status 0, 1 or 2.

Exclusion Criteria:

* Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
* Patient who has previously received any prior therapy for lymphoma
* Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
* Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
* Pre-operative regular corneal astigmatism of \>= 0.75 diopters and \<= 2.0 diopters
* Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
* Projected best spectacle corrected visual acuity of 20/20 or better
* Clear intraocular media other than cataract
* Potentially good vision in fellow eye
* Fully dilated pupil of \>= 7.0 mm

Exclusion Criteria:

* Zonular laxity or dehiscence
* Pseudoexfoliation
* Age related macular degeneration
* Retinal degenerative disorder
* Diabetes with any evidence of retinopathy
* Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
* Corneal dystrophy, previous corneal or intraocular surgery
* Complications during cataract surgery
* Serious co-morbid conditions
* Systemic medications that my increase UV sensitivity
* Irregular astigmatism
Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult

The purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (CT) or magnetic resonance imaging (MRI) in those greater than or equal to 65 years of age (older adults) that are seen in the Emergency Department (ED).


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and older
* Patients in need of sedation prior to either a computerized tomography (CT) or magnetic resonance imaging (MRI)

Exclusion Criteria:

* Patients who weigh \< 50 kg
* Cardiac arrhythmias or QTc \>450
* Intravenous access not standard of care or unable to obtain
* Patients with any allergies or contraindications to dexmedetomidine, haloperidol (i.e. patients diagnosed with Parkinson's) or lorazepam
* Patients with low blood pressure, defined as a less than 100/60 mmHg
* Patients with bradycardia (Heart rate \< 60 bpm)
* Patients presenting with chief complaint of respiratory distress/failure
* Intranasal administration contradictions: nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal damage, recent use of nasally administered vasoconstrictors such as cocaine, oxymetazoline, and phenylephrine
A Drug Interaction Study of Simvastatin and Albiglutide

This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Eligibility Criteria:
Inclusion Criteria:

* no clinically significant diseases or clinically significant abnormal laboratory values
* females must be of non-childbearing potential
* body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
* nonsmoker
* negative drug screen

Exclusion Criteria:

* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* any clinically relevant abnormality
* female subject is pregnant or breast-feeding
* history of any anaphylactic reaction to any drug
* history of significant cardiovascular or pulmonary dysfunction
* current or chronic history of liver disease
* history of alcohol or substance abuse
* history of thyroid dysfunction or disease
* history of gastrointestinal surgery or disease
* history of pancreatitis
* previously received any GLP-1 mimetic compound (e.g., exenatide)
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia

This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- \<19 years) with newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).

An advanced practice nurse (APN) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy. The physical therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention. The PT will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135. During weeks 9-135 of the intervention, the APN will call between the monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity to the intervention and to provide booster support to the intervention where needed.

Eligibility Criteria:
Inclusion Criteria:

1. An immunophenotypic diagnosis of non-B cell ALL
2. Age 4 years through \<19 years at diagnosis
3. 2-8 days on or per front line ALL treatment protocol
4. One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
5. Participant speaks and understands the English language
6. Written informed consent and child assent

Exclusion Criteria:

1. Age \< 4 years or ≥19 years at diagnosis
2. A diagnosis of cerebral palsy or down syndrome
3. Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
5. Females who are pregnant.
Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

The primary objective of this study is to determine if well-controlled asthmatic patients followed in subspecialty asthma clinics between the ages of 3 - 18 years can be distinguished from healthy controls using lung clearance index, a parameter from the multiple breath washout test. Also, to correlate lung clearance index with asthma sputum cell counts.

Clinical studies are underway which are examining the utility of the LCI in obstructive respiratory disease (cystic fibrosis and asthma). However, the majority of studies have examined asthmatics with ongoing evidence of reversible disease on spirometry. There is a very limited body of research comparing LCI values in well-controlled asthmatics to healthy controls. Furthermore, the type of inflammation occurring in asthma may have a different site of action, we will prospectively study whether there is a difference in LCI between eosinophilic and neutrophilic inflammation to give us an indication of whether the site of non-eosinophilic inflammation is primarily in the small airways as well.

Eligibility Criteria:
Inclusion Criteria:

* Asthma Subjects:

  * 3 - 18 years of age at enrolment
  * Clinically stable at enrolment
  * Physician diagnosis of asthma and attending follow-up in the Asthma Clinic

Exclusion Criteria:

* Asthma Subjects:

  * Born premature (before 37 weeks gestational age)
  * Low birth weight (less than 2.5 kilograms)
  * History of congenital heart disease, neuromuscular disorder or bone disease
  * History of any chronic lung disease other than asthma
  * Respiratory infection in last three weeks
  * Change in medication in last three weeks (including oral steroids)
  * Current or previous history of smoking
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)

The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
* Participant who has low bone mineral density
* Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
* Participant is ambulatory (can walk)

Exclusion Criteria:

* Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
* Participant has received osteoporosis medications or other medications that affect bone
* Participant is already participating in another drug study