cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the Ethmoid Sinus Spacer

Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years old
2. Both male and female
3. Ethmoid disease on CT scan
4. At least one non-ethmoid sinus requiring treatment
5. Failed medical management and symptomatic

Exclusion Criteria:

1. Previous ethmoid surgery
2. Not sufficient room for placement of Spacer
3. Patient requires septoplasty
4. Has received steroid treatment with in 2 weeks
5. Extensive sinonasal osteoneogenesis preventing device placement
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy
8. Asthmatic patients with aspirin sensitivity
9. Pregnant or lactating females
DESolve® X-Pand Global Post Market Registry

The X-Pand Registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with DESolve in patients with CAD.

The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.

The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \& internal hospital guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Minimal age 18 years
2. Patient is willing/able to cooperate with study procedures and required follow up visits. Patient or legal representative has been informed \& agrees by signing EC approved written consent. Consent can occur before implantation of the DESolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure).
3. Planned or unplanned DESolve scaffold implantation

Exclusion Criteria:

None
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood

Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.

The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 55 years old
* Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
* Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
* If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.

Exclusion Criteria:

* Opiate maintenance (e.g., methadone or buprenorphine)
* Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
* Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
* Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
* Physical health problems
* History of significant cardiac problems
* History of seizures
* Pregnancy
* Persons with a demand-type cardiac pacemaker
* Persons receiving vagus nerve simulation
* Persons receiving deep brain stimulation
* Participants cannot have any conditions that are contraindicated for MRI
Respiratory Muscle Dysfunction in Critically Ill Patients

Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.

The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis / septic shock
* Clinical reason for laparotomy
* \> 18 years

Exclusion Criteria:

* No informed consent
* Medical history of myopathy
* Unintended weight loss before ICU admission
* Pregnancy
* Chronic use of corticosteroids
PeRiopEratiVE SmokiNg CessaTion Trial

PREVENT is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. This trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. PREVENT will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.


Eligibility Criteria:
Inclusion Criteria:

1. are ≥18 years of age
2. are scheduled to undergo surgery within 28 days
3. are a current smoker and not currently using any smoking cessation treatment and,
4. have a smart mobile phone with an active, up to date data plan and with internet access
5. provide informed consent to participate.

Exclusion Criteria:

1. are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period
2. are deemed unreliable for study procedures or follow-up
3. have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo.
4. had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks.
5. will have surgery with expected nil intake by mouth for 2 or more days
6. have previously participated in PREVENT
7. have a known diagnosis of untreated pheochromocytoma; Schizophrenia/bipolar psychiatric illness and currently psychotic; currently having suicidal ideation or risk of suicide as determined by the site physician, known history of moderate to severe depression; currently uncontrolled severe hypertension (≥180/120 mmHg) despite treatment; known history of uncontrolled hyperthyroidism (thyrotoxicosis), severe renal impairment i.e., creatinine clearance of less than 30 ml per minute (Cockcroft- Gault equation) or receiving long-term dialysis, or known diagnosis of severe liver disease as determined by the site physician or documented in the clinical history.
Study of HTD4010 in Healthy Volunteers

To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers

Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.

Eligibility Criteria:
For volunteers in SAD:

Inclusion Criteria:

1. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
2. Non-diabetic, fasting plasma glucose \< 5.6 mmol/L
3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months.

   Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of Study Drug.
4. Ability to provide written informed consent.

Exclusion Criteria:

1. Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg at screening.
2. Pregnant or lactating women
3. Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
4. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. Use of ≤2g paracetamol per day is allowed prior to and during the study at Investigator discretion.
5. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
6. History of any major surgery within 6 months prior to Screening
7. History of any serious adverse reaction or hypersensitivity to any of the product components.
8. Use of parenterally administered proteins or antibodies within 12 weeks of screening.

etc.
Effect of Nilotinib in Cerebellar Ataxia Patients

This is an institutional cohort study. Patients confirmed with spinocerebellar ataxia (SCA) and taking or planning to take Nilotinib (Tasigna®) are enrolled in this study. The daily dose of Nilotinib is 150mg-300mg and the patients will be followed up at 1, 3, 6, and 12 months. Rating scale for Friedreich's ataxia I and II and Barthel index are used as general function and daily living performance index. Scale for assessment and rating of ataxia (SARA) are used as an objective measure of cerebellar function. Adverse drug reactions are evaluated based on CTCAE version 4.0.

1. Patients taking Nilotinib 1-1.Baseline information: demographics, genetic type of SCA, brain MRI, electrocardiography, routine blood evaluations 1-2. Time point of evaluation: At initiation of taking Nilotinib, 1, 3, 6, and 12 months 1-3. Evaluation items (at each time point) Routine check-up: electrocardiography, routine blood evaluations Adverse events: CTCAE version 4.0 Daily living performance: Barthel index General function: Friedreich's ataxia I and II 1-4. Change of drug dose Based on the attending physician's decision
2. Patients planning to take Nilotinib 2-1.Baseline information: demographics, genetic type of SCA, brain MRI, electrocardiography, routine blood evaluations 2-2. Time point of evaluation: Baseline, 1, 3, 6, and 12 months 2-3. Evaluation items (at each time point) Routine check-up: electrocardiography, routine blood evaluations Adverse events: CTCAE version 4.0 Cerebellar function: Scale for assessment and rating of ataxia (SARA) Daily living performance: Barthel index General function: Friedreich's ataxia I and II 2-4. Change of drug dose Based on the attending physician's decision

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as chronic cerebellar ataxia
* Confirmed as spinocerebellar ataxia by gene test

Exclusion Criteria:

* Laboratory abnormalities that could interfere with the proper use of Nilotinib QTc interval \>450ms on initial electrocardiograph, Hb \<8.0, WBC\<2000, ANC \<1600, PLT \<140,000, AST \>200, ALT\>200, ALP\>575, Positive HIV serology, active hepatitis B
* Unstable mental or physical status that could interfere with precise evaluation and proper management of SCA Heart failure (NYHA Grade III or IV), history of major heart disease Pregnancy, on breast feeding
Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥ 2.
* Under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula.
* Requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake.
* Free living in the community or is residing in a nursing home.
* Conforms to the requirements set forth on the study product label.

Exclusion Criteria:

* Currently taking or has taken antibiotics within 2 weeks prior to enrollment.
* Consuming food PO.
* Current active cancer and the study physician determines that the subject is not suitable for the study.
* History of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus.
* Renal or liver failure.
* Pregnant as demonstrated by self-report.
* Severe auto immune disease (per physician's discretion) and is on immuno-modulating therapy.
* History of allergy to any of the ingredients in the study product.
* Active Human Immunodeficiency Virus (HIV).
* Known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol.
* Condition that is contraindicated to tube feeding the study product.
* Taking part in a non-approved clinical trial.
Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea

This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.

A randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore. An informed written consent was taken from parents of the children. Ethical issues considered and maintained throughout the study. Then all children were randomly divided in two groups by using lottery method. In group 1; children were given yogurt while in group 2, children were given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients were followed-up till resolution of symptoms and discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Children of age 4-24 months presenting with acute diarrhea
* Both gender

Exclusion Criteria:

* Children on antibiotic therapy within 48 hours prior to presentation
* Malnourished children (-2SD as per WHO criteria)
* Children with severe dehydration requiring IV fluids
* Children \< 4 months of age (as weaning not started yet)
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
* Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)

Exclusion Criteria:

* The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
* Known or suspected allergy to yeast
* Known bleeding or hematologic disorder
* Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
* Smoking more than 10 cigarettes/day or equivalent
* Not able or willing to refrain from smoking whenever required for the trial procedures
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the physician
* Excessive consumption of a diet deviating from a normal diet as judged by the physician
* Strenuous exercise as judged by the physician within 4 days prior to trial start (screening)
* Surgery or trauma with significant blood loss (500 mL or more blood) within 3 months prior to trial start (screening)
* Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods. Adequate contraceptive measures include that the subject uses a condom during intercourse or that the partner practices adequate conception (sterilisation, hormonal intrauterine devices and oral contraceptives).
Use of Simulation to Improve VAD Self-management

This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). The investigators expect this training will improve self-management skills, and reduce VAD-related infections and re-hospitalizations. In addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.


Eligibility Criteria:
Patient Inclusion Criteria:

* being a previous or current VAD implantation patient,
* age \>18,
* English-speaking,
* receiving implantation and VAD care at Northwestern Memorial Hospital (NMH),
* meet hospital criteria for VAD implantation.

Caregiver inclusion criteria:

* being a caregiver identified by a previous or current VAD implantation patient,
* age \>18, and
* English-speaking.

Exclusion Criteria:

* Vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). Fetuses and neonates are not the focus of our study.
* Pregnant women will not be included since pregnancy is a contraindication to VAD implantation It is possible that VAD caregivers may be pregnant at the time of the study.
* Patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures.
* Lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for VAD implantation
Hyperopic LASIK With Crosslinking Versus Standard LASIK

Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).

Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.

Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

Exclusion Criteria:

* Patients with previous intraocular or corneal surgery, active corneal disease
Reliability of IUS in Crohn's Disease

Transabdominal intestinal ultrasound (IUS) is gaining acceptance as a point-of-care test to objectively assess disease activity in Crohn's disease (CD).

In order to incorporate individual parameters in a future definition of transmural healing, and for the consistent application of IUS as a modality to assess treatment outcomes and establish therapeutic targets to ensure comparability between future studies, the inter-observer agreement should be determined for all relevant parameters.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease evolving for at least 1 months
* Patient older than 18 years
* Patient covered by French national health insurance
* Written informed consent

Exclusion Criteria:

* Pregnant women or breastfeeding
* Minor
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study

Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for tic disorders. A recent scientific review of research priorities completed by the Tourette Syndrome Association recommended widespread dissemination of CBIT as an important next step in services delivery research. Given early evidence that occupational therapists can deliver CBIT effectively, a dissemination strategy using occupational therapists may improve accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of this study is to develop and test a training and dissemination model with occupational therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The investigators have adapted CBIT, the gold-standard behavioral intervention program for children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across the country.

CBIT training materials designed by the study team have been used to train occupational therapists (OTs) at WC/NYPH and UAB to deliver CBIT, and data has been collected to measure training acceptability.

OTs will be supervised in the practice of CBIT with youth in the New York City and Birmingham areas. Pre- and post-treatment assessment measures will be collected from 16 families (8 from each site) to evaluate intervention acceptability, feasibility, and fidelity. Patient and parent satisfaction of CBIT-OT will also be documented. The investigators will look within subjects to ascertain change in reported tic severity.

This study is designed to determine the feasibility and acceptability of treatment, feasibility of research design, as well as demonstrate the ability to disseminate the study protocol to a new care discipline in methodologically rigorous fashion across multiple sites.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-17
* Presence of motor and/or vocal tics for at least 6 months
* Tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions Severity (CGI-S) score of 4 or higher (tic symptoms clearly noticeable to family and occasionally to families and associated with at least some minimal level of distress and/or interference.
* IQ estimate of 70 or higher
* Comorbid disorder (e.g., ADHD, OCD,ODD) will be allowed provided that the tic symptoms are of primary concern to parents and comorbid symptoms are not of sufficient severity to require immediate treatment other than that provided by the current study.
* Pre-existing stable medication, tic or otherwise, will also be allowed provided the family agrees to refrain from med changes over the course of the study if at all possible.
* Sufficient command of the English language to comply with study protocol.

Exclusion Criteria:

* Free of PDD or other developmental disability