cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA.

Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.

The ROCK trial is a two-arm multicentre investigator-initiated clinical randomised controlled superiority trial evaluating the effectiveness of a comprehensive individually tailored rehabilitation intervention focusing on supporting labour marked participation of survivors of out-of-hospital cardiac arrest compared to usual care, with primary endpoint measured after 12 months follow-up.

The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. The investigators hypothesize that the intervention will result in a higher-level labour marked attachment one year after hospital discharge in addition to increased health-related quality of life.

A full statistical analysis plan describing all details have been developed. In short, data from the national register on social transfer payments (DREAM database) will form the basis for the primary outcome. The primary outcome is labour market participation, defined as the proportion of employment vs. on social transfer payment, and the primary end point will be collected 12 months after hospital discharge.

Eligibility Criteria:
Inclusion criteria:

* All adult survivors with first time out-of-hospital cardiac arrest
* Discharged from the Hospitals will be assessed eligible for inclusion

Exclusion criteria:

* Survivors who prior to the cardiac arrest were not part of the labour force with at least two years until they are qualified to receive retirement state pensions
* Patients that cannot understand and fulfil the study surveys (in Danish)
* Patients with short witnessed cardiac arrests with return of spontaneous circulation estimated less than 4 minutes and immediate awakening without ICU treatment
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI

The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.


Eligibility Criteria:
Inclusion Criteria:

* Admitted into the ICU
* Aged 18 years or older
* Mechanically ventilated
* Arterial line placed
* Vigileo/Flotrac System being used for guidance of fluid management

Exclusion Criteria:

* Pregnancy
* Prisoner status
* Extreme hemodynamic instability
* Multiple vasopressors in use with questionable peripheral blood flow
* Lack of appropriate sites for sensor placement
* Patient or patient's legal representative refusal
Mucopolysaccharidosis Type II Natural History

Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is caused by a deficiency of iduronate-2-sulfatase (IDS) leading to an accumulation of glycosaminoglycans (GAGs) in tissues of MPS II patients, resulting in characteristic storage lesions and diverse disease sequelae, and in patients with the more severe form of the disease, irreversible neurocognitive decline and higher morbidity and mortality than in patients with the attenuated form of the disease.

There is currently limited information on the natural history of MPS II, especially with respect to neurocognitive decline in patients with the more severe form of the disease. This study is planned to be an observational medical records review study (data collected retrospectively and no investigational product treatment or procedures) in subjects with the severe form of MPS II. Collectively, the data may inform the design of future MPS II gene therapy treatment studies and may be utilized as historical comparative control data.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of MPS II confirmed by enzyme activity as measured in plasma, fibroblasts, or leukocytes
2. The subject has at least one of the neurocognitive assessments listed below, which occurred prior to age 6 and in or after 2006 in their medical records.

   1. Bayley Scales of Infant and Toddler Development (BSID), any version
   2. Differential Ability Scale (DAS), any version
   3. Griffiths Mental Development Scale (GMDS), any version
   4. Kaufman Assessment Battery for Children (KABC), any version
   5. Kinder Infant Development Scale (KIDS)
   6. Kyoto Scale of Psychological Development (KSPD), any version
   7. Leiter International Performance Scale (LIPS), any version
   8. Mullen Scales of Early Learning (MSEL), any version
   9. Vineland Adaptive Behavior Scales (VABS), any version
   10. Wechsler Intelligence Scale for Children (WISC), any version
   11. Wechsler Preschool and Primary Scale of Intelligence (WPPSI), any version
3. If the subject has undergone hematopoietic stem cell transplantation (HSCT), they must have at least one neurocognitive assessment prior to HSCT.
How to Treat Opiate Withdrawal in Neonates

Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

Background: Neonatal narcotic abstinence syndrome is an important medical, social and financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best.

Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. Infants with severe malformation are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. The masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way.

A total of 120 infants, 40 in each group will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Neonates of mothers who consumed opiates during pregnancy
* Born after 34 completed weeks of pregnancy
* Parents' informed consent

Exclusion Criteria:

* Preterm birth before 34 0/7 gestational weeks
* Severe malformation
* Illness requiring respiratory assistance or catecholamines
* Negative meconium drug test
A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING)

The main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in Chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - EGFR exon 20 insertion mutation) during normal clinical practice.

Participants will be treated with mobocertinib as per their normal routine. Data for this study will be collected from the available medical records of a participant.

This is a non-interventional, prospective, observational study of participants with EGFR ex20ins positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who received mobocertinib in China's routine clinical practice setting. The primary objective of this study is to assess the real-world time-to-treatment discontinuation (rwTTD) of mobocertinib in study participants.

The study will enroll approximately 120 participants. Participants will be enrolled in the following cohort:

• Mobocertinib

Participants will be treated with mobocertinib as per their normal routine treatment. Data for this study will be collected from the available medical records of a participant every 3 months until the end of treatment and follow up (up to 18 months).

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with histologically/cytologically confirmed diagnosis of EGFR ex20ins positive locally advanced or metastatic NSCLC by local hospitals.
2. Participants who received mobocertinib as treatment therapy in routine clinical practice; the decision to treat with mobocertinib had to be made independently by physician before enrollment into the study.
3. The decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study.

Exclusion Criteria:

1. Participants who are participating in other NSCLC interventional clinical study during the treatment of mobocertinib in this study will be excluded;
2. Other situations that the investigators consider not suitable for participation in this study.
Glaucoma Adherence Study

The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

This study was conducted in France, UK, Italy, and Netherlands. An identical study was conducted in Spain under Protocol ID EMD-07-02. A combined enrollment number is presented.

Eligibility Criteria:
Inclusion:

* Provide informed consent.
* Able to follow instructions and be willing and able to attend required study visits.
* Able to read and complete study questionnaires.
* Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye.
* Intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial.
* Currently treated with DuoTrav alone, dosed in the evening for at least for 30 days, at Visit 1.
* Best corrected visual acuity of 20/200 Snellen or better in each eye.
* Intraocular pressure ≤ 30 mm Hg in both eyes.
* Evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication.
* Agree that their adherence could be improved by the intervention with the dosing aid described in this study.
* Other protocol-defined inclusion criteria may apply.

Exclusion:

* Presence of other primary or secondary glaucoma not listed in inclusion criterion.
* Any abnormality preventing reliable applanation tonometry in the study eye(s).
* Any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
* Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
* Unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation.
* History of, or at risk for uveitis or cystoid macular edema (CME).
* Any physical disability which prevents the accurate use of the Travalert™ dosing aid.
* Unable to accurately instill the travoprost/timolol fixed combination in the evening.
* Other protocol-defined exclusion criteria may apply.
Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.

The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

Older patients who agree to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment. Correlation analysis will be done with the different measurement.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 years old
* Osteoporosis diagnosis confirmed by Dual-energy X-ray Absorptiometry

Exclusion Criteria:

* Neurocognitive disorders preventing the expression of informed consent
* Patients who cannot undergo an examination in a static position
* Lack of a measurement site (muscle resection or amputation)
* Any state of dehydration or water inflation
* Patient with legal protection measure
Long-term Cardiac Monitoring in Epilepsy

The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.

Most cardiac studies have investigated patients with intractable focal epilepsy who have a high risk for co-morbidities, accidents, injury and SUDEP. This is confounded by the major antiepileptic drug burden in this population. Very little, however, is known about the risk of cardiac arrhythmias in patients with a lower seizure burden, i.e. patients with infrequent focal seizures and/or those without secondarily generalized convulsions. Furthermore, no chronic cardiac data is available in patients with epileptic encephalopathies especially given the fact that some of these patients are known to carry mutations that increase the risk for cardiac arrhythmias.In addition, periods of reduced cerebral blood flow during tachy or brady arrhythmias may exacerbate seizure severity and during. Diagnosing and treating these arrhythmias may not only prevent adverse cardiac events, but also reduce seizure burden. This study primarily aims to compare the frequency of cardiac rhythm abnormalities in patients with epilepsy of different severity, assess the long-term cardiac risk and evaluate the possible preventive role of anti-arrhythmic agents and/or cardiac pacemaker/defibrillator needs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 years with ability to consent.
2. No primary cardiac abnormality.
3. Ability to receive an implantable loop recorder and tolerate the procedure.
4. Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy)

Exclusion Criteria:

1. Cardiac disease of any type
2. Known epilepsy genetic disorder with potential cardiac compromise
3. Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder
4. Chronic psychosis
5. Severe MR without reliable caregiver monitoring (what is MR?)
6. Already included in another clinical trial that will affect the objectives of this study.
7. Life expectancy is less than 1 year
Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy

People with diabetes can have nerve damage in their extremities (peripheral neuropathy), and this can lead them to being less able to maintain their balance when they are standing, walking or performing complex movement tasks in their day-to-day life. This results in them being more prone to falls, and consequent injuries. The purpose of this study is to determine whether providing strength and balance retraining (in the form of specific physical exercises or activities) can help people with diabetic peripheral neuropathy regain their ability to maintain their balance, increase their confidence in performing balance-based activities and improve their quality of life.

Individuals with diabetic peripheral neuropathy (DPN) comprise 16-24% of patients with diabetes mellitus in Singapore, and this is set to rise with the increasing prevalence of diabetes. DPN is also associated with the greatest reduction in health related quality of life (HRQoL) among all diabetic complications, specifically PCS (Physical health Component Summary) and its sub-components, physical functioning and physical role. However, there is currently no intervention that targets individuals with DPN for improvements in HRQoL and functional status.

The investigators hypothesise that a targeted intervention providing strength and balance training will improve HRQoL and functional status in patients with DPN, which will be sufficiently large relative to increases in cost to make the intervention cost-efficient.

The specific aims of the study are to test the effectiveness of a structured strength and balance training intervention in 1) improving the physical health component summary (PCS) measure of health related quality of life, 2) functional status, and 3) assessing cost-utility of the intervention, in individuals with diabetic peripheral neuropathy (DPN).

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 40 - 75
* Clinical diagnosis of Type II Diabetes Mellitus
* Presence of peripheral neuropathy (defined as neurothesiometer reading greater than 25 V and/or positive monofilament test in 2 or more sites in either foot)

Exclusion Criteria:

* Foot ulceration/ infection/ amputation
* Medical contraindication for physical activity or physiotherapy
* Non-diabetic neuropathy
* Orthopaedic/ Surgical/ Medical conditions affecting functional mobility and balance not due to diabetes or neuropathy (E.g. Stroke, Prosthesis use, Osteoarthritis)
* Retinopathy
* End-Stage Renal Disease requiring dialysis
* Congestive Heart Failure
Dentinal Hypersensitivity Reduction

The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.


Eligibility Criteria:
Inclusion Criteria:

* Sign an Informed Consent Form;
* Male or female 18 to 70 years of age, inclusive;
* Be in good general health as determined by the study investigators;
* Available for the seven (7) days duration of the study;
* Must present two (2) sensitive teeth which must meet ALL of the following criteria:

  * Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
  * Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA);
  * Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale

Exclusion Criteria:

* Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
* Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
* Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
* Sensitive teeth with a mobility greater than one;
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
* Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics;
* Participation in any other oral clinical study for the duration of this study
* Self-reported pregnancy and/or currently breastfeeding;
* Allergies to oral care products, personal care consumer products, and/or their ingredients;
* Medical condition which prohibits not eating/drinking for 4 hours.