cyrilzakka/clinical-trials huggingface dataset:
Prescription of Physical Exercise Through Mobile Application in Elderly

Physical inactivity is a health problem that affects people worldwide and has been identified as the fourth largest risk factor for overall mortality (contributing to 6% of deaths globally). Many researchers have tried to increase physical activity (PA) levels through traditional methods without much success. Thus, many researchers are turning to mobile technology as an emerging method for changing health behaviours.The study consists of a physical activity intervention through a mobile application in elderly. The study is a 3x2 model, in which the sample is distributed in three study groups (over 53 years) and were evaluated at 10 weeks from baseline.

Objectives of the study:

* Evaluate effectiveness of a physical exercise program for 10 weeks to improve fitness, cardiovascular, anthropometric and body composition parameters in people over 53 years.
* Examine effects of exercise intervention delivered through a mobile application (WhatsApp) on fitness, cardiovascular risk factors, anthropometric and body composition in people over 53 years.

Hypotheses of the study:

* An intervention of exercise administered via mobile application (WhatsApp) is effective in reducing cardiovascular risk factors in people over 53 years.
* An intervention of exercise administered via mobile application (WhatsApp) is effective to increase physical fitness in people over 53 years.
* An intervention of exercise administered via mobile application (WhatsApp) is effective in reducing BMI, percent body fat; and in increasing the percentage of muscle mass in people over 53 years.
* 10-weeks face-to-face intervention of physical exercise obtains greater improvements in fitness parameters than an intervention delivered via mobile application in people over 53 years.
* 10-weeks face-to-face intervention of physical exercise obtains greater improvements in anthropometric and body composition than an intervention delivered via mobile application in people over 53 years.

Eligibility Criteria:
Inclusion Criteria:

* Have own mobile phone and Internet
* Be clinically stable
* Be able to perform physical activity
* Be able to understand and complete the informed consent
* Ability to cope assessment tests

Exclusion Criteria:

* Unable to perform physical activity
* Have an acute or chronic disease
* Have medical conditions or other physical problem that needs special attention (history of fracture of any upper or lower limb, dementia, psychological problems, neuromuscular disease, history of myocardial infarction, osteoporosis, cancer, diabetes).
Treatment of Nicotine Dependence and Acute Depression

The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 at the beginning of the study
* Smoking at least 10 cigarettes a day (1/2 pack)
* Meets DSM-IV criteria for major depressive episode

Exclusion Criteria:

* Currently pregnant
* Currently breastfeeding
* Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis
* History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
* Family history of seizures
* Currently using intravenous drugs
* Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
* Currently using any over-the-counter stimulants and anorectics (diet pills)
* Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
* Currently on NRT or bupropion (Zyban)
* Current or past diagnosis of anorexia nervosa
* Previous allergic response to fluoxetine, bupropion, or NRT
* Previous failed quit attempt using NRT and bupropion in combination
* Current suicidal ideation
* Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence
Pain Management of Children With Appendicitis in the Emergency Department (ER)

The aim of this retrospective study is to determine the percentage of children with appendicitis who were given analgesics or opioids in the ER, to reduce their pain.


Eligibility Criteria:
Inclusion Criteria:

* Children with appendicitis

Exclusion Criteria:

-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated. This trial plans to evaluate approximately seven single dose-levels of RO7049665 or matching-placebo during dose-escalation in approximately 40 participants.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers, 18 to 45 years of age, inclusive;
* Absence of evidence of any active or chronic disease;
* Body mass index (BMI) of 18-30 kilograms per square meter (kg/m\^2), inclusive;
* Contraception requirements: refrain from heterosexual intercourse or use contraceptive measures, and agreement to refrain from donating sperm.

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis;
* Clinically significant abnormalities (as judged by the Investigator) in laboratory test results;
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study;
* History of hypersensitivity to biologic agents or any of the excipients in the formulation;
* Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection;
* Prior administration of aldesleukin, or interleukin-2 (IL-2) derivatives.
Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus

The purpose of the study is to determine if the so called pulsatility curve, which describes the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery. The main hypotheses of the study are:

1. The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in INPH patients. With a "fixed" shunt opening pressure, the preoperatively assessed potential pulse amplitude reduction (determined by analysis of the pulsatility curve) predicts postoperative improvement in gait velocity and cognitive functions.
2. A postoperative pulsatility curve can be used to further optimize ICP pulsatility by guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve three months postoperatively will increase improvement, but not complications, compared to a shunt with "fixed" opening pressure.

Based on these hypotheses, three specific aims for the study have been defined:

1. To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude.
2. To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery.
3. To compare outcome six months after surgery and complications rates between INPH patients with a "fixed" opening pressure versus those where the shunt has been adjusted based on the pulsatility curve, three months after the shunt insertion.


Eligibility Criteria:
Inclusion Criteria:

* Possible or probable INPH according to the INPH guidelines.
* Symptom duration ≥ 3 months
* Age ≥50 years
* Able to walk 10 meters with or without an assistant device.
* Decision to recommend shunt surgery based either on:

  * Improvement after cerebrospinal fluid (CSF) tap (i.e. positive tap test), or;
  * Increased CSF outflow resistance, or;
  * A combination of "typical" signs/symptoms + "typical" MRI findings;
  * A combination of a-c.

Exclusion Criteria:

* NPH due to hemorrhage, meningitis or stroke (secondary NPH).
* Symptom duration ≥ 5 years.
* Patients considered surgical risk.
* Baseline gait velocity \>1.1 m/sec (60 m/min) without assistant device
* Mini Mental State Exam score ≤ 20 points.
* Musculoskeletal condition precluding gait assessment.
* Severe hearing or visual impairment
* Medication in the form of warfarin or novel oral anticoagulant (NOAC)
* Insufficient pressure data below resting pressure during the CSF infusion investigation, i.e. no complete assessment of the pulsatility curve
Antibiotic Irrigation for Pancreatoduodenectomy

The purpose of this study is to determine if the routine use of antibiotic irrigation during pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.

The primary aim of this study is to test the efficacy of routine antibiotic irrigation in reducing superficial and organ space infections among patients undergoing pancreatoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and older;
* Open pancreatoduodenectomy for any diagnosis

Exclusion Criteria:

* Pregnant;
* Prisoners;
* Patients undergoing concomitant colectomy;
* Antibiotic allergy to study medication;
* Serum creatinine \> 2.0;
* Unable to provide informed consent
Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns

The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.

The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.

Eligibility Criteria:
Inclusion Criteria:

* Born between 24-36 weeks GA.

Exclusion Criteria:

* Chromosomal or congenital anomalies; congenital infections; \> grade II IVH;
* maternal use of tobacco, alcohol, or illicit drugs;
* significant abuse or malnutrition during pregnancy,
* failed ABR.
* No exclusions based on gender or ethnicity.
Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible.

TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels.

TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data. Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a clinical diagnosis of lateral epicondylitis.
2. Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be re-tested once at the discretion of the Investigator.
3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
4. Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of:

   1. Physical therapy
   2. Splinting
   3. NSAIDs

Exclusion Criteria:

Subjects with any of the following will be excluded from study participation:

1. Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
2. Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
3. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
4. Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics).
5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment

This study assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Each scenario was supported either by standard care methods or Mixed reality. The participants were randomised to at the start of the scenarios to determine which support they would receive first. The main outcome was to see if there was difference in error rates. This was assessed using the ICECAP multidimensional error capture tool. Secondary outcomes included teamwork, scenario completion, stress/cognitive load, and Mixed reality device user acceptability.


Eligibility Criteria:
Inclusion Criteria:

* All participants must provide consent to participate in the study
* Participants must receive a standardised HL2 headset and operational tutorial
* Participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study
* Participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects

Exclusion Criteria:

* Not currently working in emergency medicine/trauma setting
* No prior course completion (Advance trauma and Basic Life support)

Prior to the commencement of the study, all eligible participants were required to provide their consent to participate. Participants were then provided with a standardized HL2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. The tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. Participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.
Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.


Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 60 years old.
* either gender.
* American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria:

* Patient refusal to participate in research.
* History of preoperative neuromuscular disease.
* Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).
* History of psychiatric illness.
* History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.
* Coagulopathy disorder.
* Patients receiving magnesium supplementation.
* Chronic use of opioids.
* Current treatment with a β-blocker or calcium channel blocker.
Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
* Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT \< 10 seconds in both eyes

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
* Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry or has planned insertion/removal of glaucoma filtration shunts/devices during the study
* Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity
* Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
* Contact lens use anticipated during the study
Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction

The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be \> 18 and \< 85 years of age
* Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
* CEAP clinical classification: C4, C5, or C6 (enrollment of C4 and C5 subjects will be capped at 50, such that at least 50 C6 subjects can be enrolled)
* On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
* Undergoing iliofemoral and inferior vena caval venography with the intent to treat obstructive lesions

Exclusion Criteria:

* Subject cannot or will not provide written informed consent
* Previous venous stent implantation involving the study leg or inferior vena cava
* Previous venovenous bypass surgery involving the study leg
* Known metal allergy precluding endovascular stent implantation
* Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
* Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
* Severe, untreated (and readily treatable) superficial venous reflux (great saphenous vein \>7 mm in diameter, and/or small saphenous vein \>4 mm in diameter)
* Acute deep venous thrombosis involving either leg
* Known history of chronic total occlusion of the common femoral vein of the study leg.
* Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of lupus anticoagulant, etc.)
* Venous compression caused by tumor encasement
* Venous outflow obstruction caused by tumor thrombus
* Life expectancy of less than 6 months
* Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
* Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.


Eligibility Criteria:
Inclusion Criteria:

* Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
* Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
* Signed informed consent

Exclusion Criteria:

* Previously treated with Radium-223 for any reason
* Currently treated in clinical trials including other Radium-223 studies
* Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use