cyrilzakka/clinical-trials huggingface dataset:
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization

Distal radius fracture (DRF) is a common fracture of which the incidence appears to be increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.

In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment with plaster cast or brace for one-three weeks. Despite the advice in the guideline and despite several studies from the 90's showing that plaster cast treatment of a stable DRF for one week is safe, the usual length of plaster cast treatment for stable DRF is four-six weeks. In addition, recent studies have also shown that a long period of immobilization can lead to more post traumatic pain by increasing disuse and kinesiophobia.

This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF is unnecessary.

The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. In addition, this feasibility study will be used to define the sample size of the future RCT.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Isolated acute distal radius fracture
* Closed reduction is not performed
* Non-operative treatment with cast immobilisation
* Understanding of Dutch language

Exclusion Criteria:

* Under the age of 18 or older than 75 years
* Multiple injured patient
* Reduction is indicated/performed
* Operative treatment
* Not understanding of Dutch language
Minocycline in Clinically Isolated Syndromes (CIS)

The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome).

A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.

* Minocycline 100 mg bid orally compared to identical placebo
* Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event suggestive of multiple sclerosis (At baseline participants may meet 2010 McDonald diagnostic criteria for MS, but not 2005 criteria)
* Men and women, aged 18-60y, first event within the previous 180 days; brain magnetic resonance imaging (MRI) with at least two brain T2 lesions which are at least 3 mm in diameter, and at least one of which is ovoid or periventricular or infratentorial.
* Up to 24 months of study drug (Up to 12 months of study drug for patients recruited after December 31, 2012)
* Patients will be discontinued from the study when they convert to McDMS based on the 2005 McDonald definition.
* 12 Canadian MS Clinics
* A total of 154 patients will be randomized. Because 30% of screened patients with CIS who are clinically eligible are not expected to meet the MRI criteria for inclusion, up to 280 patients will be screened.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years.
* First focal clinical episode suggestive of demyelinating disease within the previous 180 days (measured from onset of the first symptom to treatment start), based on the appearance of a neurological abnormality, present for at least 24 hours.
* Objective clinical evidence must be present or documented. Patients will be included irrespective of whether the first clinical demyelinating episode was monosymptomatic (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence of more than one lesion).
* At least two lesions on the T2-weighted brain MRI\* scan at least one of which is ovoid or periventricular or infratentorial. MRI eligibility will be determined centrally by the UBC MS/MRI Research Group.\*One lesion on spinal MRI may substitute for one brain lesion as per the 2005 McDonald Criteria.
* Sexually active women of child-bearing potential must agree to use adequate contraception.
* Written informed consent

Exclusion Criteria:

* Any disease other than MS that could better explain the patient's signs and symptoms.
* Any previous clinical event reasonably attributable to acute demyelination, regardless of whether medical attention was obtained.
* Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for bilateral optic neuritis but must be obtained prior to randomization. Waivers must be approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.

The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.

Essential tremor is a very common form of tremor, occurring in up to 5% of people. It may be inherited. In 90% of patients, the tremor is in the hands; however, it can also be in the head, voice, legs, jaw, and tongue. Essential tremor may be treated by the blood pressure medicine propranolol or the anti-seizure drug primidone. The drawbacks of these drugs are that they tend to lose effectiveness over time, and they may cause side effects. Researchers believe that topiramate, an anti-seizure drug, may be effective in treating essential tremor. In this double blind, placebo-controlled study, patients with essential tremor will start at a low dose of topiramate (25 milligrams) or placebo. The dose will be gradually increased over 12 weeks to a maximum of 400 milligrams daily, taken in two divided doses. Then, each patient will stay on the established dose for the next 12 weeks. During the next phase of the study, the patients will slowly reduce the dose until they stop taking the study drug, after which, patients have the option of taking up to 600 milligrams of topiramate (not placebo) in a 14-week extension of the study. This study was designed to investigate the hypothesis that topiramate will be more effective than placebo in the treatment of essential tremor as measured by the Clinical Rating Scale for Tremor (TRS) and is well tolerated. The TRS is a three part scale that measures tremor location/severity rating, specific motor tasks/function rating, and functional disabilities resulting from tremor. Safety evaluations are assessed throughout the study.

Topiramate or placebo, starting with a dose of 25 mg, then gradually increased over 12 weeks up to 400 mg daily (two 100-mg tablets taken by mouth twice a day) and continued on this dose for 12 weeks in the maintenance phase; up to 600 milligrams of topiramate in the open-label phase.

Eligibility Criteria:
Inclusion Criteria:

* Current symptoms of essential tremor based on the Tremor Investigational Group (TRIG) criteria
* Dominant upper extremity posture or action intention tremor of 2 (moderate) to 4 (severe)
* In good health otherwise

Exclusion Criteria:

* Patients with abnormal neurologic signs other than essential tremor
* Taking more than one anti-tremor medication
* Taking drugs known to cause tremors
* With physical damage to the nervous system or Parkinson's disease
* Known to be abusing drugs or alcohol
* Women who are pregnant or breast-feeding
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

Several lines of evidence show energy metabolism and redox dysregulation in bipolar disorder and psychotic disorders. Ketogenic interventions targeting energy metabolism are promising therapeutic approaches to improve mood and psychosis in bipolar disorder and other psychotic disorders. Early intervention is also critical to helping people achieve their goals for recovery after a first episode. Investigators aim to use multimodal imaging and metabolic measures to study the effects of a ketogenic diet intervention on energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder. This 12-week randomized controlled trial will assess the benefits of a ketogenic diet in combination with treatment as usual compared to a standard diet. Investigators will measure the effects of nutritional ketosis on brain redox and energy metabolism and other neurometabolic markers using magnetic resonance spectroscopy. Furthermore, investigators will measure the effects of the ketogenic diet on mood and psychotic symptoms and metabolic measures such as insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 45.
* Ability to adhere to study diets.
* Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.
* Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening
* Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.

Exclusion Criteria:

* Unable to sign informed consent
* Contraindication to magnetic resonance (MR) scan (including claustrophobia)
* Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)
* Current DSM-5 substance use disorder
* Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception
* Have a body weight of over 350 lbs or a body mass index (BMI) \<20
* Score above 15 on the Young Mania Rating Scale (YMRS)
* History of significant head injury
* Current cancer diagnosis
* Current diagnosis of type 1 or type 2 Diabetes Mellitus
* History of gastric bypass surgery or any weight loss surgery
* Concomitant treatment with Propofol
* Familial hypercholesterolemia
Pulse Waves and Tongue Diagnosis Differences Between Follicular and Luteal Phase in Normal Healthy Women

We hypothesized that there's difference between follicular phase and luteal phase of normal women in radial pulse waves and tongue figures.

As comparing with follicular and menstrual phases of the cycle, in women during the luteal phase, the heart rate, body temperature, foot skin temperature and body weight were significantly increased. Tongue inspection and pulse examination are two methods that Chinese medical doctors are used in the diagnosis of patterns. Pulse wave analysis of the radial artery is a non-invasive, widely applicable technique for assessing cardiovascular function. Radial artery waveforms have been demonstrated being associated with the blood pressure wave of ascending and central aorta, the function of left ventricle , the arterial wall properties and the endothelial function. Even when measure locally, carries characteristic information from the whole arterial system because of reflection of waves at distinct sites of the arterial system. Examination of the changes of the arterial pulse wave between follicular phase may offer valuable insights into cardiovascular physiologic feature in menstrual cycle. The objective of this study was to test the hypothesis that the cyclic variations in hemodynamic and volume parameters during the menstrual cycle among normal healthy women. To that end we compared the following parameter of radial pulse contour between late follicular and late luteal time point: percussion wave, the difference between dicrotic wave and dicrotic notch, and the area of the wave.

Eligibility Criteria:
Inclusion Criteria:

1. Nornal period I/D=28-35/3-5 (eumenorrheic)
2. age:21-40
3. No use of oral pills in past 6 months
4. BMI1: 8.5-24.9
5. No history of smoke, alcohol or drug abuse
6. No regular exercise in past 3 month

Exclusion Criteria:

1. CVD, hepatic, renal disease
2. psychological disease
3. Thyroid disease
Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors

Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the arteries and heart.

Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is associated with long term adverse cardiac and vascular effects which include:

1. Increased arterial stiffness and left ventricular mass
2. Abnormalities in left ventricular systolic and diastolic function
3. Increased oxidative stress, inflammation and collagen turnover


Eligibility Criteria:
Inclusion Criteria:

* Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust

Current nationally set Exclusion Criteria:

* Diabetes mellitus
* Atrial fibrillation
* Left ventricular dysfunction (ejection fraction \<40% on transthoracic echocardiography)
* History of cardiovascular or pulmonary disease
* Evidence of hypertensive end-organ damage.
Financial Incentive for Smoking Cessation in Pregnancy

Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;
2. To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;
3. To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

Multicenter, national study. Participants are pregnant smokers of at least 18 years old, smoking at least 5 manufactured or 3 rolled-on-their-own cigarettes per day. They will be randomly assigned according to a 1:1 ratio to receive either a financial incentive (20€/visit) to attend the 5 study visits (control group) or receive this show-up incentive plus an incentive for being abstinent at visit(s) on a progressive manner (treatment group). The incentives will be delivered as vouchers. Two hundred and forty pregnant smokers will be randomized into the control and treatment groups, respectively. The study will be run in several maternity wards across France all of whom routinely treat pregnant smokers.

Expected results

* Financial incentives rewarding progressive abstinence from smoking will increase abstinence rate more than lack of financial incentives.
* Forward looking and time consistent women will be more likely to stop smoking.
* If the clinical efficacy and cost effectiveness are demonstrated, financial incentives can be introduced as a standard intervention in helping pregnant smokers quit.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women
2. At least 18 years old
3. Smoking at least 5 manufactured cigarettes or 3 rolled-on-your-own cigarettes
4. Of \<18 weeks of gestation
5. Motivated to quit smoking
6. Affiliated to social security system
7. And who signed the written informed consent form

Exclusion Criteria:

1. Psychiatric disorders
2. Use of other tobacco products (pipe, cigar, oral tobacco) than cigarettes
3. Use of bupropion or varenicline
4. Use of electronic cigarettes during the current pregnancy
5. Women already included in a biomedical research
Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms

This study was designed to identify high platelet reactivity (HPR) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (LTA). For HPR patients, higher ischemic stroke rate maybe occurred, and we hypothesis that dose adjustment of aspirin and clopidogrel based on LTA monitoring maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial stent implantation at early periprocedural period and 1 month follow-up period.

For the patients of unruptured intracranial aneurysms with stent placement, standard antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most effective antiplatelet regimen in reducing ischemic complications. However, despite the use of standard antiplatelet therapy, a number of patients continue to have ischemic events. A hypothesis is that high platelet reactivity (HPR) patients identified by platelet function test have higher ratio of the ischemic events, and dose adjustment of HPR patients reduces the rate of the ischemic complications at early periprocedural period and follow-up period.

Objectives: The study aim to evaluated the superiority of the strategy of platelet function test(Monitoring Arm) with the modified strategy in HPR patients compared to the standard strategy (Conventional Arm) whether reduce the primary endpoint after intracranial stent implantation at early periprocedural period (7 days) and 1 months follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 80, male or non-pregnant female;
2. patients have unruptured aneurysm who plan to undergo intracranial stent placement;
3. patients with less than 2 of modified Rankin scale score at the day of enrollment;
4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.

Exclusion Criteria:

1. The complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc;
2. Simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, Intracranial arteriovenous fistula, etc;
3. Patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor;
4. Patients with preoperative prophylactic use of tirofiban;
5. Patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy;
6. Patients with thrombocytopenia (platelet count \<100,000/mm3 within three months before enrollment);
7. patient using anticoagulant;
8. Pregnant or lactating women;
9. Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
10. Poor compliance patients.
Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size

In this study the effectiveness of the use of Cole formula and USG were compared in determining the number of the appropriate uncuffed ETT to be used for clinically adequate ventilation.

Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.

Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation, were enrolled in this study. Once patients were properly positioned after premedication and anesthesia induction, the subglottic diameter was measured using ultrasonography, and endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients were entubated with uncuffed ETT with sizes based on the patient's age in compliance with current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring had passed through the vocal cords and breath sounds were confirmed to be equal by auscultation. The size of the used ETT was compared with the size estimated from the subglottic diameter measured by ultrasonography to the size calculated with the Cole formula

Eligibility Criteria:
Inclusion Criteria:Children between 2 and 10 years of age, in the ASA I-II classification for whom elective surgery

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Exclusion Criteria:

Children having a diagnosed syndrome, any anomaly of the upper respiratory tract and the head-neck region, recent or active upper respiratory tract infection, previous tracheastomy, requiring nasotracheal entubation, requiring surgery on an emergency basis and being in the ASA III-IV classification -