cyrilzakka/clinical-trials huggingface dataset:
The UHSM Cardiovascular Magnetic Resonance Study

This study aims to investigate the diagnostic and prognostic utility of cardiovascular magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR indices will be related to the presence and severity of cardiovascular disease and other markers of cardiovascular and health status.

Patients will undergo CMR scanning in the usual clinical manner. As part of the study, patients will undergo approximately 5 minutes of extra CMR scanning. Cardiovascular anatomical, structural and functional data will be recorded, including data pertaining to myocardial characteristics (e.g. extracellular volume, oedema, fibrosis, infarction, function, perfusion), pericardial disease; valvular disease; vascular structure and function.

Blood sampling will be performed on the same day as CMR scanning for assessment of serum/plasma markers of cardiovascular disease and health status, and DNA analysis. Health questionnaires will be completed on the day of CMR scanning.

Follow-up information regarding health status, demographics and concurrent medical conditions and treatments will be obtained over a 10 year period following CMR scanning.

Eligibility Criteria:
Inclusion Criteria:

Any adult patient undergoing clinically indicated CMR scanning at the UHSM CMR Unit.

Exclusion Criteria:

Age \< 18 years, imprisonment, inability to provide informed consent.
Diagnosis and Evaluation of Patients Needing Third Molar (Wisdom Tooth) Extraction and Patients With Chronic Facial Pain

This study provides a mechanism for evaluating patients for possible participation in NIDCR clinical research studies. NIDCR studies involve three major areas-pain, neurosensory mechanisms, and pain-relieving drugs-all of which have specific requirements and patient characteristics. No treatment is offered under this protocol; it is intended to facilitate patient recruitment into NIDCR studies.

Patients with unusual or unknown conditions that have or have not been diagnosed may be eligible for this screening study. Specific medical criteria for enrollment vary with the particular protocol for which the individual is being screened. Medical and dental histories will be obtained and participants will have a dental examination. Diagnostic procedures will be done in accord with standard medical and dental practice and may include X-rays, blood tests, and routine urinalysis, as appropriate. Participants found eligible for an active study may enroll in that study. Those who are not eligible for a current study may be re-evaluated for future studies within a year if they wish. After 1 year, participants for whom no appropriate studies are identified will be referred back to their primary doctor or referring physician or dentist.

This protocol is designed to screen individuals with either third molars ("wisdom teeth") in need of removal, or with chronic orofacial pain as potential research subjects.

Each individual will be thoroughly evaluated during the screening process, including past medical history and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risks and will be described in more detail in section III: "Study Procedures".

Once the screening process is completed and eligibility determined, the subjects will be informed of their options to participate in one or more of the current NIDCR research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician/dentist.

Eligibility Criteria:
INCLUSION CRITERIA

Varies with the particular protocol for which a patient is being screened.

Subjects with unusual or unknown conditions that require the establishment of a diagnosis, or those with an established diagnosis may be selected.

Subjects source for this study will be from referrals by medical and dental practitioners in the private sector, clinics, hospitals, dental-medical institutions, Commissioned Officers Dental Clinic, and the Occupational Medical Services at the National Institutes of Health.
Bioavailability Study of Leflunomide Tablets Under Fed Conditions

To compare the single-dose Bioavailability of Kali and Aventis

To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy female subjects under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8)
* Healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive)
* Indicate non-child bearing status by one of the following criteria:

Indication of successful hysterectomy. No spontaneous menses for al least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone(FSH) levels within postmenopausal range.

Indication of successful bilateral oophorectomy.

* Body weight within 20% of the appropriate weight for the subject's height and frame (as published in the 1983 Metropolitan Life Insurance Company Scale, Statistical Bureau)
* Negative for:

HIV Hepatitis B surface antigen and Hepatitis C antibody Urine tests for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).

Serum HCG consistent with pregnancy.

* No significant disease or clinically significant findings in a physical examination.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram(ECG)
* Subjects who have received leflunomide within 4 months must have an A77-1726(Metabolite) level below 0.01ug/ml and no subsequent administration of leflunomide since that test. Note: The 30 day screening limit does not apply to this inclusion criterion.
* Be informed of the nature of the study and given written consent prior to receiving any study procedures.

Exclusion Criteria:

* Subject fulfilling any of the following criteria will be excluded from the study.
* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* Known history or presence of:
* Hypersensitivity or idiosyncratic reaction to leflunomide and/or any other drug substances with similar activity.
* Alcoholism within the last 12 months.
* Drug dependence and/ or substance abuse.
* On a special diet within 4 weeks prior to drug administration(e.g. liquid, protein, raw food diet).
* Participated in another clinical trail or received an investigational product 30 days prior to drug administration.
* Donated up to 250 ml of blood in the past 45 days OR donated from 250 ml to 500 ml in the past 45 days OR donated 501 ml or more of blood in the past 56 days (based on the Canadian Blood Services guideline for blood donation).
* Requirement of any medication (prescription and/ or over-the-counter) on a routine basis, with the exception of hormonal replacement therapy, nutritional supplements and/or occasional use of common analgesics.
* Difficulty fasting or consuming the standard meals.
The Feasibility of Nintendo RingFit to Improve Balance and Muscle Strength of Elders

Background Existing findings have suggested that exergaming (i.e., exercise that requires people to move their body to play, providing an active gaming experience while serving as a form of physical activity), may have a potential to improve muscle strength and balance in older adults. However, no study has been conducted to investigate the effects of the Nintendo RingFit - an action role-playing game that aims to provide exercise training using a ring-shaped force sensor - in improving muscle strength and balance and possibly reducing falls in older adults living in the community.

Objective This study aims to investigate the feasibility of an exercise training program using Nintendo RingFit to improve balance and muscle strength among community-dwelling older adults.

Design A single-blind, randomized controlled feasibility trial.

Methods 30 participants will be recruited at local community-based elderly centers. Participants will be randomized to either the Nintendo RingFit-based exercise training group (NRE) or control group (CON) group with an allocation ratio of 1:1 by a researcher who will not participate in the recruitment and outcome evaluation. The NRE group will received an 8-week exercise training focusing on balance and lower limb muscle strength using the Nintendo RingFit. The CON group will receive a booklet and verbal instructions on the exercise for falls prevention, will be invited to join a leisure activity program (e.g., singing group) without any active exercise component for 8 weeks.

Outcomes The feasibility, acceptability and safety of the program will be examined at the end of the intervention. Postural balance, lower extremity strength, mobility, attention and executive function, fear of falling, and falls incidence of the participants will be assessed at 8 weeks.

Statistical analyses Descriptive statistics were presented for all variables. Chi-Square Test will be used to compare the difference in the proportion of fallers between the NRE and CON groups. Mann-Whitney U Test will be used to compare the functional outcomes between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* were 60 years old or above;
* had at least one fall in the past year;
* were able to walk independently without a walking aid for at least 10 meters;
* had no previous experience of using the Nintendo RingFit.

Exclusion Criteria:

* had a severe musculoskeletal, cardiopulmonary or neurological condition that limited their participation in the exercise program or assessment;
* had a significant visual or hearing impairment that limited their ability to follow exercise instructions;
* scored 18 or below in the Montreal Cognitive Assessment Hong Kong version (HK-MoCA) 4; or
* participated in any structured exercise program in the past 6 months.
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating

A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.

The current study will test the following null hypothesis:

There is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.

The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.

In a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.

Eligibility Criteria:
Inclusion Criteria:

Position prior to primary reduction:

* Dorsal tilt \> 25°
* Radial shortening\> 6 mm
* Radial inclination reduced by more than 15°
* Radiocarpal malalignment \> 7 mm
* Dorsal /volar metaphyseal comminution
* Volar displacement of the distal fragment(= Smith's fracture)

Position after initial reduction:

* Dorsal tilt \> 5°
* Radial shortening \> 4 mm
* Radial inclination reduced by more than 10°
* Radiocarpal malalignment \> 4 mm

Exclusion Criteria:

1. Gustilo-Anderson type III open fractures
2. Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
3. Previous distal radius fracture or other disabling injury to the contralateral side
4. Dementia or other psychiatric illness which affect compliance
5. Congenital anomaly
6. Bilateral radius fracture
7. Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities
8. Systemic joint disease such as rheumatoid arthritis
9. Patients who do not speak Norwegian
10. Pathological fracture other than osteoporotic fracture
11. Congenital bone disease (for example osteogenesis imperfecta)
12. Age below 18 and above 70
13. Patients not belonging to Akershus University Hospital
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations

The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.

Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.

Eligibility Criteria:
Inclusion Criteria:

* 26-30 gestational age
* surfactant instillation

Exclusion Criteria:

* congenital heart disease
* congenital central nervous disorder
* congenital genetic disorders
Combination Medications vs. Patch Alone for Medically-Ill Smokers

Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness

Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).

Eligibility Criteria:
Inclusion Criteria:

* currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
* 18 years or older
* interested in quitting within the next 30 days
* one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)

Exclusion Criteria:

* contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
* current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
* unable to give consent
Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety

Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.

Therefore the overall study aims are:

* To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course.
* To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis
* Patients aged 18-85 years
* Willingness to participate as demonstrated by giving a written informed consent.

Exclusion Criteria:

* Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy
* Age less than 18 years
* Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts)
* One-stage total pancreatectomy
* Missing written consent
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.

Study objectives :

* To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
* To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.

Other inclusion criteria:

* Patients between ages 30 and 80
* Hoehn and Yahr stage of PD over IIb
* Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication
* LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV
* Patient is willing to adhere to protocol requirements as evidence by written informed consent

Exclusion Criteria:

* Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.
* Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.
* Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.
* Patient has a low Mini-mental Examination MMSE score \<25 or has a history of bipolar psychosis or schizophrenia.
* Patient is unwilling to sign an informed consent or to comply with protocol requirements.
* Patient is taking or has taken in the past month amantadine.
Effect of Connective Tissue Massage on Premenstrual Syndrome

This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.

Premenstrual syndrome is a collection of emotional, physiological and behavioral symptoms that develop around the end of the luteal phase and fade away with or after mensturation.

The physiological effects of connective tissue massage (CTM) are both local and general. Local effects include release of histamine from mast cells which leads to a triple response, local swelling and arteriolar dilatation mediated by local axon reflexes. The increased blood flow to the region assists resolution of subacute or chronic inflammation and reduces pain by removing nocigenic chemicals from the tissues. The mechanical distortions produced by CTM strokes help to mobilize connective tissue and improve function.

Few studies have investigated the effect of the CTM on premenstrual syndrome in adolescent females. So this study will be conducted to add new information about the effect of connective tissue massage on premenstrual syndrome, which may help adolescent females suffering from this syndrome in decreasing their symptoms, thus adding new information to the field of physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Virgin adolescent females diagnosed with premenstrual syndrome.
* Their age will be ranged from 17-25 years (3 years post puberty).
* Their body mass index (BMI) will be less than 30 kg/m2 .
* All are of regular menstrual cycles.
* All of them suffering from moderate and severe PMS.

Exclusion Criteria:

Participants will be excluded from this study if they have

* Any pathological finding in the pelvic cavity as polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
* Irregular menstruation.
* Any history of gynecological intervention.
* Open wounds, weak/broken bones or fractures.
The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.

The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.


Eligibility Criteria:
Inclusion Criteria:

1. Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
2. Saphenous vein graft harvesting using the no-touch technique.
3. The saphenous vein anastomised to the left anterior descending artery.
4. Informed consent

Exclusion Criteria:

1. Allergy to contrast media.
2. Impaired renal function.
3. Inability to conduct the study according to protocol.