cyrilzakka/clinical-trials huggingface dataset:
Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants

Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).

The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.

Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
* at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)

Exclusion Criteria:

* Peripheral neuromotor disease e.g. brachial plexus injury
* iatrogenic restricted movements (e.g. cast for clubfoot)
Triple Combination Therapy of Choroidal Neovascularization in AMD, a Cost Effect and Efficient Therapeutic Treatment

We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.

Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.

Eligibility Criteria:
Inclusion Criteria:

- MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria:

-
Osteoporosis Prevention: Changes to Exercise and Diet in Children

The purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.

In recent years, osteoporosis has become a major public health problem in the United States. Osteoporosis can best be prevented by optimizing bone mineral gain and reducing bone loss. Because the rate of bone development reaches its peak during adolescence, fostering bone health in childhood is of critical importance. Although there have been many studies of exercise and nutritional factors that influence bone mass in adults, few randomized, prospective studies have been conducted in children. This study will determine whether parent training is effective in increasing children's calcium intake, strength, and frequency of aerobic exercise.

Families will be randomly assigned to either the physical activity and nutrition intervention group or to the injury prevention control group. Families in both groups will undergo training during 9 weekly classes. The intervention training will emphasize health topics, principles of behavior, and contingency management techniques. Post-training coaching procedures will be provided periodically for 9 months. Coaching procedures will assist parents with problem solving and help them refine and maintain parenting skills. All families will be assessed prior to training and at Months 3, 9, and 12. Outcome measures will include 24-hour recall estimates of change in diet and change in physical activity. Total bone calcium, bone density, body composition, and skeletal age will also be assessed.

Eligibility Criteria:
Inclusion Criteria

* Participates in organized sports less than 3 days a week and less than 9 months per year
* Parent willing to attend weekly training sessions

Exclusion Criteria

* Serious medical illness
* Spends less than 4 days a week with the parent willing to attend classes
* Body mass index \> 32
Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy

About 30% of breast cancers have higher than normal levels of a cellular marker called HER2. The amount of HER2 is often measured in breast tissue. A higher level of this marker usually indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker found in breast cancer cells. Detection of Circulating cytokeratin in the blood could indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through blood testing has clinical significance for patients with breast cancer.

* Single Variate analysis will be performed to correlate variables such as tumour size, grade, stage, ER status, PR status and biopsy HER2 status with soluble HER2 levels.
* Soluble HER2 levels will be analyzed as both a continuous and categorized variable.
* The analysis will attempt to discern the relationship between soluble HER2 levels, HER2 positive circulating epithelial cell level and treatment response.
* This will provide evidence of the effect various treatments have on HER2 levels. HER2 levels both in patients treated with Herceptin and those on other treatment protocols, will be related to clinical disease measures such as time to progression, time to failure, duration of response and duration of survival.
* An initial model of the relationship between these factors and soluble HER2 as a marker will be established from the data.

Eligibility Criteria:
Inclusion Criteria:

* Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.

Exclusion Criteria:

* Greater than 80 years of age
* Previous cancer diagnosis - (other than skin cancer)
Cognitive Reserve and Second Language Acquisition

Bilingualism has been shown to have a strong protective effect against dementia, delaying the diagnosis of Alzheimer's disease by up to 4 years. The purpose of the study is to test whether learning a second language using Duolingo software could improve cognitive functions in older adults.

This study is a 3-arm, randomized controlled trial. The primary objective of the study is to test the impact of second language acquisition through short-term use of the Duolingo app on cognitive functioning, particularly executive function in older adults compared to a brain training application.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have normal vision and hearing.
* Participants must be able to travel to Baycrest by personal or study-arranged automobile, or public transportation.
* Participants must be monolingual native English speakers.
* Participants must be willing to provide informed consent.
* Participants must have daily access to a smartphone/mobile device.
* Have not previously studied Spanish formally, nor any other language in the past 10 years.

Exclusion Criteria:

* have a neurological disorder.
* meet DSM-IV-TR criteria for Axis I mood, anxiety, or psychotic or substance abuse disorders.
* Fluent in more than one language.
Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment.

There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings.

We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.

Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound.

Patients will be followed for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically stress urinary incontinence
* Patients who claim that their condition severely impair their quality of life
* Patients who are failed on conservative management (life style changes and pelvic floor exercises)

Exclusion Criteria:

* Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation)
* Patients who have neurological condition that may affect the incontinence
* Patients who have psychiatric disease that may affect the subjective evaluation.
Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of dietary polyphenols (soymilk, green tea, and blueberry) in humans after a single dose of dietary flavonoids.

A crossover design was used. Sixteen healthy volunteers (16 for each study, in total 48) were recruited and asked to avoid the consumption of any soymilk, green tea, and blueberry products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.

On week 2, each of the eight participants received 460 ml of soymilk, green tea, and blueberry in a single dose, and afterward, urine and blood samples at different time points over 24 h and fecal samples at different time points over 48 h were collected. Meanwhile, the other eight participants received breakfast (without any soymilk, green tea, and blueberry) at different time points over 48 h were collected.

On the contrary, on week 3, eight participants who received regular milk or water on week 2 received breakfast only, and eight participants who were used as a control on week 2 received soymilk, green tea, and blueberry. And urine and blood samples at different time points over 24 h, and fecal samples at different time points over 48 h for both groups were collected.

Samples will be analyzed by LC-MS/MS. The Pharmacokinetics of conjugates will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 25-70 years
2. BMI between 18 and 30
3. Have no known allergy to soy milk
4. Be not taking antibiotics for six months
5. Be not currently taking medication

   1. No taking any prescription drugs
   2. If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided.

      Major brands Notes: All flavonoid-enriched supplements should be avoided. Soy Isoflavones/ tea/blueberry Lipo-Flavonoid Citrus Bioflavonoids Complex Super Flavonoids Super Antioxidants Quercetin Supplement Essential-C and flavonoids Milk Thistle Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc
   3. No any drugs or supplements within three weeks of the experiment
6. Be nonsmoking
7. Have no alcoholic intoxication

   1. No alcoholic addiction
   2. \< 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
   3. No alcohol within 3 three weeks of the experiment
8. Have no extended exposure to industrial wastes

Exclusion Criteria:

1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
2. Cancer patients

   1. Currently diagnosed cancer patients will be excluded;
   2. Medication free for \>2 years could be considered;
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient

Cancer is the second leading cause of death worldwide, with approximately 18.1 million new cases and 9.6 million deaths reported in 2018. Cancer-related pain is experienced by 50-70% of patients, with a higher prevalence at advanced disease stages (66.4%). Since the development of WHO's cancer pain guidelines, several studies have reported good relief of symptoms and suffering for a majority of patients. Recent reports suggest that up to 50% of patients still report insufficient pain control. Patients with cancer often present with multiple symptoms and functional decline. Evidence supports multidisciplinary approaches to address symptoms and suffering, including early palliative care referral

From review literatures we found that the telemedicine group had significantly higher quality of life than the usual care group. In addition, the telemedicine group had lower anxiety and depression scores than the usual care group.

Therefore, we will conduct the non-randomized controlled study of using telemedicine comparing to conventional in-person at OPD in hospitalized cancer pain patients.

The purpose of this study is to assess the pain interference by using the Brief Pain Inventory (BPI) and to compare between the in-person group and the telemedicine group. To assess the cost-effectiveness of telemedicine for reducing symptoms associated with cancer and its treatment.

The pain interference will be assessed and compared using Brief Pain Inventory from 0-70 between In-person group and telemedicine group at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years old
* Cancer patients who new visit as out patient at pain clinic, Siriraj hospital

Exclusion Criteria:

* Cannot read and write
* Confusion
* Unable to use the 0-10 Numerical Rating Scale (NRS) to rate pain intensity.
* Unstable clinical presentation
A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment


Eligibility Criteria:
Inclusion Criteria:

All subjects:

* At least 50 kg and body mass index (BMI) within 18-38 kg/m2.
* CYP2C9 wild-type (CYP2C9\*1 homozygous carriers)

Renal impairment:

- Subjects must have either mild, moderate or severe renal impairment

Exclusion Criteria:

All subjects

* Use of other investigational drugs within certain timelines
* Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
* History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR \< 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles \>100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
* Women of child-bearing potential
* History of malignancy of any organ system
* History or presence of symptomatic postural hypotension or syncope.
* Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count \< 30,000/μL at screening or baseline.
* Clinically significant infection or recent vaccination with live-attenuated vaccines.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Renal impairment:

* History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
* Any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
* Treatment with certain drugs

Healthy subjects:

* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs

This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.

The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years or older
* Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea \[RPD\] (scale 0-10) of 3 or higher)
* Severe baseline hypercarbia/hypercapnia of 50 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas

Exclusion Criteria:

* Patient has unstable cardiovascular condition
* Significant unilateral or bilateral nasal occlusion
* Vigorous physical activity should not be performed within 2 hours of testing
* Inability to provide informed consent
* Pregnancy
* Known contraindication to perform steps of the protocol
* Absence of spontaneous respiration or known contraindication to HVNI
* Inability to use nasal cannula and HVNI therapy
* Agitation or uncooperativeness
* Determined by the clinician to be sufficiently unstable or unsuitable for this study
Oral Symptom Assessment Scale (OSAS): Validity and Reliability

Oral (mouth) symptoms are very common and often bothersome in patients with cancer. The best way to assess these symptoms is using a patient-rated symptom assessment scale. A new symptom assessment scale for oral symptoms has been developed and already tested in patients. The purpose of this study is to test the scale again to make sure it is reliable and accurate.

Oral health is multifaceted and includes an individual's ability to speak, eat as well as to convey emotion without pain, embarrassment or discomfort. Oral health contributes to an individual's general well-being.

Poor oral health in patients with advanced cancer can be associated with negative impacts on an individual's quality of life in terms of psychological and emotional distress (e.g. avoiding social interactions due to embarrassment) and physical distress (e.g. pain associated with mucositis). As well as this certain problems can be associated indirectly with mortality in patients with advanced cancer e.g. oral infection leading to systemic infection.

In patients with advanced cancer oral symptoms are common, often multiple and of high-impact. Routine screening for oral symptoms should be undertaken in all patients with advanced cancer in conjunction with regular examination of the oral cavity to ensure correct diagnosis and adequate treatment.

A novel oral symptom assessment scale (OSAS) was designed and developed to measure the frequency, severity and distress (or bother) of twenty oral symptoms in patients with advanced cancer. This initial observational study provided provisional validation of the new assessment tool.

This study aims to further investigate the reliability and validity of this novel oral symptom assessment tool in patients with advanced cancer. Test-retesting will occur in patients deemed clinically stable. Test- retesting will be undertaken to measure reliability on two occasions 24-48 hours apart. Recruited patients will be asked to fill in the OSAS as well as the EORTC QLQ- C30 and EORTC QLQ-OH15 (a validated quality of life assessment with an oral health module) which will provide criterion (concurrent) validity.

Eligibility Criteria:
Inclusion Criteria

* Any cancer diagnosis
* Age ≥ 18 years old
* Able to understand and speak English
* Signed witnessed consent form
* In the 'Stable' clinical phase

Exclusion Criteria

* In the judgement of the Palliative Care physician, study participation is not appropriate
* Unable to complete the study assessments in entirety i.e. in full at Time 1 ( 0 hours) and at Time 2 (24 hours later)
* In the 'Unstable', 'Deteriorating' or 'Terminal' clinical phase
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.


Eligibility Criteria:
Inclusion Criteria:

1. female volunteers of childbearing potential;
2. are first time users of OC or have discontinued OC at least 2 months prior to study entry;
3. age between 18 and 35 years old;
4. normal body mass index (18-30);
5. has signed consent form; and
6. is in good health as confirmed by medical history, physical examination

Exclusion Criteria:

1. a positive pregnancy test will automatically exclude the volunteer from participation in this study.
2. any contraindication for oral contraception use;
3. known hypersensitivity to Letrozole and co-administered medications;
4. irregular menstrual cycles;
5. ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
6. history of pituitary tumor;
7. HIV, HBV, HCV infection;
8. vaginal infection;
9. abnormal ECG;
10. abnormal lab tests for blood profile, liver function and renal function;
11. uncontrolled diabetes and blood pressure;
12. pregnancy (suspected or diagnosed) or lactation;
13. history or suspicion of drug or alcohol abuse;
14. history of severe mental disorders;
15. participation in an investigational drug trial within the 30 days prior to selection;
16. exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:

    * history of, or actual, thrombophlebitis or thromboembolic disorders.
    * history of, or actual, cerebrovascular disorders.
    * history of, or actual, myocardial infarction or coronary artery disease.
    * acute liver disease.
    * history of, or actual, benign or malignant liver tumors.
    * history of, or suspected, carcinoma of the breast.
    * known, or suspected, estrogen-dependent neoplasia.
    * undiagnosed abnormal vaginal bleeding.
    * any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.