cyrilzakka/clinical-trials huggingface dataset:
Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.


Eligibility Criteria:
The inclusion criteria of children with CP are:

1. diagnosed with congenital hemiplegic
2. no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)

The exclusion criteria of children with CP are:

1. have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
2. have injections of botulinum toxin type A.

The inclusion criteria of typically developing children are:

1. absence of medical or developmental diseases which would affect physical and cognitive performances
2. having normal corrected vision
3. studying in regular education classroom in primary school for the 6-12 year-old children.

The exclusion criteria of typically developing children are:

(1) having score not within normal limits in BOTMP-short form
Gene Therapy in Treating Patients With Cancer of The Liver

Phase I trial to study the effectiveness of gene therapy with the p53 gene in treating patients who have cancer of the liver that cannot be surgically removed. Inserting the p53 gene into a person's tumor may improve the body's ability to fight liver cancer.

OBJECTIVES:

I. Determine the safety of adenovirus p53 construct (adeno-p53) in patients with hepatocellular carcinoma.

II. Investigate the potential effects of intralesional adeno-p53 given by monthly percutaneous injections in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive adenovirus p53 construct by percutaneous injection to a maximum of two lesions on day 1. Treatment is repeated every 28 days for up to 6 courses. In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of the drug on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and that dose is declared the maximum tolerated dose. Study treatment may continue in the absence of disease progression and unacceptable adverse events.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed unresectable hepatocellular carcinoma (HCC) or highly suspicious for HCC based on CT scan and elevated alfafetoprotein
* Measurable disease by abdominal CT scan Accessible (peripheral) lesions
* No metastatic disease

PATIENT CHARACTERISTICS:

* Age: Over 18
* Performance status: ECOG 0-2
* Life expectancy: At least 12 weeks
* Platelet count at least 60,000/mm3
* Absolute neutrophil count greater than 1,500/mm3
* Prothrombin time of no greater than 16 seconds after administration of fresh frozen plasma
* Bilirubin no greater than 3.0 mg/dL
* Creatinine less than 1.5 mg/dL
* Child's class A or B cirrhosis eligible
* No uncontrolled infection Not pregnant or breast feeding
* No unstable or severe intercurrent medical condition

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior radiation therapy
* No prior hepatic transplantation
* No more than 1 prior systemic regimen for hepatocellular carcinoma allowed
* No concurrent therapy with other investigational agents
* No prior gene therapy
* No prior intralesional therapy
Genetic Polymorphisms Affecting Effect of High Intensity Training

The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 30 to 60, healthy male subjects (at screening)
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below; liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
* Subject who already participated in other trials in 30 days
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
* Subject who smokes an average of 20 cigarettes/day or drink \> 5 cups of coffee
Dental Pain (Following Third Molar Tooth Extraction) Study

The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Eligibility Criteria:
Inclusion criteria:

* Scheduled for outpatient surgical removal of at least two third molar teeth.

Exclusion criteria:

* Subjects who do not achieve moderate to severe pain.
* Subjects who do not use acceptable contraception.
* Additional medical criteria will be assessed by the investigator.
Exercise and Tumor Blood Flow

This research aims at investigating tumor blood flow response to acute exercise in human cancer patients. It is hypothesized and expected that acute exercise increases tumor blood flow, which could plausibly increase the efficacy of cancer treatment.

Physical activity has been applied as an adjunctive therapy in the secondary prevention of many cancers, but very little is currently known clinically and mechanistically about the effects of physical activity and exercise on tumor itself. Based on recent evidence from pre-clinical studies, it is plausible to expect that changes in tumor blood flow and its heterogeneity, oxygenation, and metabolism due to exercise would increase the delivery of chemotherapy and other cancer drugs into the tumor increasing the efficacy of cancer treatment.

Eight (8) newly diagnosed Hodgkin lymphoma cancer patients will be recruited to investigate whether these pre-clinical findings can be extended to humans to serve as an evidence-based proof-of-concept for the possible inclusion of exercise in the treatment of cancer during chemotherapy. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, supine bicycle exercise in a positron emission tomography (PET) scanner will be used to exercise Hodgkin lymphoma cancer patients. These experiments are additional measurements to their normal treatments, and no new interventional approaches will be conducted in this study.

The study consists of one fitness test assessment, and tumor blood flow measurements with PET at rest and during supine cycling exercise.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed Hodgkin lymphoma

Exclusion Criteria:

* abnormal fatigue, anemia, or physical dysfunction due to the disease
Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)

* Prospective, multi-center, single-arm registry study
* A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled.
* All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure.
* Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years or older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4 or 5)
3. Atherosclerotic popliteal artery disease (stenosis \> 50%)
4. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Involvement of SFA disease with stenosis
4. Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
5. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Previous bypass surgery or stenting for the target popliteal artery
13. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Is Pre-anaesthetic Teleconsultation a Safe Alternative to Traditional Pre-anaesthetic Consultation?

A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.

The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.


Eligibility Criteria:
Inclusion Criteria for prospective group (AFTER):

* Patients scheduled for gastroscopy and/or colonoscopy and who have signed the consent form.
* Pre-anaesthetic consultation by telephone.
* Procedure scheduled in day hospital.

Inclusion Criteria for retroscpective group (BEFORE):

patients having undergone gastroscopy and/or colonoscopy during the period between 01/01/2023 and 31/06/2023.

* Pre-anaesthetic consultation carried out face-to-face.
* Day hospital procedure.
* Patients eligible for teleconsultation

Exclusion Criteria:

* Participation in another clinical study within the previous month.
* Patient unable to complete the questionnaire.
Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

The purpose of this research is to determine the effects of a chewing gum containing dietary nitrate to gingival and heart health. Dietary nitrates are commonly found in leafy vegetables and beets. The information learned from the study may help further understand the interconnection of oral health and heart health. The study is looking for individuals who present with mild to moderate gum irritation or bleeding.

In the study participants will be randomized into either a group that will use a chewing gum containing dietary nitrate, or use a placebo chewing gum during a three-week period.

Participants in the study will have a simple gingival exam, x-rays if needed, and small samples of saliva and blood collected. All participants will also undergo a routine tooth cleaning. Participants will be asked to breathe in a tube to sample the levels of nitric oxide. Finally, participants will have their heart health measured with a device that is like a blood pressure cuff.

The purpose of the project is to characterize, in subjects with gingival inflammation, the effect of a prebiotic dietary nitrate formulated chewing gum on the oral microbiome. In order to assess this, gingival health and parameters related to vascular health are observed:

The study is testing the hypothesize that short term use of functional gum will have improved inflammatory measures of the gingiva and beneficial cardiovascular impact. The study hopes to discover if any observed changes to oral and cardiovascular measures may be associated to changes to oral microbiome composition.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with mild to moderate gingivitis, defined with a MGI score of at least 2.0
* Subjects must have a minimum of 20 natural teeth
* Subjects must be able to chew gum

Exclusion Criteria:

* Significant alveolar bone loss (\>3.0 mm CEJ to bone)
* Requirement for antibiotic pre-medication prior to dental procedures
* Systemic antibiotic use in past 14 days to current.
* Use of anti-inflammatory (NSAIDs) or in past 14 days
* Use of anticoagulant therapy or in past 14 days.
* Current smokers
* Pregnancy
* Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder

To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).


Eligibility Criteria:
Inclusion Criteria:

* The patient has achieved either partial (some symptoms of a MDE are present but full criteria are not met) or full remission of major depressive disorder (MDD), diagnosed according to DSM-IV-TR™.
* The patient has HAMD-17 total score ≤10.
* The patient has received SSRI monotherapy for the MDE from which the patient is currently in full or partial remission for ≥12 weeks at licensed doses and been on stable dose ≥8 weeks prior to Screening Visit.
* The patient has ≥50% response to current SSRI treatment (Antidepressant Treatment Response Questionnaire \[ATRQ\]).
* The patient has a PDQ-D total score \>25.
* The patient is a man or woman, aged ≥18 and ≤65 years.

Exclusion Criteria:

* The patient has a score ≥70 on the DSST (numbers of correct symbols) at the Baseline Visit.
* The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit.
* The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
* The patient is diagnosed with reading disability (dyslexia).
* The patient has a history of lack of response to previous adequate treatment with vortioxetine.
* The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using Mini International Neuropsychiatric Interview (MINI).
* The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of the depressive episode from which the patient is currently in full or partial remission (DSM-IV-TR™ criteria).
* The patient has borderline, schizotypal, schizoid, paranoid, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
* The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria).

Other protocol-defined inclusion and exclusion criteria may apply.
Effects of a Multi-Ingredient Pre-Workout Supplement on Energy Expenditure During Running

The primary purpose of this study was to examine the acute effects of one versus two doses of a multi-ingredient pre-workout supplement on energy expenditure during moderate-intensity treadmill running. In addition, our second aim was to investigate the responses of associated metabolic factors (i.e. substrate utilization, measures of gas exchange), perceived exertion, and resting cardiovascular variables with one and two doses of the pre-workout supplement.

This study utilized a randomized, double-blind, placebo-controlled, within-subjects crossover design (Figure 1). Each subject was required to visit the laboratory on five occasions with 72-96 hours between sessions. During the first laboratory visit, each subject performed an incremental test on a treadmill to familiarize the subjects with the testing procedures. For the second laboratory visit, each subject performed an incremental treadmill test to exhaustion to determine their ventilatory threshold (VT). The third laboratory visit was completed in the morning (06:00-09:00) and required subjects to consume a standardized meal after fasting overnight (8 hours) and sat quietly for 30 minutes before baseline heart rate and blood pressure values were recorded. The subjects were then randomly assigned to ingest the supplement (one or two doses) or placebo and sit quietly for another 30 minutes. The ingredients of the supplement (Cellucor, Bryan, TX) are provided in Table 1. The placebo was non-energetic and controlled for similar appearance and taste. At the 15-minute and 30-minute post-ingestion periods (of the pre-workout supplement or placebo), resting heart rate and blood pressure were recorded for a second and third time, respectively. Subjects then performed a 30-minute constant-velocity treadmill run at 90% of their VT. The subjects then returned to the laboratory for their fourth and fifth visits to ingest the remaining substances (1-dose, 2-dose, or placebo) and undergo the same testing procedures (including time of day) as the third visit. Each subject recorded 2-day food logs (MyFitnessPal, Inc., USA) prior to each laboratory visit.

Eligibility Criteria:
Inclusion Criteria:

* ran ≥ 16 km per week

Exclusion Criteria:

* (i) history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders; (ii) use of any medication; (iii) use of nutritional supplements; (iv) habitual use of caffeine (≥ one cup of coffee or caffeinated beverage per day); or (v) participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.
Partial Rebreathing in the Treatment of Migraine With Aura

A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain


Eligibility Criteria:
Inclusion Criteria:

* - Migraine with aura
* Attack frequency of between one and six migraine-with-aura attacks per month over the last six months
* Adults (18-60 years)
* Age at onset of migraine \< 50 years
* If taking migraine prophylactic drugs, the dosis must have been stable for \> 3 months
* Must speak and understand Danish

Exclusion Criteria:

* - Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease
* Chronic migraine, i.e. more than 15 headache days per month over the last three months
* Medication overuse headache
* More than six migraine-with-aura attacks per month
* Non-migraine headache on more than six days per month
* A typical duration between migraine-with-aura attacks of less than 48 hours
Diabetes Companion App for Adults With Diabetes and Their Carers

Diabetes self-management support, education, and training are increasingly being delivered through digital technology such as mobile phones. This protocol aims to evaluate the effectiveness of GLOW, a diabetes companion app with a conversational agent.

Adopting a healthier lifestyle and disease self-management skills is critical to reducing the risk of diabetes-related complications. Internationally, and in Singapore, the majority of people with diabetes report not having received structured diabetes education, while others have the knowledge and fail to apply it in their daily lives.

Key self-management behaviours recommended by the American Association of Diabetes Educators include physical activity, healthy diet, blood glucose monitoring, and medication adherence, but equally important is healthy coping to maintain a positive attitude toward diabetes management. Life-long patient education and continuous empowerment are paramount to successful self-management in people with diabetes, as recommended by evidence-based diabetes management guidelines.

In addition to patients, their informal carers often play an important role in the management of diabetes. As such, diabetes education for informal carers is essential to achieve the best possible diabetes outcomes in the patient.

There are hundreds of diabetes apps available for the public to download and use, but few are rigorously evaluated for clinically meaningful outcomes. We designed GLOW, a diabetes companion app with a conversational agent, to support people with diabetes and their carers with self-management and knowledge.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes
2. 21 years old or above
3. Able to speak and read English
4. Singapore nationality or permanent resident or foreign domestic worker (for carers)
5. Own a personal mobile device which can download study mobile app
6. Access to the internet

Exclusion Criteria:

1. Are unable to consent;
2. Are pregnant (for patients)
3. Received formal training in medicine or allied health services