cyrilzakka/clinical-trials huggingface dataset:
The Effects of Action Observation and Motor Imagery on Students' Ability to Locate Anatomical Locations: A Randomised Control Trial

The aim of this investigation is to measure if additional pedagogical techniques (Action Observation and Motor Imagery) improve student's ability to identify anatomical structures compared to traditional teaching techniques.

The aim of this investigation is to measure if additional pedagogical techniques (Action Observation and Motor Imagery) improve student's ability to identify anatomical structures compared to traditional teaching techniques. Action observation is defined as watching human movement either via a pre-recorded video or a live demonstration. Motor imagery is defined as the mental representation of human movement, including its sensory and motor aspects, without physically executing the action. For example, imagining the feeling and effort of moving your upper-limb to reach out and grasp a glass of water from on top of a table. Motor imagery practice is defined as the structured engagement in motor imagery over time for the purpose of acquiring and enhancing motor skills.

Traditional teaching of anatomy using a common powerpoint based method, will be compared to the traditional powerpoint method plus the addition of action observation techniques or action observation and motor imagery techniques. The investigation, will also look at whether these interventions have an effect on information retention, by retesting the groups at a later date.

Eligibility Criteria:
Inclusion Criteria:

* Level 4 (year one) pre-registration Teesside University physiotherapy/Occupational Therapy/Radiography/Sports Rehab students.
* No previous specific University anatomy training.
* Willing to provide informed consent.

Exclusion Criteria:

* Non Teesside University students
* Healthcare students with previous University level anatomy knowledge (including those with past healthcare degrees).
* Not willing to provide consent.
A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.

The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.

This study is seeking participants who:

* have lung cancer that has reached at least the brain.
* have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have not received any treatment before.

All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* confirmed diagnosis of EGFR mutation-positive NSCLC
* at least one measurable intracranial metastasis
* ECOG-PS of 0, 1 or 2
* dacomitinib as first-line treatment for advanced NSCLC
* Evidence of a personally signed and dated informed consent document (ICD)

Exclusion Criteria:

* any anti-cancer systemic treatment within 12 months prior to index date
* currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.
Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.

This study includes Phase Ia and Phase Ib.

In the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy.

In Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* main inclusion:

  1. Evidence of a personally signed informed consent document;
  2. Male and/or female subjects above the ages of 18 years;
  3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
  4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
  5. ECOG performance score 0-1;
  6. Life expectancy ≥ 12 weeks;
  7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1

Exclusion Criteria:

* main criteria:

  1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
  2. Prior or concomitant other malignant tumor;
FREEZE Cohort Study

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm.

Eligibility Criteria:
Inclusion Criteria:

* Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting \< 1 year)
* First ablation of AF
* Age ≥18 years
* Documented inefficacy of at least 1 AAD not including β-blockers
* Written informed consent

Exclusion Criteria:

* Longstanding persistent AF lasting \> 1 year
* Acute coronary syndrome (ACS)
* Heart failure NYHA IV
* Thrombocytosis, thrombocytopenia
* Any condition contraindicating chronic anticoagulation
* Stroke or TIA within 6 months prior to ablation
* Uncontrolled hyperthyroidism
* Pregnancy
* Life expectancy \< 1 year
Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. The origin of Crohn's disease remains unknown and there is no curative therapy, either medical or surgical, for this gut disorder.

It is believed that an infectious agent is important in the development of Crohn's disease. The similarity of Crohn's disease to the animal form of ileitis, termed Johne's disease, supports the possibility that both disorders are caused by exposure to Mycobacterium avium paratuberculosis or MAP. Multiple investigators have demonstrated good clinical responses of patients with Crohn's disease to treatment with triple antibiotic therapy directed against mycobacterial infection.

The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical therapy for patients with Crohn's disease. The aim of this study is to examine the response of patients with Crohn's disease who are not receiving therapy with biological agents to triple antibiotic therapy.

Clinical remission will be determined by a decline in the Crohns disease activity index to \<151; clinical improvement will be examined using the inflammatory bowel disease (IBD) quality of life questionnaire; and endoscopic improvement will be examined using a Crohn's disease endoscopic activity index. All individuals must have had colonoscopy within 3 months of enrollment. An estimated 20 individuals will be enrolled in this protocol. Each patient will be treated for 6 months with a combination of rifabutin, clarithromycin, and clofazimine. At the end of 6 months of treatment for each patient, the Crohns disease activity index will be recalculated, each patient will again complete the IBD quality of life questionnaire, and each patient will undergo repeat colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* This study will only include patients capable of providing informed consent, ages 18 and older.
* Patients must have a documented diagnosis of Crohn's disease and have had a colonoscopy with photographs within 3 months prior to randomization.
* All patients must have a CDAI of 220 or greater at enrollment.
* All females must be post-menopausal, surgically sterilized, or either abstain from sexual intercourse or use a non-hormonal method of birth control other than or in addition to oral contraceptive during the study and for 6 weeks after the end of the study.

Exclusion Criteria:

* Any patient with ulcerative colitis
* All women of child-bearing age must have a negative urine pregnancy test within 1 week prior to the initial clinic visit.
* Patients receiving a biological therapy for Crohn's disease including remicade
* Patients with a known allergy to any of the three antibiotics used in this protocol.
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria

This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal to 450 micromole per liter.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent (for children under 18 years old the parent\[s\]/guardians give informed consent, subjects 14-17 years old give additionally their own written informed consent)
* Age of 4 - 18 years, inclusive
* Confirmed clinical and biochemical hyperphenylalaninemia due to phenylketonuria documented by past medical history with at least 2 blood phenylalanine level greater than or equal to 400 micromole per liter obtained in 2 separate occasions
* Blood phenylalanine level at screening greater than or equal to 450 micromole per liter (mean of two measurements)
* For women of childbearing potential, a negative urine pregnancy test is required at screening and willingness to use a highly effective method of contraception is required while participating in the study
* Subject and/or the parent/guardian willing and able to comply with study procedures
* Subject and/or the parent/guardian willing to continue current diet unchanged during the 8 days response test and to adapt the diet according to phenylalanine therapeutic target range during the 6 week treatment period

Exclusion Criteria:

* Subject already assessed for responsiveness to sapropterin dihydrochloride or other tetrahydrobiopterin (BH4)
* Used any investigational agent other than Kuvan® (sapropterin dihydrochloride) within 30 days of screening, or required any investigational agent or vaccine prior to completion of all scheduled study assessments
* Pregnant or breastfeeding, or considering pregnancy
* Concurrent disease or conditions that would interfere with study participation or safety (for example, seizure disorder, asthma or other condition requiring oral or parenteral corticosteroid administration, insulin-dependent diabetes, or organ transplantation recipient)
* Concurrent use of required concomitant treatment with any drug known to inhibit folate synthesis (for example, methotrexate), levodopa, phosphodiesterase type-5 (PDE-5) inhibitors (such as, sildenafil, vardenafil or tadalafil), medications that are known to affect nitric oxide synthesis metabolism or action
* Any conditions, that, in the view of the Principal Investigator renders the subject at high risk for failure to comply with treatment or to complete the study
* Clinical diagnosis of primary BH4 deficiency
* Known hypersensitivity to Kuvan® (sapropterin dihydrochloride) or its excipients or to other approved or non-approved formulation of tetrabiopterin
Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS

The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct current stimulation.

Fibromyalgia syndrome occurs in around 2% of the population (predominantly women), and is characterized by its poor response to conventional therapies. Therapeutic approaches modulating inhibitory pathways, including pharmacologic options as pregabalin, and non pharmacological ones as transcranial direct current stimulation (tDCS) have been proven to be of limited utility independently. Aiming to evaluate a better understanding of the pathophysiogenic mechanisms and the effect of these treatments on neuroplasticity, this study was designed evaluating neurophysiologic, neurochemical and clinical parameters. Neurophysiologic parameters and functions to be assessed will include pain threshold, motor evoked potential, silent period, intracortical facilitation and inhibition assessed by Transcranial Magnetic Stimulation (TMS) and optic functional neuroimaging. Neurochemical measurements considered will be neurotrophins (BDNF) and inflammatory mediators (TNF, IL1, IL6, IL10 and cortisol). Clinical characteristics will be assessed using validated scales capable to detect functional capacity, quality of life (WHOCOHL), catastrophism, sleep disruptions (Pittsburgh) and depressive symptoms (Beck Depression Inventory). Considering the above described hypothesis, the present randomized clinical trial with blinded patients and evaluators is proposed. It pretends to analyze short-, mid- and long-term neurobiological mechanisms triggered by the selected interventions.

Eligibility Criteria:
Inclusion Criteria:

* - Diagnosis of fibromyalgia according to the American College of Rheumatology criteria

Exclusion Criteria:

* Psychiatric or neurologic disorder that unable patient to consent and follow study protocol.
* De-compensated systemic disease.
* Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis).
Inflammatory Bowel Disease and Thromboembolic Events

The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017.

Exclusion Criteria:

* Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.


Eligibility Criteria:
Note: This study has two steps. In the first step, patients who meet the criteria for candidates will receive standard first-line chemotherapy for pancreatic cancer. Response Evaluation Criteria in Solid Tumors (RECIST) criteria was employed to measure tumor's response to chemotherapy every two cycles. Until some of them meet the criteria for intervention, they will be randomized and receive relevant interventions.

Inclusion Criteria for candidates:

1. Voluntary participation
2. 18-75 years old
3. Eastern Cooperative Oncology Group (ECOG) 0-1
4. Stage IV pancreatic cancer with no more than 3 liver metastases
5. Histologically confirmed diagnosis of pancreatic cancer
6. No contraindication of chemotherapy

Exclusion Criteria for candidates:

1. Not want to receive chemotherapy or potential operation.
2. Metastases at other sites except for liver
3. With other malignancies
4. Receive chemotherapy, radiotherapy, and interventional therapy before
5. Contraindication of potential operation

Inclusion Criteria for intervention:

1. Primary tumor and liver metastatic sites are both resectable.
2. No new metastatic sites were observed
3. Abnormal serum tumor maker levels decreased by more than 50% after chemotherapy. In the serum tumor makers, carbohydrate antigen 19-9 (CA19-9) was always the first choice for evaluation and it should be below 500U/L after treatment. However, when the baseline CA19-9 was within the normal range, carbohydrate antigen 125 (CA125) and carcinoembryonic antigen (CEA) were the alternative candidate indicators.

Exclusion Criteria for intervention:

1. Contraindication of operation
Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer

This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of CDK4/6 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age≥18 years, ≤75, female; 2.Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients \[HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥10%\]; 3.Prior CDK4/6 inhibitor progression or intolerance to CDK4/6i before enrollment; 4.Premenopausal patients need OFS; 5.Recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy; 6.ECOG performance status ≤ 1; 7.At least one measurable disease based on RECIST v1.1 8.Adequate organ function; 9.Life expectancy is more than 3 months; 10.Willing and able to provide written informed consent

Exclusion Criteria:

* 1.Prior exposed to histone deacetylase inhibitors; 2.Received TKI before enrollment; 3.Exist visceral crisis; 4.Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs; 5.Poorly controlled diabetes (FBG\>10mmol/L); 6.Poorly controlled hypertension (SBP\>150 mmHg, DBP\>90 mmHg); 7.Urinalysis shows urine protein ≥ 2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 8.PT\>16s, APTT\> 43s, TT\>21s, FIB\<2g/L; 9.Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled); 10.Pregnant or lactating female. 11.Any other conditions deemed inappropriate by the investigator to participate in this study.
Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events

Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.

Hypothesis/Objective :

To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention.

Method:

The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study.

Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting.

* No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination.
* Experimental: free feeding and drinking until the procedure.

Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia).

Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years undergoing elective coronary angiography or angioplasty procedures
* Agreement to participate and signed informed consent after information
* Affiliation to Social Security System

Exclusion Criteria:

* Patient requiring fasting for another procedure
* Immediate coronary emergency (STEMI, very high risk NSTEMI)
* Patient under artificial nutrition
* Hemodynamic instability
* Patient under guardianship or curators
* Pregnant women, breast-feeding
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in study 971-ONC-0028-080.

Exclusion Criteria:

* Subjects who had not previously participated in study 971-ONC-0028-080.