cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Oculomotor Training in Parkinson's Disease

Parkinson's disease (PD) is a common neurodegenerative disorder which is characterized by both motor and non-motor symptoms and usually affects people aged 50 years or above. Many studies showed eye movement deficits and visual changes in patients with PD.

Previous studies have also indicated that clinical eye movement training could enhance the functional performance of patients with various eye movement problems resulting from ocular and neurodegenerative diseases.

In this study, we will investigate the effectiveness of eye movement training on dynamic vision and functional performance in PD patients with oculomotor deficits.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage

  1 to 4 (Hoehn and Yahr Classification)
* Able to speak and comprehend Cantonese dialect
* Able to travel independently

Exclusion Criteria:

* Any congenital eye problem (e.g. congenital strabismus or amblyopia in either eye) or any manifest eye diseases (e.g. macular degeneration, glaucoma, etc)
* Severe medical problems (e.g. stroke)
* Cognitive impairment (e.g. dementia)
* Presence of any psychiatric or neurological diseases (apart from Parkinson's disease) or receiving of any psychoactive pharmacological treatment
* Receiving any medication that is known to affect eye movement and cognitive function
* Previous formal vision rehabilitation or oculomotor intervention
A Lifestyle Change Program to Prevent Type 2 Diabetes

The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.


Eligibility Criteria:
Inclusion Criteria

* age 21 or older
* medically stable and safe to exercise
* at high risk for type 2 diabetes
* able to speak English.

Exclusion Criteria

* Type 2 diabetes
* Cardiovascular disease
* Cancer requiring treatment in the past 5 years
* Anemia
* Hepatitis
* Renal disease
* Gastrointestinal disease
* Recent or significant abdominal surgery
* Pulmonary disease with dependence on oxygen or daily use of bronchodilators
* Chronic infection (ie., HIV, active tuberculosis)
* Unable to walk 0.25 miles in 10 minutes
* Participation in commercial diet program
* Currently pregnant or within 3 months postpartum
* Currently nursing or within 6 weeks of having completed nursing
* Treatment of impaired glucose tolerance (IGT) with metformin
* Currently taking any glucocorticoid or beta-blocker
* Recently prescribed or changed dose of a statin (within 2 months)
Predictive Role and HuR Mechanisms of Regulation in the Brain Tumours

The HuR protein binds to AU-rich elements in the untranslated 3' region of messenger RNA, thus allowing their stabilization. Its targets include multiple cell cycle regulating proteins, cytokines and growth factors. In some cancers, its overall expression level but especially its cytoplasmic expression are correlated to a higher grade and constitute a poor prognostic factor. To date, HuR's deregulation mechanisms remain poorly understood. A few experimental studies have shown the role of certain microARNS, or of post-translational modifications. In brain tumours, HuR expression, its prognostic value and its deregulation mechanisms have been little studied to date.

The first part of the project will be a monocentric retrospective study of human brain tumour samples collected during biopsies or surgical removal. We will first evaluate HuR expression in 140 brain tumors, including 40 meningiomas and 100 gliomas of increasing grade, and look for a correlation with histological grade and survival. We will then apprehend the consequences of its deregulation by analyzing different factors involved in the cell cycle and stress response markers. Finally, we will study the mechanisms of HuR deregulation by analyzing the expression level of several microRNAs (miR16, miR519) and the methylation state of HuR.

The second part of the project will focus on cell lines from human brain tumours. We will first attempt to confirm the interactions between HuR and markers involved in the cell cycle and stress response, then the regulation of HuR by its methylation and by microRNAs (miR16 and miR519). We would also like to study the consequences of HuR inhibition and overexpression on cell proliferation, under various conditions of induced stress (pharmacological agents, physical stress). Finally, we will study the consequences of an experimental vitamin B12 deficiency on HuR expression and tumor cell adaptation to stress.


Eligibility Criteria:
Inclusion Criteria

* Grade I and II meningiomas (WHO)
* Diffuse grade II glioma (astrocytoma, oligodendroglioma)
* Grade III anaplastic gliomas (astrocytomas and anaplastic oligodendrogliomas)
* Grade IV glioblastoma
The Effect of Art Therapy on Patients With Stroke

Stroke can affect the physical, emotional and social aspects of the patient and their family members. It is the main cause of complex disability, with a high number of people living with its effects. Stroke can result in impairments in motor function, language, cognition, sensory processing, cognition, and emotional disturbances, which can affect the performance of functional activities and mental health status. Getting patients involved in art therapy (AT) class has shown to alleviate stress and promote a sense of wellbeing, which can aid their recovery and rehabilitation. The benefits of art therapy for people living with different health conditions worldwide have been reported, however, its effect on Egyptian patients with stroke has been neglected.

Art therapy refers to a group of techniques including painting, drawing and listening to music. The participants will receive the program on three steps (early step, middle step, and late step). These steps aim to train the participants on the AT from simple to complex and motivate them to engage in the AT program.Therefore, this study aims to investigate the effect of art therapy on cognitive ability, arm activity and mental health status of patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* able to sit upright, supported or unsupported,
* oriented to time and place by using the adapted Arabic Memory Screening Test,
* able to perform at least two of the following skills: drinking from a cup, eating with a spoon and taking money from a purse by the affected arm, and
* will stay in the stroke unit to at least 4 days (for receiving three sessions out of all sessions) before discharge,

Exclusion Criteria:

* diagnosis of transient ischemic attack or brain stem stroke;
* unconscious;
* unable to provide informed consent;
* hemodynamical unstable medical conditions, including fever;
* serious infectious diseases, for example, viral hepatitis or HIV; and/or
* severe dementia or uncontrolled psychiatric problems.
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis

The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol

Key Exclusion Criteria:

* Previously documented problems with male reproductive health
* Prior diagnosis of male infertility
* Use of any prohibited concomitant medication as outlined by protocol

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds

This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds.

Participants will have their heart sounds recorded during their regular clinic appointment after consenting to participate in this study.

Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥22 years (adult)
* Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment

Exclusion Criterion:

* Implanted active medical devices in the torso, such as pacemakers and defibrillators
Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

To explore biomarkers predictive of clinical response to sorafenib in unresectable hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells.

To identify negative predictive markers to sorafenib. To elucidate signal transduction pathway attributable to sorafenib resistance. To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.

To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to sorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein \> 400ng/mL and liver cirrhosis
* Inoperable disease as defined by (Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR Presence of extra-hepatic disease OR Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR The HCC must not be amenable to intra-arterial therapy or local ablative therapy)
* Minimum life expectancy of 12 weeks
* Age \> 18 years.
* ECOG Performance Status of ≤ 2
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

(Hemoglobin \> 9.0 g/dl,Absolute neutrophil count\>1,500/mm3, Platelet count\>75,000/μl,Total bilirubin \< 1.5 times the upper limit of normal,ALT and AST \< 5 x upper limit of normal,Albumin ≥ 3g/dL,PT-INR/PTT \< 1.5 x upper limit of normal,Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥ 50mL/min)

* Signed and dated informed consent before the start of specific protocol procedures.
* FNA will be performed in patients with feasible biopsy site

Exclusion Criteria:

* Decompensated cirrhosis or stage C (Index \> 10) according to the Child-Pugh Classification
* Other concomitant anticancer agent, including Tamoxifen and Interferon
* Active clinically serious infections (\> grade 2 CTCAE version 3.0)
* History of organ allograft
* Patients with evidence or history of bleeding diasthesis
* Patients undergoing renal dialysis
* Radiotherapy during study or within 4 weeks of start of study drug.
* Prior exposure to the study drug.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization

The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.

Shexiang baoxin pill(SBP) is applicable to "Qi deficiency and blood stasis syndrome" in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion Criteria:

* Patients with severe valvular disease, congenital cardiomyopathy decompensation
* Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
* Patients that use high-dose steroids due to connective tissue disease
* Patients with serious infections
* Patients with malignant tumor
* Patients with hematopoietic diseases
* Pregnant or lactating women.
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.

Methods: it was a study achieved with 101 pregnant women with indication to induced delivery labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the blood loss at delivery. Patients were submitted to transabdominal obstetric ultrasound and basal cardiotocography. Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six. The control group was formed by 30 patients that began an spontaneously labor and 30 patients that achieved caesarians electively. The study of hemoglobin before and after delivery was evaluated through ANOVA to repeated measures, where it was verified the time effect (pre and post delivery) and the effect of the group (with and without use of misoprostol).

Eligibility Criteria:
Inclusion Criteria:

* Indication of early elective delivery by induction of labor (pre-eclampsia, HELLP syndrome, chronic hypertension, prolonged gestation, diabetes mellitus, gestational diabetes, heart disease, thyroid disease;
* pregnancy with living fetus;
* vertex cephalic presentation;
* estimated fetal weight by ultrasound \> 2500g and \<4000g;
* Amniotic fluid index (AFI)\> 5 cm, except in cases of premature rupture of membranes in which AFI \<5 cm would be allowed;
* cardiotocography (CTG) antepartum normal;
* Bishop Score less than or equal to 6;
* Determination of hemoglobin pre and post-partum.

Exclusion Criteria:

* Prior Cesarean section;
* previous uterine scar by myomectomy;
* Fetal presentation anomalous;
* Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
* Fetal growth restriction;
* Gestation multiple;
* genital bleeding;
* tumors, malformations and / or ulceration in the region vulvoperineal and birth canal;
* No determination of hemoglobin pre-and post-partum;
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis

This study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.

This study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.

Patients hospitalized for a diagnosis of babesiosis, who have received A/A for \<48 hours (h) prior to randomization or are about to receive A/A, will be asked to provide written informed consent and will undergo eligibility screening including medical history, physical examination, prior and concomitant medications, blood chemistry and hematology, glucose-6-phosphate dehydrogenase (G6PD) deficiency testing, blood smear for diagnostic confirmation of babesiosis, pregnancy testing for females of child-bearing potential, and assessment of risk factors for relapsing babesiosis. The screening period will last a maximum of two days. The first day of dosing with TQ or placebo will be Day 1 and will be done while the patient is still hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years.
* Laboratory confirmed infection with Babesia.
* Exhibiting at least one self-reported clinical symptoms of babesiosis.
* Able and willing to give written informed consent.
* Expected to be hospitalized at the time of or following informed consent and still hospitalized on the day of randomization and start of investigational products.
* Willing to complete the study activities and assessments.
* Must agree not to enroll in another study of an investigational agent prior to completion of the study.
* Able to take oral medications.
* If female of reproductive age, must agree to use an acceptable method of birth control.
* Adequate venous access.
* Blood hemoglobin ≥ 7 g/dL.

Exclusion Criteria:

* Have any contraindications to TQ.
* Have any contraindication for azithromycin or atovaquone.
* Any concomitant significant illness unrelated to babesiosis.
* Receipt of any experimental treatment for babesiosis.
* Taking any excluded concomitant medication.
* Current or planned treatment with quinine while participating in the study.
* Positive pregnancy test.
* If A/A was initiated more than 48h prior to randomization and parasitemia is not \>1%.
* Azithromycin or atovaquone administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease.
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)

The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS).

The secondary objective is to evaluate the pharmacokinectic (PK) of BIIB078 in participants with C9ORF72-ALS.

This study is an extension study of NCT03626012.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants must have completed study NCT03626012 through the first follow-up clinic visit that follows the final dosing visit without missing more than 1 dose of study treatment.
* Participants taking concomitant riluzole at study entry must be on a stable dose for ≥30 days prior to the first dose of study treatment (Day 1). Participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study.
* Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.

Key Exclusion Criteria:

* History of drug abuse or alcoholism ≤6 months before study enrollment that would limit participation in the study, as determined by the Investigator.
* Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter.
* History of or positive test result at Screening for human immunodeficiency virus. The requirement for testing at Screening may be omitted if it is not permitted by local regulations.
* Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs) or biological agent within 1 month of Screening or 5 half-lives of study agent, whichever is longer.

Note: Other protocol-specific inclusion/exclusion criteria may apply.
The Absorption of Vitamin B12 Among Healthy Pregnant Women

During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.

In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb.

.


Eligibility Criteria:
Inclusion Criteria:

* the 13 week of gestation +/- 1 week (only fore pregnant women)
* Between 20- 40 years
* Northern European
* abel to read and understand danish

Exclusion Criteria:

* treatment with vitamin B12 within the last 5 years
* daily intake of vitamins that contain more than 1µg vitamin B12
* infectious disease
* systemic disease
* daily use of medicine that interferes with vitamin B12
Evaluation of Fapi-pet in Prostate Cancer.

The investigators explore the biodistribution of FAPI-PET expression in primary high-risk prostate cancer in men undergoing RALP and eLND and in men with metastatic PCa about to start next generation antiandrogen.

This is an exploratory cohort study comprised of men with clinically localized or locally advanced high-risk prostate cancer (GG 3-5, cT2-cT3, Nx, M0) managed by RALP and eLND and men with metastatic (mHSPC or mCRPC) prostate cancer scheduled to start NHT along clinical care pathway (e.g., apalutamide, enzalutamide) at HUS Helsinki University Hospital and Helsinki University, Finland.

Men identified along routine clinical care as candidates for the study will be asked to consent.

Once consented, patients will undergo PSMA-PET imaging instead of conventional imaging (CT and bone scan) and experimental FAPI-PET imaging. Furthermore, biomarker samples will be obtained before and after treatment (surgery or novel antiandrogen) and surgical specimen will be processed for routine pathological evaluation and multiplex IHC studies. Serum samples will be tested for PCa biomarkers (e.g., PSA, NSE, CgA) and cfDNA. Urine will be processed and extracellular vesicles (exosomes) isolated and markers of reactive stroma will be sought for.

Radical prostatectomy and novel hormonal treatment will be done according to current recommendations and guidelines in Finland.

Postoperatively, patients will be followed with PSA every six months. Biochemical recurrence will be set at PSA of 0.2 ug/l or higher.

Eligibility Criteria:
Inclusion Criteria:

Men scheduled for radical prostatectomy

* Age over 18 years
* GG 3-5, cT2-cT3, Nx, M0 prostate cancer
* no contraindication to PSMA - or FAPI-PET
* willing to undergo study related procedures (imaging and laboratory tests) Men scheduled for novel antiandrogen
* Age over 18 years
* GG2-5, cT2-4, N0-1, M1
* hormone sensitive or castration resistant prostate cancer

Exclusion Criteria:

* Not willing or capable to undergo study related procedures