cyrilzakka/clinical-trials huggingface dataset:
Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes

Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.

The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group.

The hypothesis from this study are: i) the experimental group will show a significantly greater improvement in the neuropsychological tasks that measure cognitive and emotional processes compared to the active control group after the intervention; ii) the experimental group will show a significantly greater improvement in the tests evaluated by their parents after the intervention compared to the active control group. All hypotheses will be controlled for age and socioeconomic status.

Eligibility Criteria:
Inclusion Criteria:

* To be enrolled in an ordinary educational center.
* To provide informed consent from both parents and the participant's agreement to participate in the study.

Exclusion Criteria:

• Sensory/comprehension difficulties that make it impossible to carry out the program activities.
Clopidogrel Resistance and the Possibility of Its Affection

The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.

Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test. We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder. Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* coronary artery disease verified by coronary angiography
* percutaneous coronary intervention with stent implantation
* standard indication for dual antiplatelet therapy

Exclusion Criteria:

* scheduled surgical revascularization by aortocoronary bypass
* insufficient cooperation of the patient
* coagulopathy in history with a higher risk of bleeding
* life expectancy shorter than 1 year
* severe anemia with hemoglobin level\< 10,0 g/dl
* platelet count \< 100,000)
The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia

Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia. In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.

Even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (CAM) specialists for help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is commonly used to treat insomnia in the field of CAM. Among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear acupressure on insomnia.

Insomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear acupuncture and its related techniques are believed to act through the reticular formation and the ANS may thus result in an amelioration of illness.

In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of primary insomnia

Exclusion Criteria:

* diabetic neuropathy
* cardiac arrythmia
* liver disease (ALT\> 120 U/L)
* renal disease (Cr\> 2 mg/dl)
* severe depression
Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)

This study is a retrospective chart review of patients treated with onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Patient with documented idiopathic OAB diagnosis
* Patient was treated with 100-200U of BOTOX® for OAB
* Urodynamics assessment within prior to first BOTOX® injection.

Exclusion Criteria:

* Patient had received botulinum toxin formulations other than BOTOX® in the bladder
* Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent by patient or legally acceptable representative
* Meets the criteria in the approved regulatory indication for first line treatment with osimertinib and agree to the restrictions, monitoring, and dose-adjustment criteria stipulated in the associated product label
* Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
* No prior systemic therapy except neoadjuvant, adjuvant or concurrent chemotherapy given greater than 3 months prior to enrollment on study
* Asymptomatic or minimally symptomatic brain metastases (ie. Headache, nausea, or seizure responsive to dexamethasone/analgesic/antiepileptic on stable doses of medications for a minimum of 3 days)
* Brain metastases must meet the following criteria on a diagnostic MRI: at least one lesion can be classified as measurable disease per RANO-BM, ≤ 10 brain or brainstem metastases, ≤ 30 mm and brainstem metastases must be ≤ 5 mm, metastases \> 5 mm from the optic nerve or chiasm
* ECOG performance status 0-2
* Life expectancy \> 6 months
* Willing to abstain from sexual activity or willing to use double-barrier method during sexual intercourse

Exclusion Criteria:

* Previous treatment with osimertinib, or any other EGFR TKI
* Patient with symptomatic brain metastases causing any neurologic deficit (not including headache, nausea, or medically controlled seizure)
* Multiple sclerosis
* Pacemaker or MRI-incompatible metal in the body
* Allergy to gadolinium MRI contrast
* Brain metastasis requiring surgery for decompression
* Leptomeningeal disease
* Previous cranial RT, or surgery for brain metastases
* Uncontrolled systemic lupus erythematosis, scleroderma or other connective tissue disorders considered a contraindication for radiotherapy
* Active cancer from another anatomical site within 5 years (non-melanomatous skin and cervical cancers permitted)
* Any medical or non-medical issue that would render patient unable to reliably complete regular QOL and neurocognitive assessments
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
* Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
* Patients with symptomatic CNS metastases who are neurologically unstable
* Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
* Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib
* Pregnant or breastfeeding
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia

The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily provided a written consent to participate in this clinical study
2. Male or female adults aged 19-70 years
3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
4. Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP \< 180 mmHg) at the pre- baseline visit (V2) after wash-out period
5. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Exclusion Criteria:

1. Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
2. Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1)
3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c \>9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2))
5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
9. Pregnant or lactating women
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.


Eligibility Criteria:
Inclusion Criteria:

* must be diagnosed as having active rheumatoid arthritis
* agree to participate in the study and sign and informed consent document

Exclusion Criteria:

* History of serious infection within the past 6 months
* test positive for TB
* have any uncontrolled clinically significant disease or laboratory tests
* require administration of prohibited medications during the study
A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors

HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors.

This is a Phase 1 open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary efficacy of HS-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged more than or equal to (≥) 18 years
2. Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
5. Estimated life expectancy greater than (\>) 12 weeks
6. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
7. Sign Informed Consent Form

Exclusion Criteria:

1. Treatment with any of the following:

   1. Previous or current treatment with drugs targeting SHP2
   2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
   3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
   4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
   5. Known and untreated, or active central nervous system metastases.
2. Existing abnormal CTCAE≥grade 2 resulted from previous treatment
3. History of other malignancy
4. Inadequate bone marrow reserve or organ function
5. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
6. History of hypersensitivity to any active or inactive ingredient of HS-10381.
7. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
8. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
* Written informed consent obtained from parents/legal guardian of the subject
* Free of obvious health problems as established by medical history and/or clinical examination before entering the study
* Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits

Exclusion Criteria:

* Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
* Planned administration of a vaccine not foreseen by the study protocol
* Known or suspected impairment of immune function, known Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)
* Administration of parenteral immunoglobulin preparation and/or blood products since birth
* Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)
* History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate
* Significant acute infection
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
* Participation in another clinical study
Burden and Outcome of Shoulder Disorders in Primary Health Care

Consumption of medical care and outcome of shoulder pain and disability in primary care.

Shoulder pain and impairment are common in primary health care. The prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. The objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care.

A composite questionnaire consisting of demographic information and ASES questionnaire was used to measure the shoulder function. The patients were sent a second questionnaire after one year.

Eligibility Criteria:
Inclusion Criteria:

* All individuals suffering from shoulder pain or impairment

Exclusion Criteria:

* No
Cranberry Juice for Treatment of Urinary Tract Infections

The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.

Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Culture-confirmed urinary tract infection at study start

Exclusion Criteria:

* Other chronic disease
* Antibiotics within 48 hours prior to study start
* Hospitalization for any reason within 2 weeks prior to study start
* Stones in urinary tract
* Plans to leave Ann Arbor within 6 months after study start
* Allergy to cranberry or cranberry compounds
* Pregnancy
Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD

ADPKD is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the U.S. ADPKD consists of 2.8% of patients receiving kidney transplantation in our center. It is known that ADPKD is associated with vascular anomalies, including abdominal aneurysms, valvular anomalies and especially intracranial aneurysms. Intracranial aneurysms occur in 9\~12% of the ADPKD population which is higher than 2\~3% in the general population and is known to be associated with PKD1 or PKD2 heritage.

Until now, most of the studies regarding intracranial aneurysms in ADPKD are conducted in animal models, and there are only few cellular studies conducted from human samples. While performing kidney transplantation to ESRD ADPKD patients, arterial tissues from nephrectomy specimens can be obtained. The objective of this study is to investigate the mechanism of intracranial aneurysm in ADPKD patients by analyzing iliac and renal artery characteristics.

ADPKD is associated with PKD1 gene on chromosome 16 and PKD2 gene on chromosome 4 and these gene respectively code polycystin 1 and polycystin 2. Currently the hypotheses for increased intracranial aneurysm rate in ADPKD patients is that mutation of polycystin is not only confined to nephron tissues but also in endothelial cells and vascular smooth muscle cells and results in mutation of vascular phenotype. Also recent studies show polycystin complex causes cystic changes through mutation in primary cilia in renal epithelium. Wild type endothelial cells respond to fluid shear stress by regulating levels of intracellular calcium and nitric oxide, however, PKD1 or PKD2 mutation in fetal aortic endothelial cells revealed loss of these responses.

During kidney transplantation, bilateral nephrectomies are routinely performed to ADPKD patients. In this study, blood, urine, iliac artery and renal artery tissues will be collected from ADPKD patients receiving kidney transplantation to analyze the arterial characteristic and gene mutation of ADPKD patients. The aim of this study is to evaluate mechanisms associated with intracranial aneurysm occurence in ADPKD patients by analyzing the genetic mutation and vascular deformities of these patients.

Eligibility Criteria:
Inclusion Criteria:

* ADPKD patients from ages 18 to 80 receiving kidney transplantation at Asan Medical Center

Exclusion Criteria:

* those who refuse or are unable to provide consent form
* pregnancy