cyrilzakka/clinical-trials huggingface dataset:
Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

to examine the relationship between repeated concussions and late decline of brain function. In addition, all participants agreeing to participate in the study will be asked to will their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western Hospital with the consent and full knowledge of their families and doctors. However, it is possible to participate in the research without agreeing to a brain donation.

The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to determine the exact mechanism of the damage to brain tissue following repeated concussions. This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal protein in the brain called tau-protein.

We hypothesize that repeated concussions in retired professional athletes will be associated with abnormalities in neurological, neuropsychological, biofluids and neuroimaging assessments. The primary objectives of the study are:

1. To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.
2. To determine the relationship between repeated concussions and neuroanatomical abnormalities in brain gray and white matter subserving cognitive and motor functions using structural MRI assessment.
3. To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.
4. To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.
5. In order to investigate whether the effects of repeated concussions on brain function and brain structure are progressive and related to the condition known as Chronic Traumatic Encephalopathy, prospective, longitudinal, follow-up data will be collected

Eligibility Criteria:
Inclusion Criteria:

fluent in English, and a history of multiple concussions , low exposures , or no concussions (Control group ). Determination of concussion exposure will be determined as follows: Previous concussion will be based on the player's recall of injury and defined as "an injury resulting from a blow to the head that caused an alteration in mental status and one or more of the following symptoms: headache, nausea, vomiting, dizziness/balance problems, fatigue, trouble sleeping, drowsiness, sensitivity to light or noise, blurred vision, difficulty remembering, and difficulty concentrating.

Exclusion Criteria:

Neurological disorders prior to concussions (e.g.: seizure disorder); systemic illnesses known to affect the brain (e.g., diabetes and lupus); a history of psychotic disorder; known developmental disorders (e.g., attention deficit disorder, dyslexia); history of migraines; and, active engagement in litigation.
Study of AZD1222 for the Prevention of COVID-19 in Japan

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1 and D1), or aged ≥ 70 years (Subcohorts B2 and D2)

Exclusion Criteria:

1. Known past laboratory-confirmed SARS-CoV-2 infection
2. Positive SARS-CoV-2 RT PCR test at screening
3. Seropositivity to SARS-CoV-2 at screening.
4. Significant infection or other illness, including fever \> 37.8°C on the day prior to or day randomization
5. History of Guillain-Barré syndrome
6. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)
7. History of allergy to any component of the vaccine
8. Any history of angioedema
9. Any history of anaphylaxis
10. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
11. History of serious psychiatric condition likely to affect participation in the study
12. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
13. Suspected or known current alcohol or drug dependency
14. Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data
15. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
Internet-delivered CBT for Functional Abdominal Pain in Adolescents - a Pilot

This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.

Functional abdominal pain (FAP) and functional dyspepsia, are common in adolescents and associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with FAP and FD.

Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-17 at inclusion date
* fulfilling Rome III-criteria for FAP or FD with:

  1. a written diagnosis from patient's physician and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin)
  2. The Rome III questionnaire + clinical interview confirming the diagnosis

Exclusion Criteria:

* Concurrent serious medical conditions
* Concurrent serous psychiatric diagnosis
* On-going psychological treatment
* Absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT
* On-going abuse or severe parental psychiatric illness in the family
* Pronounced language skill deficits and learning difficulties lead to exclusion from the study
* Lack of regular internet-access
Study of Losartan in the Treatment of NAFLD in Children

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of mortality and natural history studies of adults show that NAFLD is an independent risk factor for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health standpoint, as it represents an early and possibly more aggressive form of the disease. Currently there is no effective treatment for pediatric NAFLD.

Losartan is an orally-administered angiotensin II receptor antagonist which is currently on the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has been shown to be important in many disease states including renal disease, cardiovascular disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed as a novel treatment of NAFLD in part because they would treat both the factors increasing cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic inflammation.

This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others. Safety will be assessed by the recording of adverse events, clinical laboratory parameters, vital signs and physical examinations.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \> 85th% for age and gender
* History of definite or borderline nonalcoholic steatohepatitis (NASH) diagnosed by liver biopsy using NASH Clinical Research Network (CRN) criteria
* At least 2 months of attempted lifestyle changes after liver biopsy
* Current ALT ≥ 3 times normal (69 U/L for girls, 78 U/L for boys) at enrollment
* Glomerular filtration rate (GRF) \> 90
* Weight ≥ 62.5 kg

Exclusion Criteria:

* Other chronic illness requiring daily medication (except medications for mild mental illness, acid reflux, allergies, stable attention deficit hyperactivity disorder (ADHD), or asthma)
* Supplement or anti-oxidant therapy within past 2 weeks
* Renal insufficiency
* Cirrhosis and liver synthetic dysfunction (International Normalized Ratio ≥ 1.5)
* History of hypotension
* Diabetes (or fasting glucose \> 125 mg/dL)
* Acute illness within past 2 weeks prior to enrollment (fever \> 100.4ºF)
* Pregnancy
A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth

The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Model-based Iterative Reconstruction (MB-IR VEOTM) in Ultra Low-dose Abdominal CT Versus Adaptative Statistical Iterative Reconstruction (ASIR): A Prospective Study for Acute Renal Colic

The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).

Renal colic is a common recurrent pathology in young patients, multi explored by imaging such as CT and abdominal radiography.

Abdominal MDCT(MultiDetector Computed Tomography) without injection is the gold standard in diagnosis of acute flank pain suspect of renal colic due to high sensitivity (96%) and excellent specificity (100%).

The increased use of medical imaging examinations using ionizing radiation (+57 % between 2002 and 2007) makes it essential to optimize protocols, including CT-scans which represents 10.1 % of procedures and 58 % of the collective effective dose.

Model-based iterative reconstruction (MB-IR VEOTM) (GE Healthcare, Milwaukee, WI) can use a low dose acquisition, reducing the effective dose delivered to the patient almost 80% comparing a standard CT with the last algorithm: adaptative statistical iterative reconstruction (ASIR).

MB-IR VEOTM shows great potential for substantially reducing radiation doses at routine abdominal CT. ASIR is limited in this regard owing to reduced image quality and diagnostic capability. Further investigation is needed to determine the optimal dose level for MBIR(Model Base Iterative Reconstruction) that maintains adequate diagnostic performance. In general, objective and subjective image quality measurements do not necessarily correlate with diagnostic performance at ultralow-dose CT.

Objective:

Prospective clinical study, equivalence between two CT protocols for the diagnosis of acute renal colic.

Show that a low dose acquisition with model based iterative reconstruction (MB-IR VeoTM) is as good as a standard CT with adaptative statistical iterative reconstruction (ASIR) in the diagnosis acute renal colic

Eligibility Criteria:
Inclusion Criteria:

* Informed and a written consent
* Acute flank pain needed abdominal CT exploration.

Exclusion Criteria:

* Juvenile patients
* Pregnant women
Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation

The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized patients (in a medical care ward) for at least 3 months, or ambulatory patients
* Suffering from chronic constipation defined as:

  * either less than 3 stools per week for at least 3 months and no or partial efficacy of dietary advices, OR
  * patient treated with laxative medication/s for at least 3 months before inclusion, because of chronic constipation corresponding to less than 3 stools per week in case of no laxative treatment
* patient has less than 3 stools during 7 consecutive days of the screening wash-out period

Exclusion Criteria:

* known organic intestinal disease
* having had intestinal surgery
* abdominal or pelvic radiation, carcinoma, obstructive disease, malabsorption disease
* fecal mass in the rectum which cannot be completely evacuated during the screening wash-out period
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

The aim of the present study was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion and patient-controlled epidural analgesia with ropivacaine/fentanyl in off-pump coronary artery bypass grafting

Ninety-three patients were scheduled for off-pump coronary artery bypass (OPCAB) under propofol/fentanyl anesthesia. Day before surgery patients were asked for informed consent and randomized into three postoperative analgesia regimens aiming at a visual analog scale (VAS) score \<30 mm at rest. The control group (n=31) received intravenous fentanyl 10 µg/ml postoperatively 3-8 mL/h. After placement of an epidural catheter at the level of Th2-Th4 before OPCAB, a thoracic epidural infusion (EI) group (n=31) received epidural anesthesia (EA) intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous EI of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. The patient-controlled epidural analgesia (PCEA) group (n=31), in addition to EA and EI, received PCEA (ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min) postoperatively. Hemodynamics and blood gases were measured throughout 24 h after OPCAB.

Eligibility Criteria:
Inclusion Criteria:

* presence of coronary artery disease
* ASA II-III
* elective off-pump coronary artery bypass

Exclusion Criteria:

* age \< 18 years
* severe valve dysfunction or peripheral vascular disease
* simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
* transfer to CPB during surgery
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
* WHO performance status 0,1,2,or 3
* No prior treatment of multiple myeloma
* Clear requirement of treatment (usually Durie/Salmon stage II or III)
* Anticipated life expectancy of at least 3 months
* Adequate organ function
* Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
* Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
* Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent

Exclusion Criteria:

* Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
* Benign monoclonal gammopathy
* Multiple myeloma of IgM without osteolytic bone lesions
* Smouldering myeloma
* More than 3 irradiation fields
* Irreversible performance status of WHO4
* Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
* Women of childbearing potential
* Preexisting peripheral polyneuropathy
* Congestive heart failure NYHA III, IV
* Acute infection requiring systemic antibiotics at study entry until resolved
* Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
* Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
Mindfulness Meditation Practice During Hemodialysis

This protocol of meditation is based on mindfulness program proposes to train meditation during the hemodialysis session. The investigators hypothesize that this program offered during hemodialysis session may promote well-being, reduce symptoms of stress and depression reported by the patients, which ultimately may improve biochemical parameters resulting from better adherence to treatment. Objectives: To evaluate the effects of mindfulness meditation practice in patients on chronic hemodialysis, in order to verify if this training can improve symptoms of depression, stress, quality of life and sleep disturbances. Methods: fifty patients will be separated in two groups, twenty five each group, half of them in the control group (CG) and the other half to the intervention group (IG). The patients will be evaluated pre- and pos-protocol.

Introduction: Chronic kidney disease (CKD) affects thousands of people in the world, regardless of gender, race and age. CKD requires dialysis or renal transplant. In the case of dialysis, cardiovascular and infectious events adversely impact the survival and quality of life despite technological advances. Recently, brain-renal interaction has emerged as a key aspect for understanding the neurological disorders-related to CKD, such as cerebrovascular diseases, cognitive impairment, and autonomic, sensory and motor neuropathies. In addition, patients on chronic hemodialysis develop sleep disorders, like insomnia and central apnea, restless leg syndrome, depression, anxiety and stress. Mindfulness meditation practice has been reported to positively affect cardiovascular parameters, since that practice contributes to the decrease in blood pressure levels and premature heart beats occurrence through sympathetic nerve modulation, which collectively may lead to improve the quality of life. Objectives: To evaluate the effects of mindfulness meditation practice in patients on chronic hemodialysis, in order to verify if this training can improve symptoms of depression, stress, quality of life and sleep quality. Methods: fifty patients will be separated in two groups, twenty five each group, half of them in the control group (CG) and the other half in the intervention group (IG). The IG will be enrolled in the meditation protocol, for 12 weeks, 3 days a week during the hemodialysis session, while the CG will wait. Then after the evaluations, the CG will receive the intervention of meditation, while the IG will not receive any intervention. The groups will be evaluate before, 3-and 6-month follow-up periods. We will apply the following instruments: ICED (Index of coexistent diseases), KDQOL (Kidney Disease Quality of Life), BDI (Beck Depression Inventory), PSQI (Pittsburgh Sleep Quality Index), PSS (Perceived Stress Scale), MAAS (Mindful Attention Awareness Scale) and SCS (Self-Compassion Scale).

Eligibility Criteria:
Inclusion Criteria:

* Be a patient at Einstein Dialysis Center
* Have signed the informed consent

Exclusion Criteria:

* Have not signed the informed consent
Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia

HPV vaccination has emerged as a strategy to reduce the risk of recurrence oafter excisional treatment. However, only few data are aviable. In this trial the investigators aim to assess the role of HPV vaccination in women traeted for HPV-related lesions

Patients treated for HPV-related disease are counseled about the potential protective role of HPV vaccination. The investigators will monitor the risk of HPV recurrence in pateints who choce to have vaccination and who did not.

Eligibility Criteria:
Inclusion Criteria:

* Treatment of HPV-related disease

Exclusion Criteria:

* Previous HPV vaccination
Comparison of AmblyzTM Glasses and Patching for Amblyopia

Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.

Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment.

The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment.

This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia.

Moderate amblyopia: Children ages 3 to \<8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group.

Severe amblyopia: Children ages 3 to \<8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.


Eligibility Criteria:
Inclusion Criteria:

* Both genders and all races are eligible to this study.
* Age 3 to 8 years
* Amblyopia associated with strabismus, anisometropia, or both
* Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
* Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \>3 logarithm of the minimum angle of resolution (logMAR) lines
* Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.

Exclusion Criteria:

• No amblyopia treatment before enrollment.