cyrilzakka/clinical-trials huggingface dataset:
Cognitive Training Intervention and Attitudes Towards Genetics

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

The investigators propose using an "off-the-shelf" product - Lumosity (http://www.lumosity.com/) - an online cognitive training program, to address the cognitive impairment in outpatient HCT survivors. The program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.

Ideally, targeting the intervention and offering it specifically to those at highest risk (integrating clinical and genetic markers) would ensure efficacy. However, evidence is lacking on whether patients are receptive to communication of individual genetic information and whether provision of such results would lead to enhanced intervention response. To realize the high expectations of personalized medicine, patients' preferences and attitudes need to be thoroughly investigated especially as more information on genetic risk becomes available. The investigators will examine patients' genetic knowledge to determine whether factual knowledge of genetics is essential for understanding genetic risk and for informing treatment decision making in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years old at time of allogeneic HCT performed at UAB
* Outpatient and between 3 and 6 months post HCT
* English speaking
* Possess access to an internet-connected home computer

Exclusion criteria:

* History of pre-existing neurological disorder or documented major psychiatric disorder; significant auditory, visual, or motor impairments
* Participated in neuropsychological intervention within the past 6 months
* History of color blindness
Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

A randomized clinical trial to evaluate the effectiveness of an instrumental rehabilitation protocol compared with standard protocol In patients with knee osteoarthritis.

This is a randomized clinical trial designed to compare two intervention aimed at reducing and improving knee function in patients with knee osteoarthritis

- sixty subjects suffering from knee osteoarthritis will be recruited; 30 per group.

A: instrumental rehabilitation B:standard rehabilitation All patients who meet the clinical inclusion and exclusion criteria will have a standard radiography

* selected patients will be invited to participate and will be informed of the purpose and conduct of the study
* patients will be randomized to either the instrumental rehabilitation programme groupe or the standard rehabilitation group
* patients in both groups will have a protocol that will be extended over 6 weeks
* participants will be assessed primarily for function and pain, as well as other secondary endpoints , at baseline at 3 weeks and at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with radiologically confirmed uni/ bilateral gonarthrosis

Exclusion Criteria:

* Will be excluded from our study:
* Subjects with congestive gonarthrosis (joint effusion at clinical examination).
* Patients followed for chronic inflammatory rheumatism.
* Patients who are candidates for surgery for knee osteoarthritis
* Patients with a pathology causing a limitation in walking distance apart from gonarthrosis.
* Amputees of one or both lower limbs.
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. The high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. For the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered.

Nowadays, proton pump inhibitors (PPIs) are considered the mainstay in the treatment of the patients with GERD; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged.

A local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. Based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.

GERD is one of the most common digestive pathologies, with a prevalence between 20% and 40% of adults. For the treatment of the disease, proton pump inhibitors (PPIs) have undoubtedly shown effective results; however, in around 30% of patients the complete resolution of symptoms fails.

For the latter, new therapeutic options should be considered. As a modern well-tolerated approach, and for local treatment, hyaluronic acid (HA) appeared to be an option for symptoms relief. HA is a glycosaminoglycan that acts as a natural defense for esophageal mucosa, able to organize the reticular structure as a filter to prevent the diffusion of high molecular substances. In addition, one of its remarkable features is the induction and control of epithelial cells turnover improving the re-epithelization process and the ulcer healing. In addition, hyaluronic acid compounds have shown no migration from the injection site in up to a three-year period.

Based on the above, the investigators aim to assess the effectiveness of hyaluronic acid in gastroesophageal reflux control, to considered it as an alternative effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old
* Patients with diagnosis of GERD (distal esophageal acid exposure time \> 6% on 24hour ambulatory pH-impedance monitoring)
* Patients with abnormal distal esophageal acid exposure time (4%-6%) on 24-hour ambulatory pH-impedance monitoring
* Patients who authorized for endoscopic approach.

Exclusion Criteria:

* Pregnancy
* Any clinical condition which makes endoscopy inviable.
* Patients with severe anatomic conditions such as esophageal strictures, Barret´s esophagus, hiatal hernias.
* Previous esophageal surgery.
* Patients with a history of upper gastrointestinal neoplasia.
* Inability to provide informed consent
Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma

The purpose of this study is to prospectively collect specimens from pediatric patients with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in order to characterize the molecular abnormalities of this tumor.

High grade diffuse intrinsic pontine glioma (DIPG) accounts for approximately 80% of pediatric brainstem tumors and 10% of pediatric brain tumors, and is the most lethal form of brainstem gliomas in children. There is currently no effective therapy to treat these tumors. We hypothesize that this tumor exhibits unique molecular abnormalities leading to altered RNA and protein expression. The aim of this trial is to collect specimens from pediatric patients with diffuse intrinsic pontine glioma including serum, cerebrospinal fluid, urine, brain tumor and other constitutional tissue, during therapy and/or at autopsy. Our goal is to study this tissue to characterize the genetic abnormalities that lead to tumor formation in order to identify key molecules as biomarkers which we can target to design and test new and more effective treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age with clinical and radiologic diagnosis of diffuse intrinsic pontine glioma
* Patients with other high-grade gliomas originating in the brainstem
* Patients with focal gliomas (WHO grade I/II) of the brainstem

Exclusion Criteria:

* Patients with any type of infiltrative low grade (WHO grade I and II) or high grade glioma (WHO grade III and IV) originating outside the brainstem
* Patients harboring primary brainstem tumors with other histologic diagnoses (e.g., PNET)
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.

Eligibility Criteria:
Inclusion Criteria

* elective cerebral aneurysm clipping surgery
* arteriovenous malformation surgery
* craniotomy
* American Society of Anesthesiologists 1,2 and 3

Exclusion Criteria:

* cardiac abnormalities
* coronary heart disease
* valvular heart disease
* pregnancy
Regenerative Endodontics in Mature Permanent Teeth

this study was designed to compare the clinical and radiographic success of REPs after using blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients free from any systemic diseases or genetic disorders.
* Children aged 9-13 years old of both sexes.
* Traumatically or cariously exposed single rooted mature permanent teeth which may be asymptomatic or manifested with dull ache pain, or spontaneous unprovoked toothache.
* Non-vital single rooted mature permanent teeth that indicated for endodontic treatment
* Swelling close to involved tooth accompanied with or without fistula.
* Negative response to cold \& electrical pulp test.
* Informed Consent.

Exclusion Criteria:

* Unrestorable teeth, or that need post and core for the final restoration.
* Immature permanent teeth.
* Known allergy, sensitivity to ciprofloxacin, metronidazol.
* Uncooperativeness of child and/or parents or caregiver's behavior.
* Presence of calcific metamorphosis inside root canals.
Glin3: Assessment of the Glycemic Responses to Nutritional Products

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Baseline fasting Glucose ≥6.1 at screening visit
* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy, non-smoking males or females, 18 and 55 years of age, inclusive
* BMI 18.0 and 32.0 kg/m2, inclusive
* non clinically significant 12-lead ECG
* heart rate of 45 to 90 beats per minute, inclusive
* mean systolic blood pressure \<141 mmHg and mean diastolic blood pressure \< 90 mmHg

Key Exclusion Criteria:

* history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome
* significant abnormalities in liver function tests
* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* history of Gilbert's Syndrome
* positive hepatitis panel
* seizure disorder or receiving anti-epilepsy medication for seizure disorder
* any acute or chronic condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study
Cardiotoxicity of Aluminum Phosphide Poisoning; Tropinin and CKmb as Early Biomarkers

Aluminum phosphide (AlP) or rice tablet is a cheap pesticide. When it comes in contact with acid (gastric acid) or moisture, it releases phosphine (PH3) gas. The heart,lungs, liver are the main targets in acute Aluminum phosphide (AlP) poisoning. Most deaths occur due to cardiovascular toxicity.

Aluminium phosphide is a potent respiratory chain enzyme inhibitor. Its most important effect is the inhibition of cytochrome c oxidase. The inhibition of cytochrome c oxidase and other enzymes leads to the generation of superoxide radicals and cellular peroxides , and subsequent cellular injury through lipid peroxidation and other oxidant mechanisms. It stimulates the production of hydrogen peroxide and reactive oxygen species, malonyldialdehyde (MAD), increases superoxide dismutase and inhibits catalase, peroxidase and glutathione . Oxidative stress is one of the main mechanisms of action of aluminium phosphide toxicity

Eligibility Criteria:
Inclusion Criteria: ALP poisoned cases

* admitted with free ECG

Exclusion Criteria:

concomitant ingesion of other drugs or toxins

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Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda

This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.

The purpose of this study is to assess the impact of the algorithm on antibiotic use.


Eligibility Criteria:
Inclusion Criteria:

* Age 2 months-5 years
* Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature \> 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate \> 30) OR cough

Exclusion Criteria:

* Age \> 5 years or \< 2 months at time of presentation
* Guardian not present to provide consent
A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants with Duchenne Muscular Dystrophy

The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping.

This is Phase 1/2, open-label, multi-center study consisting of 2 parts to evaluate the safety and tolerability of BMN 351 at escalating doses in participants with Duchenne Muscular Dystrophy (DMD) with genetic mutations amenable to exon 51 skipping.

Participants will be assigned to one of three groups called cohorts (Cohort 1, 2 or 3). Cohort 1 participants are further divided into Cohort 1A and Cohort 1B. In Cohort 1A, 3 participants will receive increasing doses once every 2 weeks with a visit to assess safety measures collected the week after dosing prior to escalating doses of BMN 351. In part 2, the participants in cohort 1A will transition to once weekly dosing. The participants in Cohort 1B, 2, and 3 will initiate low, medium, and high doses of BMN 351 and continue once weekly dosing at that same dose. The study will enroll approximately 18 participants.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 10
* Diagnosis of Duchenne muscular dystrophy with a specific genetic change amenable to exon 51 skipping
* Able to walk
* Not requiring assistance from a ventilator to breathe
* Currently on consistent doses of steroid treatment for the last 12 weeks

Exclusion Criteria:

* The participant will have some initial clinical labs and studies to assess baseline level of heart and lung function.
* Treatment with an exon skipping therapy within 12 weeks prior to the first visit.
* Any history of treatment with gene therapy
Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will test the influence of rs9557195 genoty (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes, mRNA expression of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migraton assay.

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). EBI2 is a G protein coupled receptors expressed on the immune cells. EBI2 directs migration and activity of immune cells.

Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will recruit patients with Crohn's disease and ulcerative colitis, assess epidemiological and clinical parameters (including clinical activity of IBD) draw blood, isolate lymphocytes, DNA and RNA.

The investigators will test the influence of rs9557195 genotype (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes (by FACS using an EBI2-antibody), mRNA expression (by qPCR) of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migration assay.

Eligibility Criteria:
Inclusion Criteria:

* Patient with IBD OR healthy volunteer
* No major uncontrolled medical/ surgical/ psychiatric condition requiring ongoing management besides IBD in the respective study groups. Well controlled conditions (i.e. medically controlled arterial hypertension, occupational asthma) may be present

Exclusion Criteria: none
Incidence of Tenderness Opposite to Adductor Canal in Patients Suffering From Osteoarthritis Knee Pain. A Cohort Study.

Knee osteoarthritis (KOA) is a common knee disorder. The pathological changes affecting the knee are typically examined by using X-ray imaging to assess the narrowing of the joint space and the presence of osteophytes. However, some previous clinical trials have revealed a discrepancy between the severity of joint pain and the image finding even with the use of knee MRI. Some studies have revealed that there are age-related changes in the type of fibers with the formation of a network of transverse fiber bands, and this may cause some compression or traction on the neurovascular content of the adductor canal. Other studies noted the presence of excessive yellow-colored adipose tissue that stretches or entangles some nerve fibers. The primary outcome of this study will be the incidence rate of tenderness over the midthigh corresponding to the AC in patients with KOA who are complaining of severe pain that is discordant with the radiological finding.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed KOA by symptomatic (rated knee pain \> four on a 10-point numeric rating pain scale (NRP scale)) and radiologically (Kellgren-Lawrence grades I, II ) findings

Exclusion Criteria:

* Post-traumatic knee osteoarthritis, oncological diseases, endocrine diseases (gout, diabetes), autoimmune diseases (rheumatoid arthritis), infectious diseases and patients with a history of previous knee surgeries or endoscopies
The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.


Eligibility Criteria:
Inclusion Criteria:

* evidence of CHC;
* evidence of hepatitis C non-genotype 2 or 3;
* compensated liver disease.

Exclusion Criteria:

* infection with HCV genotype 2 or 3;
* history of having received systemic antiviral therapy with activity against CHC \<=3 months prior to start of study;
* hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
* history or evidence of a medical condition associated with chronic liver disease other than CHC.
Study of a Pandemic Influenza Vaccine in Elderly Participants

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants

Exclusion Criteria:

* History of clinically significant medical conditions
* History of Guillain-Barre syndrome or active neurological disease
* Resident of nursing home or long-term care facility