cyrilzakka/clinical-trials huggingface dataset:
Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis

The investigators seek to assess esophageal inflammation or lack of it in response to treatment with a novel non-invasive method that would measure eosinophil-associated inflammatory mediators in the blood and urine to determine the presence of active Eosinophilic Esophagitis. For these purposes, the investigators will correlate esophageal inflammatory mediators measured in blood and urine with histological findings identified on esophageal mucosal biopsies. Additionally, biopsies associated mediators will be assessed relative to clinical phenotype and outcome.

The diagnosis, assessment of recurrence of inflammation, response to treatment and remission in EoE are all currently based on histological evaluation of upper endoscopic pinch esophageal biopsies. Obtaining biopsies for histological evaluation by this procedure is both invasive and expensive. The purpose of our longitudinal prospective study is to evaluate and quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and urine of subjects with EoE and compare their presence and levels with the presence or absence of measures of inflammation in esophageal biopsies. While evaluation of esophageal biopsies with 15 or more eosinophils per high power field is the gold standard for diagnosis of EoE, novel predictors of clinical outcome remain unclear. The objective is to identify one or more sensitive and specific non-invasive biomarkers that could be used to monitor esophageal inflammation, and identify novel tissue-based markers that identify phenotype and outcome. This would eliminate the need for invasive serial surveillance endoscopies for the purpose of evaluating for recurrence of inflammation or response to standard therapy since symptoms alone do not adequately correlate with either the presence or absence of disease activity (inflammation) in the esophagus of patients with EoE.

Eligibility Criteria:
Inclusion Criteria:

* Patient ages 1-18 undergoing upper endoscopy for suspected esophageal disease or esophageal inflammation or has histologically confirmed esophageal inflammation may be included in this study

Exclusion Criteria:

* Patients with a history or current diagnosis of esophageal malignancy or subjects with graft versus host disease will be excluded from the study.
* Patients that are considered at high risk for biopsies at the discretion of the child's physician and/or the researcher
* Patients with known bleeding disorders or patients with illnesses where bleeding would pose a threat to their health
* Diagnosis other than Eosinophilic Esophagitis (EoE) i.e. Inflammatory Bowel Disease (IBD), Gastroesophageal Reflux Disease (GERD)
Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

Spasticity is one of the most common features in children with cerebral palsy (CP) and is evident in the majority of CP types such as hemiplegia, diplegia, quadriplegia, etc. Children with spastic upper motor neuron lesions often experience difficulties with muscle tone and movement, impacting their functional abilities and quality of life. Conventional treatments such as physical therapy and medication have demonstrated positive effects in the management of spasticity. However, alternative interventions like whole body vibration (WBV) have gained attention due to their potential to modulate muscle tone and improve functional outcomes. WBV involves the transmission of mechanical vibrations to the whole body or specific body parts. These vibrations stimulate sensory receptors and elicit muscular responses, potentially leading to improved muscle tone regulation and reduced spasticity.

Several studies have investigated the effects of WBV on spasticity management. These studies have reported various outcomes, providing valuable insights into the potential benefits of this intervention. Previous studies showed an immediate reduction of spasticity of the calf muscle, increased the range of the popliteal angle, and improved step length, step width, foot angle, and walking speed.

The current study seeks to address some of the limitations observed in previous research. It employs a randomized controlled trial design with a predetermined sample size, enhancing the statistical power and generalizability of the findings. The intervention group will receive supervised upper limb exercises using WBV, while the control group will receive conventional therapy. By comparing these two groups, the study aims to provide more robust evidence regarding the specific effects of WBV on muscle tone and spasticity. Furthermore, the current study will utilize standardized assessment tools to measure muscle tone, spasticity, and functional outcomes pre-and post-intervention. This will allow for a comprehensive evaluation of the effects of WBV on spasticity management, encompassing both objective measures and functional improvements.

Eligibility Criteria:
Inclusion Criteria:

* age between 5 and 14 years,
* who had a diagnosed with spastic cerebral palsy by a pediatrician,
* 1-3 on Ashworth Scale (MAS) for upper limb muscles
* whose parents/guardians sign the informed consent,
* who were willing to complete the study.

Exclusion Criteria:

* Children with anatomical disorder or deformity in the upper limb,
* Children who received a botulinum toxin injection in the upper limb muscles during the last six months
* Surgery in the lower extremity during the previous year
* Severe associated neurological diseases as epilepsy
* Poor nutritional status.
* Those who do not agree to participate in the study.
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* A patient who was administered Somatropin (Genotropin).

Exclusion Criteria:

* N/A.
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of non-childbearing potential.
* Men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²).
* Able to comply with all study procedures, including the 5- to 6-night stays at the CRU and the follow-up phone call.
* Healthy participants: In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee).
* Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.

Exclusion Criteria:

* Females who are lactating or of childbearing potential.
* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  1. Metabolic disease
  2. Gastrointestinal disease
  3. Hematological disease
  4. Neurological disease
  5. History or presence of clinically significant cardiovascular disease.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
Intestinal Microbiota in Patients Before and After Bariatric Surgery and Healthy Controls

Studying obesity and metabolic syndrome attention is focused more and more on gut microbiota. In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations of gut microbiota, which seem to be favourable. In this study the investigators aim to examine the effect of different bariatric procedures on composition of gut microbiota.

The human gastrointestinal tract is home to an extremely numerous and diverse collection of microbes communities, collectively termed the "intestinal microbiota". This amazingly complex and poorly understood group of communities has an enormous impact on humans. Indeed, microbiota is considered to play a number of key roles in the maintenance of host health, including aiding digestion of otherwise indigestible dietary compounds, synthesis of vitamins and other beneficial metabolites, immune system regulation and enhanced resistance against colonization by pathogenic microorganisms. Conversely, the intestinal microbiota is also a potent source of antigens and potentially harmful compounds. Schematically, humans can be considered to exist in a state of natural balance with their microbial inhabitants. A shift in the balance of microbiota composition such that it may become deleterious to host health is termed "dysbiosis". Dysbiosis of the gut microbiota has been implicated in numerous disorders, ranging from intestinal such as inflammatory bowel diseases and colorectal cancer to disorders with more systemic effects such as diabetes, obesity, insulin resistance and steatohepatitis. The link between the microbes in the human gut and the development of obesity, cardiovascular disease and metabolic syndromes, such as type 2 diabetes, is becoming clearer but, because of the complexity of the microbial community, the functional connections are less well understood.

In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations of gut microbiota, which seem to be favourable. In this study the investigators aim to examine the effect of different bariatric procedures on composition of gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* 30 healthy controls: BMI 18-30kg/m2 good general health
* 40 morbidly obese patients (BMI \>35kg/m2) scheduled for either sleeve gastrectomy or gastric bypass surgery

Exclusion Criteria:

* Antibiotic therapy within the last 2 months before enrolment
* regular intake of proton pump Inhibitors (PPI)
* previous surgery on the gastrointestinal tract (appendectomy acceptable)
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.


Eligibility Criteria:
Inclusion Criteria:

* New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
* ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study.
* Randomization is expected within 12 hour of admission to the ICU

Exclusion Criteria:

* Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding.
* Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia)
* Bone marrow disorder (e.g. aplastic anemia, marrow infiltration disorder, chemotherapy within the last 8 weeks)
* Jehovah's Witnesses
* Patient is comfort care measures only
* Refractory shock: mean arterial blood pressure below 60 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min
* Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical admission diagnosis
* Pregnancy
* Current prisoner
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.

Eligibility Criteria:
Inclusion Criteria:

* Any patient greater than or equal to 18 years of age.
* Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release

Exclusion Criteria:

* Any patient identified outside of the proposed study time period.
* Any patient receiving revision surgery
* Patients who have had prior ipsilateral palmar or finger surgery
* Patients with Dupuytren's disease
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients

To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)


Eligibility Criteria:
Inclusion Criteria:

1. Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)"
2. Subject is 30 years \< \> 80 years at the time of informed consent
3. Hoehn \& Yahr stage 1- 3
4. Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test

Exclusion Criteria:

1. Subject has previously participated in a trial with SPM 962
2. Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
3. Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
4. Subject has orthostatic hypotension
5. Subject has a history of epilepsy, convulsion and other
6. Subject has a complication of serious cardiac disorder/arrhythmia or has the history
7. Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
8. Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
9. Subject has congenital long QT syndrome
10. Subject has serum potassium of less than 3.5 mEq/L at screening test.
11. Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
12. Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
13. Subject has a history of allergy to topical medicine, e.g. transdermal patch
14. Subject is pregnant, nursing, or is child bearing potential while the trial
15. Subject is receiving therapy with prohibited drug specified in the study protocol
16. Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant
17. Subject has dementia
18. Subject is unable to give consent
19. Subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment
20. Investigator judges that subject is inappropriate as a study subject with other reasons
Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

Smoking has been identified as a key risk factor for the development of cardiovascular diseases (CVD). It was found that a persistent increase in levels of oxidative stress and prolonged inflammation play a pivotal role in the pathogenesis of smoking associated CVD. Oligomeric proanthocyanidins (OPCs) are widely known for their anti-oxidant and anti-inflammatory effects, in vitro and in vivo. However, there are hardly any studies available that systematically investigated their acute and long-term effects on vascular function as well as on established biomarkers of oxidative stress and inflammation in an "at risk" population such as smokers.

Therefore, the aim of the present study is to investigate the effects of an eight-week supplementation with OPCs on vascular function as well as biomarkers of oxidative stress and inflammation in blood of smokers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years
* BMI ≥ 20 and ≤ 27 kg/m2

Exclusion Criteria:

* Occurence of any adverse event, in particular those which require the use of medication that might interfere with the effects and/or the uptake of the investigational products
* Intolerance of study products
* Occurence of a serious adverse event
* Use of supplements, functional foods and/or other products containing vitamins, antioxidants and polyphenolic compounds or other ingredients with potential influence on vessel function for at least one month before the beginning of the study and during the entire study
* Use of a medically prescribed diet or slimming diet
* Vegetarian or vegan lifestyle
* Excessive alcohol consumption (\< 28 consumptions (approximately 250 g alcohol) per week)
* Participation in a clinical trial within 4 weeks before the study
* Non-compliance with the demands of the study
Brazil Nuts Effects on Selenium Status and Cognitive Performance

Some studies reported that selenium status is associated with cognitive function. However only a few reports have investigated whether selenium supplementation can benefit cognitive performance and in most of them selenium supplementation was not exclusive. Also, none of those reports have used foods rich in selenium as a source of supplementation. Thus, the aim of our study was to investigate whether the consumption of Brazil nuts improves cognitive function. We hypothesized that the daily consumption of Brazil nuts would have benefits on selenium status, increase antioxidant enzyme activity and improve cognitive function in older adults with MCI.

We enrolled older patients with MCI who attended the Memory and Aging Unit of the Geriatrics Division, University of São Paulo Medical School (Brazil). All participants fulfilled the criteria proposed by the International Working Group on Mild Cognitive Impairment (Winblad et al., 2004), which include the following: (1) the person is neither normal nor demented; (2) there is evidence of cognitive deterioration shown by subjective report in conjunction with objective cognitive deficits; and (3) activities of daily living are preserved and complex instrumental functions are either intact or minimally impaired. The diagnosis of MCI was based on a comprehensive neuropsychological assessment which included the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery (Welsh et al., 1994; Bertolucci et al., 2001). Participants were recruited from May 2011 to August 2012. Eligible subjects were aged 60 years or older, fluent in Portuguese, and free of any other significant neurologic or psychiatric diseases. None of them presented major depression or psychosis, had a regular intake of Brazil nuts, used supplements with selenium, or had intolerance to oleaginous food. An informed consent was obtained before the interview from all participants. The research protocol was approved by the Research Ethics Comittee of the Faculdade de Ciências Farmacêuticas da Universidade de São Paulo.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 years or older,
* fluent in Portuguese,
* free of any other significant neurologic or psychiatric diseases

Exclusion Criteria:
Pharmacokinetic Study on Raltegravir and Lamotrigine

The purpose of this study is to determine whether interactions between raltegravir and lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine before used in HIV patients.

Lamotrigine is an anticonvulsive drug that is used both for the treatment of HIV-associated neuropathic pain and the treatment of epilepsy in HIV-infected individuals. Lamotrigine is metabolized via glucuronidation.

Raltegravir is a newly developed integrase inhibitor that is also metabolized via glucuronidation.

Since both agents are metabolized via glucuronidation, there is a possibility of competition for glucuronidation, leading to drug-drug interactions between raltegravir and lamotrigine.

This primary objective of this study is to determine the effect of raltegravir on the pharmacokinetics of single dose lamotrigine (by intrasubject comparison). A secondary objective is to determine the effect of single dose lamotrigine on the pharmacokinetics of raltegravir when compared to historical controls. Another secondary objective is to evaluate the safety of combined use of single dose lamotrigine and raltegravir.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55 years of age
* Subject does not smoke more than 10 cigarettes, 2 cigars or 2 pipes per day
* Subject has a Quetelet Index of 18 to 30 kg/m2
* Subject is able and willing to sign informed consent
* Subject is in good age-appropriate health condition
* Subject has a normal blood pressure and pulse rate

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to medicinal products or excipients
* Positive HIV test
* Positive hepatitis B or C test
* Therapy with any drug (2 weeks preceding dosing) except for paracetamol
* Relevant history or presence of pulmonary disorders, cardiovascular
* History of or current abuse of drugs, alcohol or solvents
* Inability to understand the nature and extent of the trial and procedures
* Participation in a drug trial within 60 days prior to the first dose
* Donation of blood within 60 days prior to the first dose
* Febrile illness within 3 days before the first dose