cyrilzakka/clinical-trials huggingface dataset:
Serological Response to Antipneumococcal Vaccination and Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Adults

S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain and their nasopharyngeal isolates have features similar to subsequent invasive strains. A 23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+ population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+ are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins results in an improved T-cell dependent immune response, characterized by increased antibody concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that are the main target of conjugate vaccines licensure. Some trials showed a better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23. However these data were not unequivocally confirmed in further studies on the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same or even better response compared to PPV23, with a safety and tolerability similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal infections. The purpose of this study is to evaluate serological response and prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following vaccination with 2 doses of PCV13.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* obtained informed consent
* outpatient
* CD4 ≥200 cells/µl in the last two evaluations before T0

Exclusion Criteria:

* \> 65 years old
* presence of acute infectious disease
* antibiotic therapy (ongoing or in the previous \<= 7 days)
* previous PPV23 or PCV7 vaccination
* Pregnancy
* Current immunomodulatory therapy
* Immunosuppression not HIV related
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds

Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Type II diabetes and having a foot ulcer
* Being in the 1st or 2nd category according to the Wagner classification
* Not to have a serious musculoskeletal, cardiac, neurological, etc. systemic disease that may interfere with the research.
* Not having any communication problems
* Having the same wound care procedure
* Not taking any other treatment that may have an effect on the wound.

Exclusion Criteria:

* Individuals with a diagnosed psychiatric illness,
* Individuals who have received any physiotherapy treatment in the last 3 months,
* Individuals with acute infection,
* Individuals with toe pressure \< 40 mmHg
* Individuals with Charcot Foot and/or osteomyelitis
* Individuals with venous ulcer disease
* Individuals who are morbidly obese (BMI \>40) according to body mass index
* Individuals with incurable proliperative retinopathy
Community Activation for Prevention (CAPs): A Study of Community Gardening

The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners.

The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent in English or Spanish
* Aged 18 or over
* Currently on the wait list for a new garden
* Not have gardened in the past 2 gardening seasons

Exclusion Criteria:

* Is not able to complete the study requirements in Spanish or English
* Aged 17 or younger
* Has gardened in the past 2 gardening seasons
Oat Beta-glucan as a Supplement in Chilean Type 2 Diabetics

Objective: To evaluate the effect of oat β-glucans on the satiety perception, metabolic control and intestinal microbiota of type 2 diabetics from Talca, Chile. Methodology: Clinical trial, controlled, randomized, double blind and parallel design. The recruited (40 subjects) were randomized into two groups, placebo (PL) and ß-glucan (BG). 5 gr of oat ß-glucan or placebo were delivered for 12 weeks to be added in breakfast. Blood and stool samples were requested at the beginning and at the end of the intervention. The investigators quantify: HbA1c in whole blood, fasting blood glucose, basal insulin, C-peptide, tumor necrosis factor alpha (TNF-a), interleukin (IL) 6, IL-8, IL-10, IL1β, cortisol, ghrelin, glucagon-like peptide type 1 (GLP -1), YY peptide (PYY), Resistin, Leptin and serum Lipid Profile. The subjective perception of hunger / satiety were established through an analogous visual survey. Calorie intake was determined by 24-hour recall survey. Were analyzed the phylum: Firmicutes, Bacteroidetes and Verrucomicrobia, and the populations of Bifidobacteria spp, Lactobacillus spp, butyrate producing bacteria, Akkermansia Muciniphila and total bacteria of fecal microbiota, using quantitative polymerase chain reaction (qPCR) with specific primers. All participants were instructed not to make changes in their usual eating habits, physical activity and pharmacological treatments.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Use of oral hypoglycemic agents (Metformin)
* 30 to 45 years
* More than one year and less than 10 diabetes
* no major chronic complications
* Hb A1c between 7 to 9%
* BMI between 30-35 Kg / mt2.

Exclusion Criteria:

* Pregnant women
* Acute and / or chronic intestinal pathologies (malabsorption syndrome, celiac disease, chronic inflammatory bowel diseases, among others.),
* Drugs that interfere with the microbiota (antibiotics, anti-inflammatories, laxatives, prokinetics),
* Organic insufficiencies (cardiac, hepatic, renal, respiratory), or with immunodeficiencies (HIV, chemotherapy, radiotherapy, transplanted).
* Presence of smoking habit.
* Regular probiotic or prebiotic intake (more than 2 months)
* Dipeptidyl peptidase 4 inhibitors (DPP4) and α-amylase inhibitor drugs.
Hemodynamic and Salivary Responses of 12 Weeks of Training With Different Anti-hypertensive

Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.

Cardiovascular diseases are the leading causes of death and postmenopausal women. Physical exercise, in turn, is a strategy to reduce cardiovascular stress, by decreasing the blood pressure (BP) at rest and several risk factors associated with sedentary lifestyle, thus improving the quality and life expectancy of these women. However, different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women. The volunteers will do cardiovascular and biochemistry evaluations before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 50 and 70 years;
* Be in the postmenopausal phase;
* Be able to practice physical exercise on treadmill and bodybuilding,
* Receive a release certificate for exercise practice;
* Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
* In the case of hypertensives: present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension (2010);
* In the case of hypertensive patients, undergo drug treatment with β-blockers or Angiotensin receptor blockers.

Exclusion Criteria:

* Present history of stroke or acute myocardial infarction;
* Smokers;
* Present diagnosis of Diabetes Mellitus or renal pathologies;
* Use of antihypertensive drugs from classes that were not selected for this project;
* Make use of hormonal therapies;
* Being uncompensated hypertensive.
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified

Exclusion Criteria:

* Use of ketorolac is contraindicated
* Use of general anesthesia is contraindicated
* Has a medical condition that could adversely impact subject participation
* Has diabetes mellitus and glycosylated hemoglobin (HbA1c) \>9.5 or history of prolonged uncontrolled diabetes
* Body mass index (BMI) less than 18 or greater than 35
* Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates
* Known or suspected sleep apnea
* History of Hepatitis B or C
* Has a psychiatric disorder that impairs capability of subject to report pain
* Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia
In Depth Observational Clinical Trial Of Retinitis Pigmentosa Patients

Typically, clinical research participation favors a specific demographic group, and little research exists on how trial attributes affect participation. As such, this study seeks to analyze data from different demographic groups and check for recurring trends that could provide valuable insights for future retinitis pigmentosa patients.


Eligibility Criteria:
Inclusion Criteria:

* Is 18+ years old
* Confirmed diagnosis of retinitis pigmentosa
* Signed Written Informed Consent

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Participant is actively receiving study therapy in another trial
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN).

The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult persons aged 16 years or older at the time of informed consent.
* Minimum of 6 months on Parenteral supplementation.
* Established clinical diagnosis of IFALD based on a persistent elevation of

  1. liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal \[ULN\]) for ≥6 months and/or
  2. total bilirubin \> ULN for ≥6 months.
* Laboratory parameters consistent with stable liver disease without cirrhosis as defined by:

  1. ALT and AST \<5 × ULN;
  2. Total bilirubin ≤2.5 mg/dL in the absence of Gilbert's Syndrome.
  3. Serum albumin ≥2.5 g/dL;
  4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
  5. Platelet count ≥120,000/mm3.

Key Exclusion Criteria:

* Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease.
* Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and/or signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy).
* Presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage liver disease (MELD) score \>12.
* Transient elastography read \>20.0 kPA within 3 months prior to or during the Screening Period.
* Estimated glomerular filtration rate \<45 mL/min based on the 2021 CKD-EPI creatinine equation.
* Poor nutritional status defined as body mass index (BMI) \<17 kg/m2.
BioGene Bank Cohort Study for Approved Research Requests

The BioGene bank: Is a centralized collection of human blood samples along with de-identified (coded) health information, environmental factors, family disease histories and information from DNA. Limited to the NSLIJHS catchment area.

The purpose of the BioGene Bank Cohort is to collect blood and store DNA from blood, along with health information to study how genetic variation in the population is associated with particular diseases, treatments and medical outcomes. Investigators may study the entire range of diseases and medical problems that exist within the NSLIJHS, including medical, surgical, psychiatric, pediatric and obstetric conditions. The specimens and medical information will be kept at a central Biorepository. This research study does not involve any treatment and individual research results are not provided.

Eligibility Criteria:
Inclusion Criteria:

* Anyone receiving care at the NS LIJ Health System would be eligible to join the BioGene Bank Cohort.
* Participants' family members who may or may not have medical records at NSLIJHS.

Exclusion Criteria:

* Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
* Patients unable to provide a blood sample because it would adversely affect their health or who refuse to provide blood sample or share future discarded biological samples.
* Patients \<10kg in weight
Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.

We live in an increasingly aging society in which the incidence of osteoarticular diseases increases, among which osteoarthritis (OA) stands out. OA is a degenerative disorder of the different components of the joint leading to a progressive destruction of the same. The hip and knee being the most affected joints, OA presents multiple symptoms such as pain, stiffness and functional limitation, also causing psychological disorders such as anxiety, depression, quality of sleep and poor perception of quality of life. Conventional treatment is aimed at alleviating symptoms, but when conservative therapies fail in the more advanced stages of the disease, total joint replacement surgery or arthroplasty is the therapeutic option of choice. Strength physical exercise (PE) and aerobic training have been shown to be effective in OA, obtaining positive effects on the symptoms and on variables that deteriorate this disease. The concept of pre-habilitation or preoperative rehabilitation has been shown through other studies in different pathologies (cardiopulmonary and musculoskeletal) to have positive effects at a clinical and functional level, however, the planning of a pre-habilitation protocol in hip or knee arthroplasty is still controversial.

The purpose of this study is to determine the effect that a prehabilitation program will produce and its possible usefulness in those subjects who are waiting for a hip or knee arthroplasty. It is expected to find favorable results that support this therapy when it comes to reducing postoperative recovery times, functional capacity and other psychological variables of interest.

This powerful tool could represent a non-pharmacological and non-invasive therapy, as well as being useful and economical in the management of patients with OA in advanced stages.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hip OA stage I-III of the Tönnis classification or diagnosis of knee OA stage I-IV of the Ahlbäck classification
* Patients requiring hip/knee arthroplasty surgery
* Signed informed consent
* Obtaining a score equal to or greater than 8 repetitions in the Sit to Stand test
* Patients with the ability to walk without technical aids or in need of some help (up to two canes or a walker)

Exclusion Criteria:

* Cognitive deficit/Dementia states
* Cancer processes
* Associated vascular and inflammatory pathologies
* Associated neurological pathologies
* Contraindications to physical exercise
CelAgace™ OraRinse Solution for Treatment of Candidiasis

CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.

Eligibility Criteria:
Inclusion Criteria:

* Radiation induced oral mucositis with resulting candidiasis
* Chemotherapy induced oral mucositis with resulting candidiasis
* Oral mucositis due to being immunocompromised with resulting candidiasis
* Stomatitis due to other causes with resulting candidiasis
* Currently have mild to moderate mucositis

Exclusion Criteria:

Patient:

* under the age of 18
* pregnant or breastfeeding
* inability to use an oral rinse
* hypersensitivity to Aloe Vera and/or Silver
* whose candida rinse culture was performed greater than 10 days prior to study entry.
* has any sort of removable dental appliance
* with previous or current history of any cancer of the oral cavity
* who received therapy for candidiasis within the past 30 days
* who used antifungal medication in the last 30 days
* who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
* with impaired renal or hepatic function
* receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties.

Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18
* Patient has received chemotherapy, radiation, or a combination of both.
* Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.

Exclusion Criteria:

* No ongoing pharmacological management of ADHD
* Not currently pregnant
Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (over 18 yo),
* Male or female,
* Affiliated to social security,
* Without any contraindication to MRI exam and who will have signed a written inform consent.

Exclusion Criteria:

* Individuals deprived of liberty,
* Under guardianship or curatorship,
* Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
* Pregnant women,
* Breastfeeding women,
* Women without effective contraception,
* Participants who refused to be informed of the possible discovery of a significant anomaly,
* Persons involved in an interventional study with a drug or an implantable device.