cyrilzakka/clinical-trials huggingface dataset:
PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites

The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.

The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients.

Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis:

1. Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ.
2. PPARγ target genes are induced in monocytes from losartan-treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 19-80
* Sex: male or female
* Prior diagnosis of treated hypertension
* Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case);
* or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control).

Exclusion Criteria:

* Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPARγ)
* Therapy with glitazones for the past 21 days.
A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers

A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.

This is a randomised, double-blind, placebo-controlled, two-period crossover study, to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in the first treatment period and the alternate treatment in the second treatment period. Dosing in each period will be for 15 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this study.

Exclusion Criteria:

* Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results.
Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)

Dupuytren's disease is a progressive disease due to unknown causal agents or genetics.

Dupuytren's disease contains nodules and cords in the fascia as the epicenter of disease progression. Nodules contain whorls of collagen bundles and are densely packed with contractile fibroblasts and myofibroblasts. These highly contractile cells are linked to the fascia matrix through transmembrane integrin receptors. The cytoplasmic tail domains of the alpha beta integrin receptors provide a structural link between extracellular matrix and the actomyosin cytoskeleton.

Complications of surgical partial or total aponeurectomy in Dupuytren's disease are reported in up to 10% of cases . Often, surgical complications lead to compromised flexion limiting grasping function of the involved hand . A recent 20-year-review of the literature included 41 clinical trials with complication rates reported from 3.6%to 39.1% . 16% major complications occurred with 3% digital nerve injuries, digital artery injuries in 2%, infections in 2%, and complex regional pain syndrome in 6%. Besides selective or total aponeurectomy, soft-tissue distraction has been suggested using either pneumatic devices or external fixateur .

Non-invasive options include percutaneous fasciotomy or collagenase injection. The latter has been tested in a randomized-controlled trial published in the New England Journal of Medicine with 308 patients enrolled (NCT00528606) . Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. In the long-term the cords at the level of the proximal interphalangeal joint appear to more recurrent than at the metacarpophalangeal joint after collagenase injection with an eight year follow-up .

In early stage Dupuytren's contracture, radiotherapy has been suggested to limit disease progression. A cohort study of 135 patients with 208 hands involved received orthovoltage radiotherapy with a total dose of 30Gray separated by a six to eight week interval . After a follow-up of 13 years nodules and cords remained stable in 59%, improved in 10% and progressed in 31%.

Beside Dupuytren's disease, there are a number of further less common fibromatosis, such as knuckle pads, M. Ledderhose , of the plantar fascia and peyronie disease at the penis. The latter has been treated by extracorporeal shockwave therapy. A randomized-controlled trial using 2000 focused shock waves reduced pain significantly and improved erectile function and quality of life . About half of the patients in one series of 44 patients had a significant reduction in angulation following shockwave therapy .


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are patients aged 18 or over and 80 or younger
* Dupuytren's disease of stage 1-4 involving one or more fingers or the palm only

Exclusion Criteria:

* Exclusion criteria are suspected or evident pregnancy
* no Dupuytren's disease
* evident ulcerations
* no informed consent
* age under 18 years or above 80 years.
Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization

The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.

As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.

Eligibility Criteria:
Inclusion Criteria:

* Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture

Exclusion Criteria:

* Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
* Patient with BMI greater than 40
* Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
* Patients with documented allergic reaction to acetaminophen
* Patient with contra-indication to the use of acetaminophen (liver disease)
* Patients with a history of past or current alcohol, drug or opioid abuse
* Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids
Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Diagnosis of schizophrenia or schizoaffective disorder
* Known to have medication treatment adherence problems as identified by the TRQ (20% or more missed medications in past week or past month)
* Ability to be rated on psychiatric rating scales
* Willingness to take long-acting injectable medication
* Able to provide written, informed consent to study participation

Exclusion Criteria:

* History of allergy or intolerance to haloperidol or haloperidol decanoate
* Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment
* Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
* Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
* Immediate risk of harm to self or others
* Female who is currently pregnant or breastfeeding
Efficacy of a Patient Education Video

Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).

The study's overall goals are 1) to improve outcomes; and 2) to increase satisfaction with the physician consultation.

Patients will be randomized to intervention or control and data will be collected at three time points (before treatment, 30 days post-HSCT and 12 months post-HSCT).

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients scheduled for HSCT

Exclusion Criteria:

* Patients who have received HSCT previously
* Patients who do not speak English
Effects of Multimodal Therapy Versus Myofascial Release Techniques in Patient With Upper Cross Syndrome

Upper Cross Syndrome (UCS) is a frequent condition which is most commonly encountered in the musculoskeletal disorders showing a characteristics pattern of muscular imbalance and dysfunction in the joints of the neck and shoulder region. Upper Cross Syndrome remains a prevalent and debilitating condition, despite optimal approaches aimed at reducing pain and improving function.

This study investigates the additional benefits of Multimodal Therapy and Myofascial Release Technique in individuals with Upper Cross Syndrome. Rooted .The researcher employs a randomized controlled trial methodology. Participants are divided into two groups: one receiving Multimodal Therapy, and the other receiving Myofascial Release Techniques. Outcomes are assessed over a 6-week period, focusing on pain levels, Posture and functional disability by goniometer, Numeric pain rating scale (NPRS), Neck disability index (NDI) scores and REEDCO posture assessment scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by physician with sign and symptoms includes muscle in neck, chest and shoulder become overactive or underactive creating the X shape.
* Office worker.
* Aged 20 to 40 years.
* Male and females.

Exclusion Criteria:

* Recent trauma or surgery to the neck or shoulder region.
* Cancer or Metastasis in the neck or shoulder region.
* Infection or Abscess in the neck or shoulder region.
* Neurological conditions.
Exercise and Nutrition in IBD & Preconception

The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in preconception women with IBD. The investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with IBD, reducing inflammation, and improving fertility status in preconception women with IBD, as compared to either intervention independently.

Potential participants will be recruited from the Preconception and Pregnancy Clinic recently established within the Saskatchewan Multidisciplinary Inflammatory Bowel Disease Clinic \[MDIBDC\]. Eligible participants will be randomized \[stratified\] to one of four groups: 1) Exercise and dietary plan, 2) Exercise and no dietary plan, 3) Stretching \[placebo exercise\] and dietary plan, 4) Stretching and no dietary plan. Participants will be assessed at baseline, midway \[3 months\], and post-intervention \[6 months\] for indications of disease activity, quality of life, fertility status, and bone health.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Confirmed diagnosis of Inflammatory Bowel Disease
* Child-bearing age

Exclusion Criteria:

* Currently following a Mediterranean diet
* Currently performing resistance training on a regular basis (within the past 6 months)
* Failed Physical Activity Readiness Questionnaire-Plus (PAR-Q+).
* Past ileal pouch anal anastomosis
* Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety
Analysis of Oral Health of Students and Former Students of Undergraduate and Postgraduate Programs at the University of São Paulo.

This study aims to evaluate oral and systemic health conditions among students and former students of undergraduate and postgraduate programs at the University of São Paulo over five years. The primary focus is to understand how oral health impacts academic performance and attendance, providing insights for health promotion strategies within the university community.

The study employs a prospective cohort design to explore multiple health-related outcomes, including periodontal health, oral health literacy, and the prevalence of caries. The data collected will also examine social and behavioral predictors of oral health, such as dietary habits, stress, and use of substances like tobacco and electronic cigarettes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Current and former undergraduate and postgraduate students of the University of São Paulo.

Exclusion Criteria:

* 1. Individuals who do not consent to participate.
Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy

The aim of this study is to establish the diagnostic value of O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) PET-CT, \[18F\]-fluorocholine (FCH) and magnetic resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as reference.

The objectives of the study are:

* To demonstrate if the multimodal approach, combining the morphological aspect of the MRI with the metabolic aspect of the tumor with magnetic resonance spectroscopy (MRS) and O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) or 18F\]-fluorocholine (FCH) PET/CTthe FCH allows to improve the location of a active metabolic tumor and its impact on the ideal choice of sampling biopsy.
* To underline the differences and similarities between MRS and 18F\]-fluorocholine PET / CT in the assessment of metabolism of the choline. To establish the diagnosis value of both methods, separately and in combination.
* To determine which examinations are useful and complementary for the diagnosis and the management of gliomes.

FET combined with MRS may be a powerful, widely applicable new method to improve the diagnosis of cerebral gliomas. The extent to which FCH and MRS provide similar information is not known precisely and this study will establish their respective diagnostic value in differentiating tumoral from non-tumoral tissue.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of intracerebral glioma on MR
* Men of women
* Age \>18, no upper limit as long as a biopsy or intervention is foreseen

Exclusion Criteria:

* Need of rapid intervention in \<2 weeks
* Previous neurosurgical intervention (biopsy, shunt, etc.) or any other cerebral treatment
A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells

The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years, of either gender
* Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
* Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC distribution width(RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), creatinine). Values outside of normal reference range thought not to be clinically significant may be allowed with a protocol exception.
* Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects
* Negative blood donor screening test panel for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV), Syphilis, and west nile virus (WNV) (if available)
* Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
* Meet or exceed American Association of Blood Banks (AABB) guidelines for blood donation (with the exception of travel deferrals).
* Signed and dated informed consent form

Exclusion Criteria:

* • Clinically significant acute or chronic disease (as determined by the Investigator)

  * History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies, or autoimmune disease
  * History of congenital red cell disorders including glucose 6 phosphate dehydrogenase (G-6PD) deficiency
  * Serum ferritin \<12 ng/mL
  * Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at study entry
  * Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the past 28 days
  * Treatment with any medication known to affect RBC viability
  * Pregnant or nursing female
  * Male subjects or female subjects of childbearing potential not using effective contraception
  * Participation in another clinical study currently or within the past 28 days
  * Prior exposure to S 303 treated RBCs
  * Pre-existing antibody specific to S 303 treated RBCs
MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma

This research study is being conducted to determine the effects of PEGPH20 plus chemotherapy treatment on the MRI characteristics of locally advanced pancreatic cancer patient tumors. Subjects will received Gemcitabine, Abraxane and PEGPH20.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. Capable of giving informed consent.
3. Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies
4. Aged ≥ 18 years.
5. borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.
6. ECOG PS of 0 or 1
7. Must have adequate organ and hematopoietic function
8. Female and Males must use an approved contraceptive method

Exclusion Criteria:

1. Received prior therapy for pancreatic adenocarcinoma
2. History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
3. Contraindication to therapeutic anticoagulation or heparin
4. Intolerance to dexamethasone
5. Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
6. Known or suspected brain metastasis
7. Significant cardiovascular disease such as current New York Heart Associate Class III/IV heart failure, myocardial infarction or stroke within 6 months prior to enrollment
8. A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
9. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint
10. Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
11. Subjects may not receive concomitant anticancer agents or radiation.
12. Female subjects who are pregnant or nursing
13. Pre-existing peripheral neuropathy \> CTCAE Grade 2.
14. Known allergy to hyaluronidase
15. Current use of megestrol acetate (use within 10 days of Day 1)
16. Inability to comply with study and follow-up procedures as judged by the Investigator