cyrilzakka/clinical-trials huggingface dataset:
Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease

This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.

Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.

Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.

The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.

In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:

* periodic physical examination and blood tests
* non-invasive imaging studies may include echocardiography and magnetic resonance imaging
* electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
* interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias

Eligibility Criteria:
Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to

* acute myocardial infarction or
* ischemic cardiomyopathy with or without previous myocardial infarction or
* dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present)

Exclusion Criteria:

* none, all patients meeting the inclusion criteria will be eligible.
Assessment of Lung Movement With Computed Tomography (CT)

The purpose of this study is to determine whether patient with ILD have altered lung compliance on chest CT before they have macroscopic structural changes on CT.

Interstitial lung disease (ILD) is a group of lung disorders in which the lung tissues become inflamed and then damaged. Idiopathic Pulmonary Fibrosis (IPF) is one of the subtypes of ILD which has characteristic histological and CT features. It is well known that microscopic fibrosis occurs in the lungs of IPF patients well before the structural changes of fibrosis become apparent on CT. By combining sophisticated image analysis with CT scans obtained at full inspiration and full expiration, it may be possible to detect earlier changes of IPF than currently possible by looking at macro structural features alone. With the recent development of new therapeutics for IPF, early detection of the disease and improved monitoring of treatment efficacy will become important. Using CT to assess regional lung compliance has the potential to become an easily translated clinical tool.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ILD: Subjects must have a physician diagnosis of ILD and be in stable pulmonary condition at the time of the CT
* Healthy subjects: Subjects must have no history of pulmonary disease and smoked less than 100 cigarettes in their lifetime

Exclusion Criteria:

* Subjects less than 18 years of age
Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome

This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.

PRIMARY OBJECTIVES:

I. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days.

SECONDARY OBJECTIVES:

I. Assess whether auranofin is well tolerated in this setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive auranofin orally (PO) on day 2.

ARM II: Patients receive placebo PO on day 2.

After completion of study treatment, patients are followed up at 21-28 days.

Eligibility Criteria:
Inclusion Criteria:

* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count (PLT) \>= 100,000/mm\^3
* Creatinine =\< 2 x upper limit of normal (ULN)
* Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 1.5 x ULN
* Total/direct bilirubin =\< 1.5 x ULN
* Alkaline phosphatase =\< 1.5 x ULN
* Hemoglobin \>= 9 mg/dL
* Negative urine or serum pregnancy test performed =\< 7 days prior to registration, for women of childbearing potential only
* Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required
* Scheduled to receive paclitaxel at a dose \>= 70 mg/m\^2 =\< 14 days from randomization
* Ability to complete the questionnaires or to do so with assistance

Exclusion Criteria:

* Pregnant women
* Nursing women
* Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
* History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
* Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
* Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
* Currently receiving immune-modulating therapies
Dietary Patterns and Risk of Cardiovascular Disease

To study, prospectively, the association between dietary patterns and risk of coronary heart disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age 30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75 years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).

DESIGN NARRATIVE:

In the first five years of the study analyses were performed on food consumption data collected through semiquantitative food frequency questionnaires at baseline and during follow-up in the Nurses Health Study and Health Professionals Follow-up Study cohorts. Dietary patterns were derived from the food consumption data using factor analysis, cluster analysis, and dietary indexes (based on prevailing dietary recommendations). In addition, using existing datasets from dietary validation studies in sub-samples of the two cohorts, the reproducibility and validity of dietary patterns defined by factor/cluster analysis and dietary indexes were evaluated. Further, using prospectively collected and stored bloods in the NHS (n-32,826) during 1989-1990 and the HPFS (n-18,000) during 1993-1994, the investigators examined whether observed associations between dietary patterns and CHD were explained by (or mediated through) plasma biochemical measurements (including serum lipids, thrombotic factors, antioxidants, fasting insulin, and homocysteine levels) in a nested case-control design; and they assessed prospectively the relationship between dietary patterns and these biomarkers in the control samples.

The study was renewed in 2005 to apply novel statistical methods (such as confirmatory factor analysis and structural equation modeling) to validate various dietary patterns and examine their associations with risk of type 2 diabetes, cardiovascular disease and total mortality in two large ongoing cohort studies, the Nurses' Health Study (n=121,700) and Health Professionals' Follow-up Study (n=51,529). In addition to evaluating prevailing dietary recommendations, the study will also examine the role of the Mediterranean-type dietary pattern, the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and the Atkins-type diet in predicting health outcomes. Using repeated measurements of diet, the study will examine the impact of changes in eating patterns and diet quality over time on subsequent risk of diabetes, CVD, and total mortality. In addition, it will examine relationships between major dietary patterns and novel plasma biomarkers of inflammation and endothelial function and whether such relationships are mediated through obesity. Finally, the study will test interactions between dietary patterns and individual single nucleotide polymorphisms (SNPs) and haplotypes of several promising candidate genes in the inflammation and endothelial dysfunction pathway on risk of coronary heart disease, including PPARa, PPARy, Adiponectin (AdipoQ), PON1, IL-6, TNF-a, ICAM-1, VCAM-1, E-Selectin, NOS3, ACE gene, and angiotensinogen (ANG) genes.

Eligibility Criteria:
no history of chronic diseases at baseline
Demonstrate Efficacy and Safety of Metastatic Breast Cancer

The purpose of the study is to demonstrate equivalence

Patients will receive CT-P6 or Herceptin every 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Are females
* Have Her 2 over-expression
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Current clinical or radiographic evidence central nervous system (CNS) metastases
* Current Known infection
* Pregnant or nursing mother
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)

multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.

Primary objective: To evaluate the efficacy of 3 different doses of Sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea (OSA) after at least 12 weeks of treatment at target dose

Secondary objectives: To evaluate the effect of 3 different doses of STM after at least 12 weeks of treatment at target dose in patients with moderate to severe OSA on apnea/hypopnea events, hypoxic burden, sleep quality, daytime sleepiness, patient's perception of symptoms and well-being, comorbidity-related outcomes and safety and tolerability of STM

Exploratory objective: To evaluate potential predictive biomarker (eg, blood gas analysis parameters or additional polysomnography \[PSG\] variables) with regard to efficacy

Eligibility Criteria:
Key Inclusion Criteria:

* OSA diagnosis according to the International Classification of Sleep Disorders - Third Edition criteria with an AHI of ≥15 documented by PSG or polygraphy (PG).
* Currently not treated with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) due to patient-reported:
* non-tolerability; and/or
* non-compliance; and/or
* not willing to use CPAP or MAD (treatment-naïve patients)

Key Exclusion Criteria:

* Any OSA treatment within the last 4 weeks prior to screening
* Fulfill criteria for a dominant central sleep apnea syndrome or dominant Cheyne Stokes respiration
* Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movement arousal index (PLMAI) of \>15\*, insomnia, parasomnia or narcolepsy

  * as part of PSG baseline assessment
* Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition
* Clinically relevant craniofacial malformation
* Any upper airway surgery for OSA within the last 12 months prior to baseline
* Patients who underwent an obesity surgery within the last 2 years prior to baseline or patients actively participating in any weight loss treatment program or use of any weight loss medication (prescription or over-the-counter) within 1 month prior to the first PSG night.
Exercise Influence on COVID-19

An observational study is carried out in the university population of the University of Salamanca to know the impact of the COVID-19 pandemic and the influence of physical exercise on the severity of symptoms.

* Investigate the relationship between the regular practice of moderate physical exercise and the severity of the COVID-19 disease in the university community of the University of Salamanca.
* Prepare an epidemiological study of the impact of the pandemic at the University of Salamanca.
* Analyze the influence of the pandemic on the sports habits of the university community.
* The study population will be the entire university community (teaching and research staff, administration and services staff, and students) who will be contacted via email.

Eligibility Criteria:
Inclusion Criteria:

* University of Salamanca population
* Complete the survey

Exclusion Criteria:

* Survey not filled out completely
Relationship Between Gestational Diabetes Mellitus and Inflammatory Adipocytokins in Obese Mothers and Their Newborn at Delivery

ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender.

Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island.

It is planned a conveniance sample of 20 mother-child pairs per group.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Obese women (BMI : 30 kg/m² or more)
* Aged over 18 years
* With single pregnancy
* With alive newborn at 37 weeks of amenorrhea or more
* With informed consent

Exclusion Criteria:

* Smoker
* Treatments by corticoïds or thyroid hormons
* Overt diabetes
* Complicated pregnancy
* Premature delivery threat
Relationship Between Repetitive Negative Thinking and CBT Outcomes

The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic.

The main questions it aims to answer are:

* Whether the repetitive negative thinking can be used to predict i. initial symptom severity, and ii. therapy outcome (measured by change in scores on disorder specific measures).
* Whether change in RTQ mediates change in outcome Participants are sent weekly questionnaires that measure their progress. Within these questionnaires are the RTQ and other disorder-specific measures that we will be analysing.

Researchers may also compare clients with different disorders to see the accuracy the RTQ can predict treatment outcomes for each disorder.

We are looking to examine how repetitive negative thinking (RNT; i.e. rumination and worry), measured by the repetitive thinking questionnaire (RTQ), affects the outcomes of Cognitive Behavioural Therapy (CBT) for anxiety and trauma disorders. Our study will involve looking over data collected from clients who completed treatment at the Centre for Anxiety Disorders and Trauma (CADAT) from 01/01/2022 to 31/03/2024, we will look at data from before they started treatment, whilst in treatment and once they completed treatment. This is an important issue to address as there is little guidance within existing CBT protocols on to how to identify and target RNT during treatment. Evidence also suggests that not only does RNT maintain anxiety disorders, but it can also interfere with therapy outcome. Research has found that patients receiving CBT for PTSD who displayed high-levels of rumination within their early CBT sessions had poorer outcomes in therapy. Our aim is to formally analyse the relationship between scores on the RTQ and both symptom severity and CBT treatment outcome for anxiety disorders. This would help us to test our hypotheses about the relationship (i.e. those with high RNT have poorer treatment outcomes and changes in RNT predict outcome across a range of anxiety and trauma disorders) and provide a basis for augmenting our existing treatments with interventions that specifically target this process.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed a course of CBT treatment at CADAT for one of the following anxiety disorders: OCD, PTSD, Panic Disorder, Health Anxiety, Emetophobia, Specific Phobia, Social Phobia, BDD, GAD, DPD or Hoarding.
* Participants must have completed regular questionnaires throughout their treatment.

Exclusion Criteria:

* Participants who dropped out of treatment
* Participants who did not complete online questionnaires.
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma

Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.

Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.

This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma.

Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.

This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed
* Male or female, age ≥ 21 years
* Previous treatment with TNF antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy
* Secondary treatment failure with up to one previous TNFα antagonist treatment (from the list above)
* Secondary failure of corticosteroid treatment
* Adequate hematologic, hepatic, and renal function
* Written informed consent.

Exclusion Criteria:

* History of primary resistance or intolerance to any TNFα antagonist.
* History of congestive heart failure or current, controlled or uncontrolled
* Women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial
* Men, if no effective contraceptive method was used during the study and for 3 months afterward
* Any prior exposure to Hu5F9-G4 or other CD47 targeting agents
* Previous allogeneic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or need for graft-associated immunosuppression
* Refusal to sign the informed consent
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant.

Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of one of the primary diseases in early or intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia, and myelodysplastic syndrome)
* Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor
* Patients with a Karnofsky Performance Score ≥ 70%

Key Exclusion Criteria:

* Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS)
* Bacterial, viral, or fungal infections
* Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have been tested positive for HIV
* Patients with any concurrent malignancy. Cancer treated with curative intent \< 5 years previously will not be allowed except for patients with resected basal cell carcinoma or treated cervical carcinoma in situ
* Known contraindications to the administration of rabbit immunoglobulin antibodies
* Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products
Task Shifting in the Care for Patients With Hand Osteoarthritis

The main aim in this randomized controlled trial is to improve access to safe and effective care, professional practice and cost-effective utilisation of health care resources by testing if occupational therapist-led care is as effective and safe as rheumatologist-led care for people with hand osteoarthritis.

Hand osteoarthritis is one of the most prevalent musculoskeletal conditions in an adult population, and may have large influences on an individual's function, health related quality of life, and participation in the society. In the absence of disease-modifying interventions, occupational therapy, comprising information, hand exercises, assistive devices and orthoses/splints, is considered as core treatment. In Norway, people with hand osteoarthritis are increasingly referred to consultation by a rheumatologist in specialist health care. At the same time a shortage of rheumatologists nationwide is stressing the healthcare system's capacity, and rheumatologists time should therefore primarily be allocated to patients in which early diagnosis and medical treatment are essential.

The World Health Organization recommend task-shifting as one method of strengthening and expanding the health workforce. Such models rely on other healthcare providers in expanded clinical roles, where physiotherapists, nurses or occupational therapists working in collaboration with physicians and other team members have their own patients for whom they provide health care services.

In this randomized controlled trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist.

Eligibility Criteria:
Inclusion Criteria:

* Hand osteoarthritis diagnosed by physician in primary care, referred for consultation in specialist health care, and ability to communicate in Norwegian.

Exclusion Criteria:

* Exclusion criteria were cognitive or mental impairment, possible inflammatory rheumatic disease (SR\>40 or CRP\>20, or patient confirming having psoriasis during telephone screening).