cyrilzakka/clinical-trials huggingface dataset:
Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease

Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.The pathogenesis of COPD is still unclear, so there is no specific treatment at present .COPD was considered to be the result of a combination of environmental and genetic factors. Genetic factors play an important role in the acute exacerbation of COPD.Therefore, it is an urgent need to explore the heterogeneity of COPD phenotype from the perspective of genes and to seek individualized prevention and treatment programs.This study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of COPD, thereby improving the prognosis of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic obstructive pulmonary disease
* aged \>= 40 years

Exclusion Criteria:

* spirometry can not be completed because of various reasons
* asthma
* pulmonary embolism
* lung cancer
* sequelae of tuberculosis
* extensive bronchiectasis
* interstitial lung disease
* left cardiac insufficiency
A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001

To investigate the dosage of RRx-001 by the subcutaneous route.

This is a phase I, open-label, dose-escalation study of RRx-001. Subjects will receive RRx-001 administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.

The purpose of the study is to extend the dosage options for RRx-001 since faster subcutaneous (SC) administration may increase convenience versus the traditional IV method. The study also will also measure the mean concentrations of an RRx-001 metabolite in the blood (pharmacokinetics; PK) versus the IV formulation.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* ECOG (performance) status of 0, 1 or 2.
* Histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. Subjects with curative treatment options are not eligible for the protocol.
* No active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and anti-androgens such as; Flutamide, Dutasteride, and Finasteride).
* Adequate organ and bone marrow function.
* Male and female subjects of childbearing potential must agree to use contraception.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Use of anti-coagulant therapy.
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

This study consist of a double-blind, placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive either ofatumumab or placebo in addition to their background methotrexate treatment. Patients who complete the 24 week Double-blind Period without receiving rescue DMARD treatment will then be eligible to proceed into the 120 week Open-label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity.

Patients who have completed the Open-label Period or have been withdrawn will then enter a maximum 2 year Follow-up Period, or until there B-cells return to normal or to baseline levels, whichever occurs earlier

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Active disease at the time of screening as defined by:

  ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);
* Inadequate response to previous or current TNF-alpha antagonist treatment;
* Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion Criteria:

* Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA;
* Previous exposure to biologic anti-rheumatic therapies, including investigational compounds;
* Exposure to TNF-alpha antagonist treatment \< 12 weeks prior to visit 2;
* Chronic or ongoing active infectious disease requiring systemic treatment;
* Clinically significant cardiac disease; History of significant cerebrovascular disease;
* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease;
* Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR;
* Serum IgG \< lower limit of normal;
* Breast feeding women or women with a positive pregnancy test at screening;
* Current participation in any other interventional clinical study;
* Patients known or suspected of not being able to comply with a study protocol.
Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP

The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.

Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing ERCP with primary intent to cannulate the bile duct
2. Written informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Non-naive papilla (previous sphincterotomy)
3. Surgically altered anatomy
4. Known/suspected pancreas divisum
5. Suspected SOD/biliary manometry
6. Prior ERCP/stent within 3 months
7. ERCP performed in the Operating Room or at Duke North
8. Pregnancy/breast-feeding
AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* over 18

Exclusion Criteria:

* on aspirin in prior week
* medical history of platelet disorders
* contraindications to aspirin
The Effect of Hyperbaric Oxygen Therapy on Circulating Hematopoietic Stem Cell Population

Hematopoietic stem cells (HSCs), which govern the production of all blood lineages, transition through a series of functional states characterized by expansion during fetal development, functional quiescence in adulthood, and decline upon aging.

Although research on aging has for a long time been relatively descriptive, much progress has been made in the past decade to uncover the molecular drivers of biological aging. One such drivers relates to stem cell exhaustion.

The amount and the function of HSCs decline in humans along aging. This decline is characterized by different changes such as signaling, epigenetic, cell surface markers etc. Various studies have been conducted to identify HSCs surface markers using flow cytometry.

Exposure to HBOT induce stem cells proliferation mobilization of stem progenitor cells (SPCs) in both animal and humans studies, and the number of SPCs remain elevated in blood over the course of 20 HBOT .

Additionally, Heyboer et al have found dose response curve between the HBOT protocol and circulating CD34+ and CD45-dim (stem cells potential markers): increasing the treatment pressure from 2.0 ATA to 2.5 ATA increased the concentration of circulating stem cells.

The aim of the current study is to evaluate the effect of HBOT on circulating hematopoietic stem cells, in the peripheral blood of patients who are candidate for HBOT.


Eligibility Criteria:
Inclusion Criteria:

* The study will include patients aged 20-80 who are intendent to start HBOT for other indication that are willing to give blood samples for measurements of circulating stem cells.

Exclusion Criteria:

1. Active or recent infection within the last month
2. Active malignancy.
3. History of hematopoietic disease
4. Low B12 or iron levels
5. Inability to sign the informed consent form
6. Leucocytes ˂4000 or ˃10,000
Effects of Black Tea on Type 2 Diabetes

The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

* Intake of antioxidant supplements during previous six months
Clinical Echography in Emergency Prognostic Evaluation of Pulmonary Embolism: ECU -EP Study.

Pulmonary Embolism (PE) is a frequent disease, the third cause of cardiovascular death after stroke and myocardial infarction. According to European guidelines of European Society of Cardiology (ESC) and of European Respiratory Society (ERS), the prognostic stratification of PE severity is mandatory as soon as PE is diagnosed. This stratification includes the hemodynamic status, and specific tools : the assessment of the sPESI score, and the evaluation of PE's impact on right ventricle (RV) : increased biomarkers (troponin, BNP) and right ventricle/left ventricle (RV/LV) ratio.

the RV/LV ration may be evaluated ideally by transthoracic echo (TTE), or by CT scan. Unfortunately, only 10% of patients with PE are evaluated with TTE by a cardiologist in the initial time of PE diagnosis. Hence, the CT scan is the most frequent way to assess RV/LV ratio. However, CT is not possible for all patients (patients with contra-indication) or may have difficulties to provide a clear assessment because of technical issues.

Then, there is a need for morphological evaluation of RV as soon as PE is diagnosed, in every clinical setting. The improvement in technologies allowed the development of clinical echography (CE) in emergency departments.

CE is already available, non-invasive, less expansive, and may be a good way to assess RV/LV ratio in patients with PE diagnosed in emergency departments.

The investigators propose a prospective, multicenter study to assess the sensitivity of CE in patients with PE, compared to CT scan to detect RV/LV ≥0.9.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with pulmonary embolism confirmed
* Simplified Pulmonary Embolism Severity Index (sPESI) ≥ 1

Exclusion Criteria:

* Contra-indication to CT scanner
* Patients with high-risk pulmonary embolism (shock, hypotension)
* Simplified Pulmonary Embolism Severity Index (sPESI) =0
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.

For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done.

After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time.

The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* pain for more than 6 months，poor response to the conservative treatments
* Sonography showed plantar fasciitia\>4.0mm)

Exclusion Criteria:

* Acute infection of soft tissue/bone
* Malignant primary disease
* Blood coagulation disorders
* Pregnancy
* Patients with pacemaker
* foot deformity
Algometer and Category II Pelvic Blocking and Cranial Protocol

The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at specific points before and after each treatment of pelvic blocking with or without cranial adjusting.


Eligibility Criteria:
Inclusion Criteria:

* Logan student, staff or faculty
* Age 18 - 60
* No chiropractic adjustment 2 weeks prior to beginning the study
* Show the DeJarnette Category II indicators

Exclusion Criteria:

* Previous lower extremity, first rib and spine injury, surgery
* Local infection, injury or other malignancy affecting the lower extremity and the nervous system
* Unstable joints of the lower extremity and/or first rib and/or spine
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect the nervous system
* Contraindication to DeJarnette Category II Pelvis Blocking
* Pregnancy
* Significant lower lumbar involvement
* Diabetes, shortness of breath on light physical activity, cardiovascular disease
* Numbness and/or tingling in the lower extremities
Effects of Qigong, Tai Chi and Yoga Practice in Older Adults

The purpose of this study is to compare the effects of an 8-week intervention using YiRen Qigong, Tai Chi or Hatha yoga in older adults (age 70 and above) residing at a Gencare senior living facility. Outcome measures completed at the beginning and end of each intervention period will be blood pressure, heart rate, perceived quality of life (PQOL)and a symptoms questionnaire (SF-36), ability and speed of walking 20 feet (for ambulatory participants), and neck and arm range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Be a resident of a Gencare Senior Living facility in Granite Falls, Lynnwood, Renton, Ballard and Lake City, WA
* Be at least 70 years of age
* Be willing to participate in the tai chi, qi gong and/or yoga classes
* Willing to complete study-related outcomes assessments

Exclusion Criteria:

* Not medically able to participate in the mild level of activity involved in the 3 interventions as determined by the resident's physician
* Unable to complete study questionnaires or study procedures at screening
Permeability Enhancement to Reduce Chronic Inflammation

Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis treatment for ≥ 3 months
* Dialysis 3x weekly
* Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
* Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
* CRP \> 5mg/L at least once within 12 weeks before inclusion
* Age \> 18 and \< 99 Years
* Ability to give written informed consent

Exclusion Criteria:

* Missing informed consent form
* Clinically manifested infection or current CRP-value \> 50mg/L
* Serum albumin \< 35g/L
* Intake of immune suppressive medication
* Pregnancy or lactation
* Participation in a different study
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement

This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the COC total hip replacement system)

Up to five (5) sites will participate. These sites participated in the IDE study and will continue subject follow-up.

Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit.

If a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were previously enrolled in the COC 36 IDE study;
* Individuals who are willing and able to provide informed patient consent for participation in the study;
* Individuals who are willing and able to return for follow-up as specified by the study protocol; and
* Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.

Exclusion Criteria:

* In the opinion of the Investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations.
* Any component of the primary total hip was previously revised.
Effect of Transcranial Direct Current Stimulation (tDCS) on the Excitability of the Diaphragmatic Primary Motor Cortex

Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to modulate cerebral cortex excitability. It was shown that anodal stimulation increases cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the corticodiaphragmatic pathways. This preliminary study aims to test and validate the modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed before and after applications of three different modalities of tDCS (anodal, cathodal and placebo).

We therefore expect to observe a significant increase of the mean values of the right hemidiaphragm's MEP's amplitudes after application of anodal tDCS compared to the baseline MEP obtained before this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Right handed,
* Healthy male volunteers
* Aged ≥ 18 and ≤ 35 years
* No history of neurological or respiratory disease
* BMI (body mass index \< 30)

Exclusion Criteria:

* Female sex
* Vulnerable people as defined in the provisions relating to biomedical researches and described in the Code of Public Health.
* Recent or ongoing use of antibiotic drugs, antidepressants or psychotropic drugs.
* Recent hospitalization (within 3 months).
* No affiliation to a social security system.