cyrilzakka/clinical-trials huggingface dataset:
Chiropractic Management of Chronic Lower Back Pain in Older Adults

The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.

The identification of alternative safe and effective interventions for chronic lower back pain in the elderly is critical in view of its high prevalence, negative impact on quality of life and the treatment risks associated with chronic medication use. This is particularly germane to the veteran population, with a prevalence of lower back pain in excess of 40%. In 1998, published guidelines from the American Geriatric Society listed chiropractic management among the non-pharmacologic strategies for treating chronic pain symptoms in older adults. A recent study showed that a substantial number of older patients who received chiropractic care were less likely to be hospitalized, less likely to have used a nursing home, more likely to report a better health status, more likely to exercise vigorously and more likely to be mobile in the community. Patients undergoing chiropractic care have also reported greater satisfaction as compared to standard medical care. Despite the general clinical acceptance of chiropractic care and satisfaction with chiropractic services, evidence on the potential benefit and safety of chiropractic management of lower back pain in older adults is lacking. The purpose of this study is to evaluate the effectiveness of chiropractic management in older adults with chronic lower back pain, by comparing spinal manipulation to a sham intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Pain greater than three months in duration
2. Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
3. Pain elicited upon deep palpation of the lumbar erector spinae musculature 4) Pain that can be either exacerbated or relieved by varying body position

Exclusion Criteria:

1. Patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture
2. Patient will be excluded if they have undergone a course of previous chiropractic care
3. Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected.

   * The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.
BioFreedom Pharmacokinetic Study

The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.

The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.

The study will include up to 20 CAD patients following implantation of the commercially available BioFreedomTM SS stent in a single Spanish center. Venous blood samples will be taken up to 72 hours after implantation. Whole blood concentrations of Biolimus A9TM and its active metabolites sirolimus and everolimus will be determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. Mean, median and range of PK variables (Cmax, Tmax, and AUC) together with a Summary Statistics table will be generated as part of the PK analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction;
3. Presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents;
4. Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm;

Exclusion Criteria:

1. Individual is pregnant, nursing or planning to be pregnant;
2. Patient presents with STEMI;
3. Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material;
4. Inability to provide informed consent;
5. Currently participating in another trial;
6. Treatment with any DES within the previous 6 months;
7. Patient requires a stent \<2.25mm;
8. Patient requires a stent \>4.0mm;
9. Patient receives a non-study DES stent during the index procedure;
10. Use of a drug coated balloon planned at the index procedure;
11. Systemic use of a -limus drug.
Same-Day Discharge After Coronary Percutaneous Transluminal Coronary Angioplasty (PTCA)

Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral approach.

The feasibility and safety of same day discharge post PCI will be examined. Study data will be compared to national registries and national or regional databases of PCI in Troponin negative patients with overnight stay. As part of the registry we will also assess compliance with dual antiplatelet therapy at six months and at 1 year and will record any reasons for premature discontinuation as well as any associated adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for catheterization/coronary angiography
2. Undergoing diagnostic coronary angiography to define the coronary anatomy with the intent for revascularization (ad-hoc PCI) or planned PCI to define the coronary anatomy with the intent for revascularization due to one of the following:

   1. exertional or rest chest pain (or angina equivalent)
   2. abnormal Exercise Stress Test
   3. abnormal nuclear tests
   4. abnormal pharmacologic or stress echocardiogram, or pharmacologic MRI
   5. abnormal EKGs
   6. abnormal Calcium scores
   7. abnormal coronary CT angiogram
3. Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

1. ACS (STEMI, UA/NSTEMI)
2. Positive Troponin I per local laboratory standards
3. Known EF\<30%
4. GFR\<50% (calculation using the IDMS-Traceable MDRD study equation
5. Dye Allergy that unable to be safely premedicated
6. Known current or history of bleeding diathesis
7. Current or anticipated treatment with warfarin, oral factor Xa inhibitor, oral direct thrombin inhibitor, LMWH, or TNK
8. Known platelet count \<100,000/mm³ or known INR \>1.5 at time of enrollment
9. Hgb \<10 g/dL and/or Hct \< 30%
10. Residence \>60 minutes from the hospital
11. Reliable caregiver not available for home post PCI recovery
12. Participation in another study that would require hospital procedures or test post PCI prior to discharge
13. Inability or unwillingness to consent for study, follow up procedures and Authorization for use of PHI
14. Physician clinical determination participant is not suitable for study participation
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
* Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
* Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
* Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.

Exclusion Criteria:

* Participant met criteria for removal from therapy in her respective Pivotal Study.
* Participant is planning a pregnancy within the next 18 months.
* Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
* Participant has any new medical conditions that may be unsuitable for participation.
* Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* Absolute number of T4 cells 100-300 cells/mm3.
* Given informed consent.
* Zidovudine (AZT) therapy for 6 months prior to study entry.
* At least one of the listed HIV-related clinical symptoms or opportunistic infections:
* weight loss \> 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis \> 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Evidence of AIDS.
* Intercurrent acute medical disorder.

Concurrent Medication:

Excluded:

* Chemotherapy for Kaposi's sarcoma (KS).
* Aspirin.
* Non-steroidal anti-inflammatory drugs.

Patients with the following are excluded:

* Inability to return for treatment and evaluation for 12 months.
* Intercurrent acute medical disorder.
* Evidence of AIDS.
* Receiving chemotherapy for Kaposi's sarcoma (KS).
* Unwilling or unable to give informed consent.

Required:

* Zidovudine (AZT).

Required at least 6 months prior to study entry:

* Zidovudine (AZT).

Active drug abuse.
Metabolic Study of Sleep Apnea in Men and Women

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.

Obesity is a major risk factor for obstructive sleep apnea (OSA), a condition characterized by repetitive respiratory disturbances, intermittent hypoxia, sleep fragmentation by frequent microarousals and low amounts of deep slow wave sleep (SWS). Today, more than 10 million American women suffer from OSA. OSA has been identified as an independent risk factor for the metabolic syndrome. Because OSA is more prevalent in men than in women, a disproportionate number of studies of OSA and its consequences have been conducted in men. Thus, OSA has been characterized as a disorder associated with gender-based health care inequity. Recent evidence, including data from our group, suggests that reduced amounts and intensity of SWS (i.e. slow-wave activity \[SWA\]) may play a pivotal role in the development of metabolic and cardiovascular disturbances in obese men and women, particularly those with OSA. This project will focus on sex differences in SWA and their relationship with daytime sleepiness and metabolic vulnerability in obese men and women with and without OSA. We propose to simultaneously characterize: 1. sleep-wake regulation; 2. measures of diabetes risk; 3. measures of cardiovascular risk; and 4. profiles of sex steroids, cortisol and adipokines in a. obese men without OSA, b. obese men with OSA before and after treatment with continuous positive airway pressure (CPAP), c. obese pre-menopausal women without OSA, and d. obese pre-menopausal women with OSA before and after CPAP treatment. The completion of these interdisciplinary studies will provide a unique data set contrasting in obese women versus obese men the relationships between sleep and the metabolic syndrome, OSA and the metabolic syndrome and the impact of CPAP treatment on the metabolic syndrome. This work will provide important insights regarding the pathophysiology of OSA and its adverse consequences in obese men and women, and the basis for the development of effective sex-specific prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI of at least 30 kg/m2)

Exclusion Criteria:

* Clinically significant depression
* Positive pregnancy test
* Diagnosis of diabetes mellitus
* Hypertension (systolic \> 140 mmHg and/or diastolic \> 90 mmHg) not well-controlled on stable medication with either ACE inhibitors or diuretics
* Habitual alcohol use
* Excessive caffeine intake of more than 300 mg/day
* Hemoglobin \< 11g/dL and/or hematocrit \< 33%
* Systemic illnesses, including heart, renal, liver, or malignant disease
* Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
* Travel across time zones during the 4 weeks prior to starting the study
* Irregular sleeping habits (including shift work)
Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio \<=0.15, or total PSA 10-20 ng/ml)
* PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
* No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Exclusion Criteria:

* Previous prostate biopsies
* Previous prostate surgery
* Contraindication for MRI (such as pacemaker or inner ear implant)
* Claustrophobia
* Estimated glomerular filtration rate (eGFR) \<40 ml/min
* Suspected clinical T3-T4 prostate cancer based on digital rectal examination
* Contraindication for transrectal ultrasound-guided prostate biopsies
* body mass index \>30
Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction

On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.

This is an open label placebo-controlled randomized clinical trial to assess the effect of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.

Inclusion criteria: age \> 18 yrs, hemodialytic treatment from at least 6 months (3 times for week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance \<5 ml/min, urine output\<500 ml/die.

Exclusion criteria: neoplastic diseases, chronic autoimmune diseases, lack of consent, solid organ or bone marrow transplantation.

Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as routine hemodepurative technique for end stage renal disease patients. Patients were evaluated for adverse reaction at each dialysis section; investigators recorded intra and extra-dialytic adverse events.

Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15 patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany) for 9 months.

Efficacy Assessments:

Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9 months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months. changes in RNA content of circulating microvesicles (at 3 and 6 months)

Study Duration: 9 months

Statistical Methods: Data have been analyzed according to an intention-to-treat approach. Statistical analysis was performed using the unpaired Student t -test, ANOVA, or Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (Qb) ≥250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance \<5 ml/min, urine output \<500 ml/die.

Exclusion Criteria:

* neoplastic diseases, autoimmune diseases, solid organ or bone marrow transplantation
Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock

B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis related cardiac dysfunction and volume overload in critical ill patients. It is also a marker associated with prognosis in patients with severe sepsis and septic shock. However, the clinical utility of BNP level in management of early severe sepsis and septic shock over the first 48 hours is not clear. Besides, Lactate represents as a maker of tissue hypoperfusion, which has been used as a guide therapy for sepsis patients and high serum lactate level is independently associated with mortality in severe sepsis. Today, in management of early severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy (EGDT) with achieving the central venous pressure (CVP) level 8-12 mmHg by fluid support first, then targeting the next goal to maintain mean airway pressure (MAP) at least 65 mmHg by vasopressor agent (ie, Norepinephrine) and finally keeping central venous oxyhemoglobin saturation (ScvO2) \> 70% via optimal Hct \> 30% and dobutamine usage within first 6 hours of emergency department admission. However, the role of BNP and lactate in patients with severe sepsis and septic shock with or without myocardial dysfunction under EGDT management are not clear.

The investigators will conduct a prospective observational study to investigate the change of BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT management, their association of cardiac dysfunction and their role in predicting various clinical outcome. The investigators also want to see if BNP and lactate could be useful tools to guide the adjustment of optimal fluid supply and the timing of inotropic agent intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Severe sepsis with or without septic shock

Exclusion Criteria:

1. Previous known heart failure or cardiomyopathy history
2. Acute coronary syndrome
3. Clinical pulmonary hypertension with various cause (iPAH, congenital heart disease, CTEPH, COPD with cor pulmonale)
4. Patients with acute pulmonary embolism
5. Chronic Af with LVH
6. Acute cerebral vascular event
7. Respiratory failure with high PEEP \> 10 cmH2O)
8. Various cancer with distant metastasis
9. Patients with Bosmin therapy
10. Patients received CPR (IHCA or OHCA)
11. Massive GI bleeding or hypovolemic shock
12. Pregnancy
13. Contraindication to central venous catheterization
14. Drug overdose
15. Burn injury, trauma patients
16. A requirement for immediate surgery
17. Liver cirrhosis child C
Metabolic Availability of Lysine From Rice

The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.

The investigators objective is to determine the metabolic availability (MA) of lysine in cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult males (18 to 50years old)

Exclusion Criteria:

* A history of recent weight loss or illness
* Use of any medication at the time of entry into the study.
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
* Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
* Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
* Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung

Exclusion Criteria:

* Participants who have had previous chemotherapy for adenocarcinoma of the lung
* Prior surgery with curative intent for adenocarcinoma of the lung
* Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)