cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females age less than or equal to 18
* TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by:

  * a history of lower extremity peripheral vascular surgery for obstructive atherosclerotic disease, or
  * a history of lower extremity peripheral arterial angioplasty for obstructive atherosclerotic disease, or
  * a history of lower extremity amputation secondary to atherosclerotic disease, or
  * an ABI \<0.90 within the previous 90 days, or
  * a history of claudication in patients with documented coronary artery disease (i.e., history of myocardial infarction, coronary revascularization, or coronary angiography demonstrating at least one obstructive coronary lesion with a 50% or greater stenosis).

Exclusion Criteria:

* Women of childbearing age who do not agree to utilize protocol approved contraceptive methods.
* Average pre-dose SBP \< 100 or DBP \< 60.
* Patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases.
* Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last 30 days.
The Use of Local Hemostatic in Patients With Large Incisional Hernias

Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock

Design of a simple blind randomized controlled trial study. The total number of subjects was 66. In the main group (A) - 33, in the other group (B) - 33. Operation - sublay retromuscular using prolene mesh implant. In group A Hemoblock 15 ml in the retromuscular and 15 ml in the subcutaneous spaces were used. Wounds were drained by vacuum-suction drainage. Postoperative monitoring of early ultrasound examinations on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal.

In group B were used a standard intervention (sublay retromuscular).

Eligibility Criteria:
Inclusion Criteria:

1. ASA I, II, III
2. the absence of oncological pathology
3. consent to participate in the study
4. Large incisional hernia (hernial defect ≥10 cm in diameter and/or area of hernial defect ≥100 cm2) according to the classification of EHS, 2009 (W3); age 25-75 years

Exclusion Criteria:

1. age older than 75 years
2. decompensated concomitant pathology, ASA≥IV
3. patient refusal to participate in the study
Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants

The purpose of this study is to assess the safety, tolerability and PK of Leritrelvir in elder participants


Eligibility Criteria:
Inclusion Criteria:

1. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI\<28 kg/m2,BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
4. Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃

   Young Participants Only:
5. Participant must be ≥18 to ≤45 years old

   Elder Participants Only:
6. Participant must be ≥65 years old

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies)
2. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
3. Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection),within 2 weeks before screening;
4. Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles

   Young Participants Only:
5. Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
6. Physical examination, vital signs, laboratory tests (blood routine+CRP, urine routine + urine sediment, blood biochemistry, coagulation function, infectious disease test, glycosylated hemoglobin test), 12-lead electrocardiogram, chest CT, abdominal color Doppler ultrasound and other examinations have clinical significance

   Elder Participants Only:
7. Participants had a history of or evidence of cardiovascular disease before screening，including uncontrolled hypertension, orthostatic hypotension, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months before screening, or history of tachycardia/bradycardia requiring medical treatment, and degree II-III atrioventricular block.
8. Participants who had other serious organ-systemic serious diseases at screening, including but not limited to respiratory, neurologic, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardiocerebrovascular diseases, and was judged by the investigator to be ineligible for participation in the trial
Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with the study procedures and duration requirements
* 18 years of age or older
* Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Undergone an amputation of any upper extremity
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
* Subjects with body hair density which prevents adequate application of device electrodes
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease

The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).

The primary objectives of this study are:

1. To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
2. To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \& area measurements \& plaque volume.
3. To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
4. To evaluate the ability of DSCT to identify \& measure lesion remodeling compared to gray-scale IVUS.
5. To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females
* \> / = 18 years of age
* Scheduled for coronary angiography

Exclusion Criteria:

* Acute ST-elevation myocardial infarction within last 72 hours
* Current congestive heart failure
* Current cardiogenic shock
* Unstable clinical condition
* Known cardiomyopathy (EF \< 30%)
* Creatinine \>1.5 mg/dL
* Definite allergy to iodinated contrast media
* Current participation in an investigational drug or device research study
* HR \> 65 and contraindications to the administration of beta blockers

Exclusion criteria assessed during catheterization procedure

* PCI of native coronary vessel not performed
* Left main stenosis \> 50%
* Any vessel contraindicated for IVUS imaging
* Any lesion contraindicated for IVUS imaging
* Inability to pass IVUS catheter
* PCI of bifurcation lesion
Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL

The use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+ ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with low-intensity chemotherapy is currently initiated within the EWALL centers.

3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01 study it could be anticipated that 50 to 100 patients aged more than 55 years will be diagnosed during this 6 months period of time. In addition, all the EWALL centers are not participating to the EWALL-PH-02 study and thus these centers could be offered to treat patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be defined in order to collect the data of the patients treated following the EWALL-PH imatinib study. The main recommendation is to follow as close as possible the procedures of the EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set. This imatinib treated cohort of patients would be of particular importance in order to better define the potential benefit of using one TKI compared to one other. From the end of the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were treated following the common backbone schedule in combination with imatinib or others TKI. Patients not included in clinical trials for other reasons were also offered a treatment with the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory retrospective and prospective is to describe the efficacy and the tolerance of the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 55 years
2. Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
3. Not included in a prospective clinical trial
4. Treatment with the combination of tyrosine kinase inhibitors and low dose chemotherapy as recommended by the EWALL group (EWALL backbone).

Exclusion Criteria:

1. Patients deceded and having previously refused data collection.
Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.

OBJECTIVES:

* Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).
* Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.

OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.

Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior registration on protocol CALGB-9665
* Diagnosed with acute myeloid leukemia (AML)
* Treated on a CALGB AML treatment protocol
* Diagnostic bone marrow or blood specimen available

PATIENT CHARACTERISTICS:

Age:

* 15 and over
Individualized Response to Vitamin D Treatment Study

The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment.

This study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.


Eligibility Criteria:
Inclusion Criteria:

1,600 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) study who are returning for their scheduled 6th MESA study visit.

Participants will be recruited from four field centers: Wake Forest University, Winston-Salem, NC; Columbia University, New York, NY; Northwestern University, Evanston, IL; and Johns Hopkins University, Baltimore, MD.

Exclusion Criteria:

1. Current use of \>1,000 international units (IU) of cholecalciferol daily
2. Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)
3. Known history of allergy or adverse reaction to vitamin D treatment
4. Known clinical history of primary hyperparathyroidism
5. Known clinical history of kidney stones within the previous 5 years
6. Current participation in another interventional study
7. Inability to provide written informed consent
Biomarkers of Antidepressant Resistance

According to the WHO, major depressive disorders have become the second worldwide cause of disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).

Establishing a cerebral molecular signature of depression is not feasible in humans (need for cerebral samples). The alternative is to use peripheral biological samples (blood, urine, saliva).

Metabolomic is the integrated and quantitative study of all the metabolites of a biological system. This aims to define the metabolic status of an organism for a particular condition.

Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.) and are detected by:

* liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),
* proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies have become important diagnostic criteria, measured objectively and evaluated as indicators of a normal or pathological state, or even predictors of treatment efficacy.

This approach allows the discovery of biomarkers that best describe the status of a disease for better understanding and are usable in a context of individualized medicine, with effects on clinical practice and management.


Eligibility Criteria:
Inclusion Criteria:

* between 18-60 years-old
* major depressive disorder, confirmed by Mini International Neuropsychiatric Interview (MINI)
* no bipolar disorder or schizophrenia, confirmed by MINI
* no neurological dementia disease
* able to perform olfactive tests, i.e. no anosmia and/or allergy to odors
* score MADRS (Montgomery AsbergDepression Rating Scale) \>20
* no antidepressant treatment during 14 days before inclusion
* informed written consent
* affiliation to a social security system

Exclusion Criteria:

* patient who don't want any antidepressant treatment for this depressive episode
* legal incapacity and/or any circumstances making the person unable to understand the trial features, purposes or consequences
* participating to drug clinical study or in exclusion period of clinical study because of previous participation
* pregnant woman
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia

Patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. Due to unclear etiology, there is a lack of specific treatment methods. The aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.

We plan to enroll patients with pudendal neuralgia .Pre-treatment, we collected data including pain assessment, anxiety, depression, catastrophizing, and pain sensitivity scales. Treatment involved ultrasound-guided pudendal nerve pulsed radiofrequency and X-ray-guided ganglion impar block. The Patient Global Impression of Change (PGIC) and Numeric Rating Scale (NRS) were used as the main observation indicators to evaluate the treatment effect at 1, 2, 3, and 6 months postoperatively, followed by correlation analysis with the scores of relevant scales.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years old;
2. Diagnosis of pudendal neuralgia meets the Nantes criteria. essential criteria include the following：1）Pain in the territory of the pudendal nerve；2） Pain is predominantly experienced while sitting；3) The pain does not wake the patient at night；4）Pain with no objective sensory impairment；5）Pain relieved by diagnostic pudendal nerve block；
3. Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects.
4. Capable of signing informed consent form.

Exclusion Criteria:

1. Pain caused by pelvic malignant diseases or autoimmune diseases;
2. Pain caused by pelvic surgery;
3. Taking anticoagulant drugs or having abnormal coagulation function;
4. Pregnancy;
5. Systemic infectious diseases;
6. Inability to complete scale assessments.
A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects, aged 18 to 45 years (inclusive).
2. Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
3. Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
2. Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
3. Subjects with positive tests for infectious diseases.
4. Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
5. History of using any medication within 2 weeks prior to the first dosing.
6. Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
7. Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
8. Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
9. Female who are pregnant or breastfeeding, or have a positive pregnancy test.
10. Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Hypertension Management Using Telemonitoring

This is a prospective study evaluating the feasibility and safety of remote hypertension management using a central telemonitoring program among patients with elevated blood pressure (BP) at the University of Mississippi Medical Center (UMMC).

Patients with elevated BP, identified by the electronic medical record, will be recruited for study enrollment. Patients will be mailed a telemonitoring kit including an electronic tablet equipped with a wireless BP cuff that transmits measurements directly to the UMMC electronic medical record and monitored by the UMMC Center for Telehealth. Patients will participate in a 6 month intervention period during which they will transmit daily BP recordings with regular contact by a Telehealth nurse coordinator who will provide education and encourage healthy lifestyle habits. Every 2 weeks BP medications will be adjusted according to an evidence-based treatment algorithm managed by the Center for Telehealth pharmacist using a standardized physician-approved protocol. Data analysis will track metrics of study enrollment, study completion, safety, therapeutic intensification, and BP change from baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Patient of UMMC clinician approving the study
3. At least 2 clinic encounters in the past 12 months with systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg

Exclusion Criteria:

1. Stage 4 or 5 chronic kidney disease
2. Systolic heart failure (LVEF \<50%) or major cardiovascular event (MI, stroke) within 3 months
3. Resistant hypertension (prescribed 3 or more antihypertensive medications at target doses) or known secondary cause of hypertension
4. Pregnancy or inability/unwillingness to use birth control for women of child-bearing potential
5. Institutionalized, dementia, limited life expectancy, uncontrolled mental illness, substance abuse, or other conditions that would prohibit ability to perform regular home BP monitoring
The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial

Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.

this study was proposed to evaluate its efficacy in improving accessary lower limb flexibility and reducing functional disability and pain management. To provide evidence about its effectiveness and help with clinical practice, this study aimed to improve patient outcomes in subjects having lumbar disc bulges.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of Disc bulge confirmed by MRI.
* Between 18 and 65 years of age.
* Chronic low back pain from the last 3 months
* A stable treatment environment that allows intervention.
* Ability to understand and follow course directions.
* Willingness to give informed consent

Exclusion Criteria:

* Spondylolisthesis
* Spondylosis
* Vertebral fracture
* Lack of ava
* Further research interventions.
* Unstable medical condition