cyrilzakka/clinical-trials huggingface dataset:
A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated with Percutaneous Ablation and Palliative Radiation Therapy

The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).


Eligibility Criteria:
Inclusion Criteria:

* 1. Skeletal metastasis with localized pain not controlled medically \[recall within last 24 hours of worst pain ≥ 5 using the BPI\]
* 2. Pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). Extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone/tumor interface pain)
* 3. Lesions that are at high-risk of skeletal related events defined as follows:
* a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine
* b. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain
* 4. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review
* 5. No prior targeted radiation therapy or ablation to the index lesion
* 6. ECOG performance status 0-2
* 7. Age ≥ 21 years
* 8. Have signed the current approved informed consent form
* 9. Willing and able to answer follow-up Patient Reported Outcomes (PRO) surveys (e.g., PROMIS®, BPI, COST-FACIT, and OMED) for up to 12 months
* 10. Life expectancy \> 3 months

Exclusion Criteria:

* 1. Any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
* 2. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone \[MIREL Score ≥ 7\]
* 3. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization
* 4. Concurrent participation in other studies that could affect the primary endpoint
* 5. Target tumor causing clinical or imaging evidence of spinal cord compression
Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study

The goal of this observational study is to evaluate whether polygenic risk score (PRS) assessment can help predict the onset of epithelial ovarian cancer in women aged over 18, comparing those with a histologically confirmed diagnosis of epithelial ovarian or fallopian tube cancer (cases) to women with no personal history of ovarian cancer (controls). The main questions it aims to answer are:

* Is there an association between PRS and the presence of epithelial ovarian cancer?
* Can PRS improve the prediction of ovarian cancer risk when adjusted for other clinical factors?

Researchers will compare PRS values between cases and controls to see if higher PRS percentiles are associated with an increased risk of ovarian cancer.

Participants will:

* Complete a questionnaire on socio-economic status, lifestyle, and dietary habits.
* Undergo blood sampling, for the analysis of BRCA1-2, PALB2, RAD51C, RAD51D pathogenic variants.
* Undergo PRS analysis.


Eligibility Criteria:
Inclusion Criteria:

* For cases: women with a first-time diagnosis of histologically confirmed epithelial ovarian or fallopian tube cancer.
* For Controls women with no concomitant or past OC diagnosis.

Exclusion Criteria:

* For both cases and controls: the presence of concurrent malignancies other from OC.
Appendectomy Versus no Appendectomy With Cesarean Section

Women having cesarean section will be divided into two groups - cesarean section alone or cesarean section with appendectomy. The purpose is to see if the appendectomy can be done without adding any complications to the maternal post-operative course. The hypothesis is that there is no increased incidence of wound infection, post-operative morbidity or longer hospital stay associated with elective appendectomy at the time of Cesarean Section.

Even though the incidence of appendicitis has decreased significantly since the advent of antibiotics, the disease process is still quite ubiquitous in many patient populations. The incidence of appendicitis in women over 20 and under 50 years of age is significant. The annual incidence of appendicitis in women aged 17 to 64 years of age is 1.9 per 1000. In the population aged 15 to 19 years of age, the risk of developing appendicitis is 1 in 99 in each year of this 4-year period. Diagnosing appendicitis in pregnancy poses a great challenge for the obstetrician because the appendix is displaced during pregnancy, nausea is common in pregnancy, direct abdominal signs are variable as well. The incidence of proven appendicitis approximates 1 in 1500 deliveries. Maternal and fetal mortality and morbidity are increased when appendicitis is associated with pregnancy, and the risks rise significantly if perforation and peritonitis occur. Fetal loss, which is between 10 and 20% in most reports, is mainly due to preterm labor or intrauterine death, particularly when perforation occurs. There are three main reasons to perform an incidental appendectomy (at the time of cesarean section): To reduce future mortality and morbidity from appendicitis in women of childbearing age; to eliminate undiagnosed incidental pathology in the appendix; and to eliminate the appendix from diagnostic consideration when the patient presents with abdominal or pelvic complaints. There will be 100 subjects taking part in the study. Standard post operative care will be administered with the only difference in the two groups being the operative procedure (appendectomy or no appendectomy).

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years age
* No previous appendectomy
* Adequate pain control for cesarean section
* Able to give informed consent

Exclusion Criteria:

* Previous appendectomy
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)


Eligibility Criteria:
Major Inclusion Criteria:

* Signed informed consent
* Men or women, 18 to 70 years of age
* Historically confirmed diagnosis of UC by endoscopy and histology
* Patients being in clinical and endoscopical remission at baseline
* Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis
* Toxic megacolon or fulminant colitis
* Colon resection
* Malabsorption syndromes
* Celiac disease
* Bleeding hemorrhoids
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding
* History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
* Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
* Any relevant known systemic disease (e.g., AIDS, active tuberculosis)
* Severe co-morbidity substantially reducing life expectancy
* History of cancer in the last five years
* Abnormal hepatic function at screening visit, liver cirrhosis
* Abnormal renal function at screening visit
* Patients with known hypersensitivity to soy
* Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)
* Treatment with steroids (oral, inhalative, or intravenous \[IV\]), cyclosporine or tacrolimus within last 4 weeks prior to randomization
* Treatment with methotrexate within last 6 weeks prior to randomization
* Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization
* Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization
* Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02
* Existing or intended pregnancy or breast-feeding
Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients with Chronic Low Back Pain

The management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care.

Very classically, analgesic treatment of stage I or II is of use, reinforced by the occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care.

Osteopathic treatment is a specific manual diagnostic and therapeutic procedure.

This study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.

The primary objective is to show that the addition of osteopathic treatment to classical medical treatment decreases pain for patients with chronic nonspecific low back pain.

This goal will be evaluated at 3 months by comparing

* the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and
* the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham osteopathic treatment ).

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic non-specific low back pain: degenerative lumbalgia and low back pain unrelated to anatomical lesions that have been evolving for more than 3 months.
* Patient affiliated with a social security scheme or equivalent
* Patient having signed the study informed consent form.

Exclusion Criteria:

* Patient with specific low back pain: patient with one of the following pathologies: degenerative neurological pathology; infectious pathology; fracture vertebral lesion less than 1 year; vertebral osteosynthesis material or canal narrowing.
* Patient following a treatment of the Morphinic or Neuroleptic type.
* Pregnant, breastfeeding or parturient woman
* Patient participating in another clinical study
* Protected patient: Major under some form of guardianship ; Hospitalized without consent
Personalized Behavioral Nutrition Intervention in Older AAs With T2D

The rapid growth rate and unique challenges as a new immigrant group call for a better understanding of the social and health needs of the older Asian Americans (AAs) population. Overwhelming numbers of AAs, a fast-growing first-generation immigrant group, suffer from type 2 diabetes (T2D) and its consequences of poorly controlled blood glucose. For the older AAs, there are higher prevalence rates, worse diabetes control, and higher rates of complications due to limited English proficiency and health literacy. Despite the evidence concerning the effects of dietary interventions on glycemic control by well-controlled feeding studies in mainstream Americans, a lack of clinical trials of culturally tailored interventions often imposes serious barriers to translate and implement such fruitful and innovative approaches in individuals from ethnic minority communities such as AAs.

The proposed study will use a randomized, controlled design with a sample of 60 AAs aged 65 years or older. Metabolomics methodologies will be incorporated into this research to provide a global picture of metabolites' responses to personalized behavioral nutrition (PBN) intervention. The study results will obtain the necessary information to conduct a meaningful community-based clinical trial to test the effectiveness of PBN in improving dietary patterns and glycemic control in older AAs.

This study is designed with two aims:

1. to determine if PBN intervention improves glycemic control, weight control, and metabolites profiles compared with the control group.
2. to identify significant factors that influence the relative effectiveness of PBN and the relative acceptability of PBN.

Eligibility Criteria:
Inclusion Criteria:

1. Self-identified as Asian Americans (Chinese, Korean, or South Asian)
2. Age 65 years or older
3. Residing in the Bexar County area
4. Diagnosed with type 2 diabetes; A1C ≥7.5% within 6 months of screening
5. Expressing a willingness to participate in all aspects of the study over its full course
6. Possession of a smartphone

Exclusion Criteria:

1. Unable to give informed consent
2. People under another diet regime that is different from the ADA recommended diet
3. Physical or mental health conditions that could limit active participation in the study (e.g., severe illness, blindness in both eyes, severe immobility, psychiatric diseases)
4. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
Vascular Lab Resource (VLR) Biorepository

This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

We are proposing a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

The care of subjects with vascular and metabolic diseases is very fragmentary, and they remain underserved clinically and under-studied. We will capitalize on the highly collaborative clinical environment in HVI and other clinical institutes to develop and constantly utilize a vascular biobank.

This protocol will study blood, urine, and/or stool samples and clinical data from subjects with cardiovascular and/or metabolic diseases including: peripheral artery disease, carotid disease, aneurysmal disease, chronic venous disease, thrombosis, lymphedema and lipedema, non-atherosclerotic arterial stenosis (vasculitis, fibromuscular dysplasia, arterial dissection and aneurysmal disease, May-Thurner Syndrome etc.), compressive and spastic disorders (thoracic outlet syndrome, vasospasm). This initiative will allow for the opportunity to explore pathways of thrombosis, inflammation, gut microbiome, alterations in cell signaling, lipid metabolism and other metabolic pathways in vascular diseases. Further, this study will enhance and expand ongoing efforts in the Vascular Lab to collect data for the purpose of quality control and safety. The specimen sample collection will enable biochemical and genetic testing on participants once sufficient numbers are attained.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Subjects capable of providing informed consent document
3. Subjects with diagnosed with or at risk for cardiovascular and metabolic diseases

Exclusion Criteria:

1. Known life expectancy of ≤ 6 months at the time of enrollment
2. Known current pregnancy
3. Severe Anemia (last documented hemoglobin \< 7.0 g/dL)
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
* Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but \<200 mmHg and a MSDBP less than or equal to 114 mmHg following a 3 to 4-week single-blind placebo run-in period
* The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg
* Patients with a mean daytime (8AM - 4PM) SBP \> 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period
* If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion Criteria:

* History of stroke or transient ischemic attack (TIA) within the last one year
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
* Presence of overt proteinuria at screening
* Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
* Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Type I or Type II diabetes requiring insulin
* Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
* Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis

ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.

This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
* Willingness to give consent to take part in the study.
* Aged \>18 years old.
* Healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary TB patients.

Exclusion Criteria:

* Pregnant woman
* A person who has received treatment for active TB or LTBI in the past 24 months
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.

* double-blind, non-inferiority, prospective, parallel group trial.
* Experiment duration: 07 days.
* 02 visits (days 0 and 7).
* Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Consent of the patient or legal guardian;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma);
* Children aged between 2 and 11 years and 11 months (up to 30 kg);
* Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week;
* Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.

Exclusion Criteria:

* Participation in clinical trial in 30 days prior to study entry;
* Patients receiving immunotherapy;
* Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
* Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* Patients who were in use of oral antihistamines or decongestants in the past 15 days;
* Patients who were treated with systemic corticosteroids in the last month;
* Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?

This work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy participants which will not complete the same protocol, but will be monitored for natural changes in same objectives. Group of patients will be instructed to perform a training protocol.

The research within one participant will last a total of 26 weeks from the initial to the final examination and will include control measurements at 6 and 12 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be informed about training protocol.

Eligibility Criteria:
Inclusion Criteria:

* the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
* the patient is in the age group of 18-60 years,
* the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
* the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
* the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).

Exclusion Criteria:

* patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
* patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.