cyrilzakka/clinical-trials huggingface dataset:
Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy

Pregnant women at a higher risk for pre-eclampsia (PE) should be offered preventive daily treatment with acetylsalicylic acid (ASA) started before 16 weeks of gestation. To select patients at higher risk for PE, multiparametric assessment combining maternal history, biochemical factors and biophysical factors should be used during the first trimester of pregnancy. Multiparametric risk assessments have a detection rate for early-onset PE around 80% at a false positive rate of 10%. Owing to the low prevalence of early-onset and preterm PE, more than 90% of patients considered at high risk, at the first-trimester screening, will not eventually develop PE. Thus, ASA treatment would be innecessary and could be safely discontinued in these patients.

The sFlt-1 to PlGF ratio has a high negative predictive value for PE during the second and third trimester of pregnancy. Thus, it could be used to detect false-positive patients from the first-trimester screening.

This is a multicentric, randomized, open, parallel, controlled, phase III trial, where 1,080 patients under treatment with ASA for being at high risk for preeclampsia from the first-trimester screening, will be candidates to participate. Patients with a sFlt-1/PlGF \<38, from 24 to 27+6 weeks of gestation will be randomized at a 1:1 ratio and allocated to either continue ASA until 36 weeks or to stop ASA treatment.

The main objective of the study is to demonstrate that in patients considered to be at high risk for PE (from the first-trimester screening) and with sFlt-1/PlGF ratio \<38, between 24+0 and 27+6 weeks, the incidence of preterm PE, after cessation of the treatment with ASA, will not be superior to that of the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Gestational age between 24+0 and 27+6 weeks
* Single pregnancy
* High-risk for pre-eclampsia from the first-trimester screening for pre-eclampsia
* ASA treatment started before or at 16+6 weeks of gestation
* Maternal sFlt-1/PlGF ratio at 24+0-27+6 weeks of gestation
* Signed informed consent

Exclusion Criteria:

* Multiple pregnancy
* Dead and/or fetal polymalformation, including also any fetal genetical and/or chromosomic disease.
* Von Willebrand disease.
* ASA intolerance and /or allergy
* Peptic ulcer
* ASA compliance \<50% before inclusion
* Patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion.
* No signature of the informed consent
Effect of Whole Body Vibration on Bone and Fall Related Parameters

The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* community living elderly females \>/=65 years
* live expectation \> 2 years

Exclusion Criteria:

* secondary osteoporosis
* CVD-events including stroke
* participation in other studies
* medication and illness affecting bone metabolism within the last 2 years
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake
ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF

This is a single arm, pre-post, pilot study assessing the feasibility and acceptability of the ALIGN intervention in metastatic adult cancer patients discharging to local area SNFs.

A novel approach for delivering high quality palliative care for cancer patients discharging to a skilled nursing facility (SNF) is critically needed. This investigator plans to test a palliative care social work led intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) that aims to define patient and caregiver goals, facilitate communication between patients and their care teams, and develop a patient-centered plan that accompanies the patient across all future health system transitions. The central hypothesis is that implementation of ALIGN is feasible and acceptable for cancer patients and their caregivers and SNF staff.

Eligibility Criteria:
Inclusion Criteria:

1. Stage II - IV solid tumor malignancy
2. Discharging from an acute care hospital to a SNF in the metro Denver area
3. Decisional capacity to consent
4. English speaking
5. (During COVID requirements) Either internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits (by participant's assessment)

Exclusion Criteria:

1. Discharging with hospice as their goal of care
New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients

The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.

Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 \[IL-18\] and urine neutrophil gelatinase associated lipocalin \[NGAL\]) can predict the outcome measures listed above.

Eligibility Criteria:
Inclusion Criteria:

* First time liver transplant recipient
* Cadaveric or living donor livers

Exclusion Criteria:

* Unconscious patients or patients who cannot give consent
* Pregnant women
* Prisoners
* Patients receiving dialysis before or during liver transplant operation
* Patients receiving simultaneous liver-kidney transplants
Association Between Pococyturia and Pre-eclampsia Severity

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years or more
* single pregnancy
* admission for pre-eclampsia
* patient receiving information and non-opposition to participate

Exclusion Criteria:

* multiple pregnancy
* in utero fetal demise excepted if associated with pre-eclampsia
* antecedent of nephropathy
* fetal malformation, chromosomal anomalies
* inability to understand information provided
* prisoner or under administrative supervision
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility Criteria:
Inclusion:

* Histologically confirmed diagnosis of CML blast phase
* Ph chromosome-positive
* Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
* Patients must have recovered from the side effects of previous CML therapy for blast phase with the exception of hydroxyurea
* Age \>/= 2 years
* Bilirubin \</= 3 x the upper limit of normal (ULN), SGOT and SGPT \</= 3 x ULN, except \</= 5 x ULN in leukemic involvement of the liver, serum creatinine \</= 2 x ULN
* WHO performance status 0-3
* A negative serum hCG pregnancy test in patients of childbearing potential
* Able to give signed informed consent directly or through a parent or guardian for minors

Exclusion:

* Leukemic involvement of the central nervous system
* Active malignancy other than CML or non-melanoma cancer of the skin
* Previous treatment for CML with another investigational agent within 28 days of study entry
* At study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
* Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
* Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
* Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
* Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
* Patients with systemic, uncontrolled infections
Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).

The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.

we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
3. Not amenable to pulmonary endarterectomy
4. Willing to provide informed consent

Exclusion Criteria:

1. Patients unwilling or unable to provide written consent for participation in the study.
2. Impossible to follow up.
Population-based Study in Screening for Liver Fibrosis

Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

This is a population-based study. Subjects will attend a primary care center where a physical examination, general blood test and transient elastography will be carried out. Only the group of patients with high-risk for liver fibrosis will be evaluated in a second visit at the University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* Able to give informed consent

Exclusion Criteria:

* Previously known chronic liver disease (including cholestasis). Patients with already known liver steatosis but no diagnosis of liver fibrosis or cirrhosis can be included
* Subjects with mental incapacity, language barrier, insufficient social support or any other reason considered by the investigator precluding adequate understanding or cooperation in the study
* Subjects with a history of current malignancy including solid tumors and hematologic disorders
* Subjects with significant extrahepatic disease that may impair short-term prognosis (including congestive heart failure New York Heart Association Grade IV, COPD GOLD \>3)
* Subjects with kidney disease (serum creatinine \>3mg/dL or under renal replacement therapy)
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus

This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.


Eligibility Criteria:
Inclusion Criteria:

* SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4
* Active arthritis in \>=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score \>=6.
* Anti-dsDNA antibodies \>15 IU/mL.
* Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:

  * Corticosteroids \<=20 mg/day (prednisone or equivalent) for at least 2 weeks prior to first IP dosing; AND/OR
  * Non-steroidal anti-inflammatory drug (NSAIDs); AND/OR
  * One single antimalarial at a stable dose (hydroxychloroquine \<=5 mg/ kg/day, quinacrine 100 mg/day, or chloroquine 2.3 mg/kg/day) for at least 8 weeks prior to first IP dosing; AND/OR
  * One single immunosuppressant at a stable dose (azathioprine (AZA) \<=2 mg/kg/day, methotrexate (MTX) \<=20 mg/week, or mycophenolate mofetil (MMF) \<=2 g/day) for at least 8 weeks prior to first IP dosing.
* estimated glomerular filtration rate (eGFR) \>=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Lupus nephritis \>= Class III
* Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).
* Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection \>0
* Unstable condition not related to SLE
* Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis
* Sjögren's syndrome and/or antiphospholipid antibody syndrome who do not require treatment with any prohibited medication are NOT excluded.
* Active systemic infection
* Poorly controlled chronic cardiac, pulmonary, or renal disease.
* Known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections
* Treatment with disallowed therapies

This list only contains the key exclusion criteria.
Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects

The purpose of this 2-stage intervention study is to investigate the effect of a novel nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and weight loss maintenance in obese participants.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 and ≤ 47

Exclusion Criteria:

* Prohibited medications, supplements or herbal products

  1. Use of narcotics, oral or injectable corticosteroids, multivitamin/multimineral supplements, antioxidant supplements, vitamin D supplements, probiotics and omega-3 fatty acid supplements 30 days prior to screening and for the duration of the study.
  2. Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
  3. Change in prescription, OTC, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
* Medical history and concurrent diseases

  1. Known allergy or hypersensitivity to study product or placebo.
  2. Clinically significant abnormalities in medical history of physical examination.
  3. Clinically relevant conditions expected to preclude achievement of exercise recommendation.
  4. Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
  5. Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, TB ,hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness.
  6. Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
  7. Use of drugs of abuse (e.g. marijuana, cocaine, PCP, and methamphetamine) within 30 days prior to screening and for the duration of the study.
* Other criteria

  1. Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
  2. Initiation of a new or change of an existing food plan within 30 days prior to screening.
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication

To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.

The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form.

Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience.

Follow-up: Includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~75,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
3. Patients are willing to receive eradication treatment.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Contraindications to study drugs.
2. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
3. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
4. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
5. Pregnant or lactating women.
6. Underwent upper gastrointestinal Surgery.
7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
8. Evidence of bleeding or iron efficiency anemia.
9. A history of malignancy.
10. Drug or alcohol abuse history in the past 1 year.
11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
12. Patients who has psychological problem or poor compliance.
13. Enrolled in other clinical trials in the past 3 months.
14. Refuse to sign informed consent.
Art Therapy Program in the Chronic Phase of Stroke

INTRODUCTION: After stroke, perceptual impairments, such as negative body perception, contribute to social isolation and depression. In the subacute poststroke phase, art therapy is effective in improving depression, self-esteem, and community integration. Yet, no study has explored the effectiveness of art therapy at the chronic stage of a stroke; where motor recovery is slowed, and body image and self-esteem are deeply challenged.

OBJECTIVES: Primary; to assess the feasibility of an art therapy program (ATP) in the chronic phase of stroke. Secondary; to explore the effects of ATP on perceptual impairment (body image/self-esteem), mood and community integration.

METHOD: Nine adults (stroke ≥6 months) will participate in the ATP consisting of a thematic group visit to the Montreal Museum of Fine Arts followed by an art workshop, supervised by an art therapist (7 visits over 4 months). Feasibility will be evaluated by triangulating data from interviews and subject assessment questionnaires and by assessing retention and attendance. The effects of the ATP will be assessed by changes in perceptual and mood impairment questionnaires (Body Image States, Self-Esteem scales, Beck Depression Inventory-Short-Form) and community integration questionnaire (The Community Integration Questionnaire).

EXPECTED RESULTS AND OUTCOMES: The project will confirm the feasibility of ATP to improve perceptual impairment and community integration post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* be in the chronic stroke phase (≥ 6 months since diagnosis)
* present a low score on the self-esteem scale (score \< 32/40 on the French-Canadian Self Esteem Scale)
* present mild to moderate degree of depression (score 4 to 15 in the Beck Depression Abbreviated Inventory)

Exclusion Criteria:

* unable to move autonomously and safely on their own
* present aphasia (score \< 28/35 in the communication section of the Stroke Impact Scale)
* present severe hemineglect (score \> 70% in the Line Cancelation Test)
* present severe spasticity of the hemi-body (score ≥ 3 on the modified Ashworth scale)
* present cognitive impairment (score ≤ 2/5 in the Mini-Cog)