cyrilzakka/clinical-trials huggingface dataset:
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters

Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality. Effective screening tools are needed to identify women at risk, enabling timely preventive and therapeutic interventions.

Current screening methods primarily target placental biomarkers like sFLT1 and PlGF, which are limited to short-term predictions near symptom onset. Existing first-trimester assessments that incorporate maternal factors and Doppler metrics remain constrained by low sensitivity (\<41%) in compliance with NICE and ACOG guidelines.

Recent advancements in cell free RNA (cf-RNA) analysis have revealed potential in first-trimester PE prediction. Findings from the PREMOM study (NCT04990141) established a molecular profile for early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) through cfRNA analysis, culminating in the development of the MaiRa Preeclampsia Test (Maternal Advanced and Innovative Preeclampsia Risk Assessment), which demonstrated high predictive performance for first- and second-trimester screening.

The current study hypothesizes that the MaiRa Preeclampsia Test is generalizable, maintaining its predictive accuracy in an independent cohort.

This multicentre, prospective observational study aims to validate the MaiRa Preeclampsia Test, a molecular screening tool for predicting early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) in the first and second trimesters of pregnancy. The study will evaluate its diagnostic accuracy, including sensitivity, specificity, predictive values, and area under the curve (AUC).

Study Design:

Duration: 30 months

* Recruitment and Sample Collection: 18 months
* Sample Analysis: 12 months
* Follow-Up: 8 months
* Statistical Analysis and Publication: 6 months Participants: 7,473 pregnant women from 12 tertiary hospitals in Spain.

Visits:

* Visit 1 (T1): 9-14 weeks' gestation (first blood sample)
* Visit 2 (T2): 15-26 weeks' gestation (second blood sample)
* Visit 3 (T3): ≥27 weeks' gestation (third blood sample)

Blood samples will be analyzed using the MaiRa Preeclampsia Test, with results correlated against obstetric outcomes as the gold standard. Data will be documented in an electronic Case Report Form (eCRF). Quality assurance will be maintained via continuous data monitoring and verification.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent approved by the Ethics Committee.
* Women ≥18 years of age at consent.
* Single gestation pregnancies with first sample collection (T1) possible between 9 and 14 weeks' gestation.

Exclusion Criteria:

* Active neoplasm.
* History of organ or bone marrow transplantation.
* Maternal transfusion within 8 weeks before sample collection.
* Evidence of early pregnancy loss at consent.
* Severe, uncontrolled infections.
* Other investigator-assessed risks that could compromise participation or data quality.
Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function

Chinese version of the cognitive function test of schizophrenia (MCCB) . To explore a predictive model for long-term medication use in patients based on cognitive function


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years _Meet the diagnostic criteria for schizophrenia in ICD-10

Exclusion Criteria:

* Other people with mental illness
MEMO-Medical Marijuana and Opioids Study

The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events.

The overarching goal of the study is to understand how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis. Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week time period (unit of analysis), the primary exposure measure will be number of days of medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative findings will help understand the reasons underlying the findings of the cohort study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* English or Spanish fluency
* New certification for medical cannabis within 90 days
* No medical cannabis use in the 6 months prior to certification
* Medical cannabis qualifying complication of "chronic or severe pain"
* Use of prescribed or illicit opioid analgesics within 30 days

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete study visits over 18 months
* Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's disease)
* Terminal illness
* Current or prior psychotic disorder
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

The primary objective is:

* To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy

The secondary objectives are:

* To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy
* To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy
* To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy.
* To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy


Eligibility Criteria:
Inclusion criteria:

* Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2
* Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy
* Fatigue \> or = to 4 on the MD Anderson Symptom Inventory fatigue assessment scale during the previous docetaxel chemotherapy cycle
* SPHERE somatic (SOMA) subscale score \> or = to 3
* Worsening of fatigue after commencement of docetaxel chemotherapy
* Haemoglobin (Hb)\> or = to 10 g/dL within two weeks before randomisation

Exclusion criteria:

* Unable to complete the MD Anderson Symptom Inventory fatigue assessment scale or Functional Assessment of Chronic Illness Therapy-Fatigue Quality of Life survey
* Require docetaxel chemotherapy dose reduction to less than 50 mg/m2
* History of chronic fatigue condition
* Uncontrolled hypertension (blood pressure \> or = to 150/90 mm Hg
* Known hypersensitivity / intolerance to modafinil or any of the excipients
* Pregnant women
* Psychological, familial, sociological, or geographical conditions that do not permit treatment or medical follow-up and / or prohibit compliance with the study protocol
* Any serious concomitant illness that, in the opinion of the Investigator, would preclude a patient from participating in the study
* Non-English speaking

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of a Personalized Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults

The proposed study has two primary objectives i.e. to examine how improvements in diet quality via a personalized dietary intervention 1) benefit cardiometabolic outcomes in young Black adults differentially compared to non-Hispanic White adults, and 2) improve carbohydrate and lipid metabolism in relation to the gut microbiome.

The study is an 8-wk randomized, controlled, parallel arm clinical trial in which participants (age: 18-35 years, BMI: 25-45 kg/m2, race/ethnicity: Black or White) will be block randomized to a personalized dietary intervention or to receive conventional dietary advice. Outcomes assessed will include metabolites involved in carbohydrate and lipid regulation, gut microbiome composition, and cardiometabolic biomarkers.

Eligibility Criteria:
Inclusion criteria:

* Age: 18-35 years of age
* BMI: 25-45 kg/m2
* Black including those of Hispanic ethnicity, and Non-Hispanic White individuals
* Willingness to consume nuts, fruits and vegetables
* Willing to comply with study protocol
* Consistent diet and activity patterns for 4 weeks
* Weight stable (≤5 kg change over the last 3 months) (Self-reported)
* Non-smoker \>1 year or more

Exclusion Criteria:

* Allergies to fruits, vegetables, and nuts provided in the study
* Illicit drug use
* Recent start of medications that affect metabolism or appetite
* Antibiotics
* Coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia requiring drug therapy
* Uncontrolled hypertension and blood pressure ≥ 180/110 Diabetes
* Gastrointestinal disease and/or bariatric surgery
* HIV positivity
* Pregnant or lactating individuals
Group Empowerment of Battered Women as a Tool for Violence Prevention

Intimate partner violence against women is a significant global health problem. This study was designed to test the hypothesis that a group intervention based on empowerment theory of Paolo Freire would be effective as a means to reduce the extent and prevent violence among women whose partners were violent toward them.

A randomized controlled trial (N=141) with two control groups (one individual psychotherapeutic treatment and the other a usual care group treatment) was conducted in a violence treatment center in the South of Israel The treatment protocol designed to empower battered women (EBW) was conducted with 12 groups over a period of two years. Assessments were made before, immediately following and at an 8 month follow up following the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women living in the south, who had approached the center for help as battered women
* Could fill out forms in Hebrew
* Aged 20 and above

Exclusion Criteria:

* Age younger than 20
* Not able to fill out forms in Hebrew
* Not living in the southern district of Israel
Zirconia Based Fixed Dental Prostheses

The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Missing of at least two adjacent teeth in the maxilla or mandibular
* Sufficient oral hygiene

Exclusion Criteria:

* Addiction to alcohol or drugs
* Severe craniomandibular disorders
* Severe systematic diseases
* Patients unable or unwilling to sign the informed consent form
* Untreated periodontitis
Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer

Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).

* A first blood sample will be taken during the week before the operation. A second blood sample will be taken 4 to 8 weeks after the operation. And in case of relapse, a third sample will be taken. These samples are going to be stored in the collection of biological resources of Angers.
* Concerning the biopsy of the resected NSLCL, it will be sent to the collection of biological resources of Angers for conservation directly next to the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Major subject
* Subject who received resection with primary non-small cell lung cancer at the University Hospital of Angers and whose tumor samples will be stored in collection of biological resources of University Hospital of Angers
* A written inform consent.

Exclusion Criteria:

* Under 18 year old;
* Pregnant or nursing women;
* Deprived of liberty;
* Age under curatorship or guardianship;
* Unable to consent person;
* About not carrying a non-small cell lung cancer.
Conservative Treatment in Lateral Epicondylitis

Conservative treatments follow the vast majority of treatments in lateral epicondylitis. In this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were ≥18 years of age, and had no history of elbow surgery.
* Participants should have pain and sensitivity, with symptom duration less than 12 weeks.
* Patients with a positive result in one of the provocation tests (Maudsley's Test-resisted middle finger extension extensor carpi radialis test), resisted wrist extension, or passive stretching of the wrist extensors (Mill's Test) were included.

Exclusion Criteria:

* Patients under 18 years of age,
* patients who did not consent to participate in the study,
* those who had previous surgery on the elbow,
* presence of cervical spondylosis and radiculopathy,
* presence of endocrine disease,
* presence of autoimmune disease,
* presence of concomitant entrapment neuropathy or polyneuropathy,
* pregnancy,
* presence of systemic inflammatory disease,
* presence of acute trauma,
* presence of deformity in the upper extremity,
* presence of metabolic disease,
* presence of elbow arthritis,
* presence of allergy to kinesio tape and orthoses,
* having received treatment for lateral epicondylitis in the past (exercise, injection, NSAIDs).
Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic

The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.

To achieve these goals, the investigators will pursue the following Specific Aims:

Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.

Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.

Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.

Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be patients of the DOC.
* BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).

Exclusion Criteria:

* Mental illness that would cause disruptions to group meetings
* Cognitive impairment that would preclude participants from understanding the program
* Type 2 diabetics on insulin or sulfonylureas without provider approval
* untreated hyper- or hypothyroidism
* current cancer diagnosis
* history of cancer (other than skin cancer)
* gastrointestinal disorders affecting food intake
* use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
* women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
* weight loss of \> 5% in past 6 months
* major psychiatric disorder
* current moderate to severe symptoms of depression
* eating disorders
* current alcohol or substance abuse.
Ability to Cope With Type 1 Diabetes

The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility.

In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be type 1 diabetic
* English/spanish speaking
* The legal guardian must be present.

Exclusion Criteria:

* Non-cognitive or mentally ill
* Under the age of 8.0 years
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
* Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
* HbA1c of ≥6.5% and ≤10.5% at screening

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
* Past or current history of severe diabetic complications
* Patients requiring insulin therapy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);
* The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;
* Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).

Exclusion Criteria:

* History of severe scoliosis, vertebroplasty, or internal spinal fixation;
* Presence of spinal infection and malignant neoplastic disease;
* Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).
Prevention of Thromboembolic Events in Total Knee Replacement Patients

The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
* Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
* Body weight between 50 kg and 130 kg inclusive.
* Normal aPTT, PT, INR at screening

Exclusion Criteria:

History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).

Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR \< 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C \>10%); Liver dysfunction (ALT/AST \>3 xULN or TBL \>2 x ULN); BMI ≥ 40 kg/m2