cyrilzakka/clinical-trials huggingface dataset:
Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).

210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.

Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.

Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
* Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed.
* Patients must have measurable disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months.
* Adequate bone marrow, liver and renal function
* Left ventricular ejection fraction (LVEF) ≥ 50% or the lower limit of normal (LLN) according to local institution ranges of normality.

Exclusion Criteria:

* More than 1 previous systemic anti-cancer therapy line
* Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the investigator in consultation with the ophthalmologist.
* Brain metastases, meningeal tumours or other metastases in the central nervous system
* Evidence of history of bleeding diathesis.
* Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade \> 2.
* Pre-existing cardiac conditions
Alcohol and Cigarette Craving During Oxytocin Treatment

This proposed research seeks to examine the behavioral and neural substrates of intranasal oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.


Eligibility Criteria:
Inclusion Criteria:

1. male or female
2. 18 to 55 years of age
3. meet criteria for Alcohol Use Disorder DSM-5 diagnosis
4. meet the National Institute on Alcohol Abuse and Alcoholism criteria for heavy-drinking
5. smoke at least ≥5 cigarettes/day for at least a year, verified with breath carbon monoxide level \> 5 ppm
6. in good health as confirmed by medical history, physical examination and lab tests
7. willing to take the medication and adhere to the study procedures
8. breath alcohol concentration (BrAC) = 0.00 at each visit
9. understand informed consent and questionnaires written in English at an 8th grade level
10. right-handedness
11. normal to normal-corrected vision

Exclusion Criteria:

1. positive urine test for pregnancy
2. women who are breast-feeding
3. body mass index \> 40
4. current or prior history of any clinically significant disease, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, positive hepatitis or HIV test that could affect study participation, as determined by the study physician
5. history of suicide attempts
6. current diagnosis of substance dependence other than alcohol, nicotine or cannabis as assessed by self-report and urine toxicology screen at baseline
7. current use of psychoactive medications or any medication that may interact with oxytocin
8. history of hypersensitivity to oxytocin
9. chronic rhinitis or sinusitis
10. clinically significant electrolyte abnormalities
11. vasoconstricting medications or prostaglandins
12. clinically significant medical abnormalities: unstable hypertension, bilirubin \>150% of the upper normal limit (UNL), ALT/AST \>500% the UNL, creatinine clearance ≤60 dl/min)
13. significant alcohol withdrawal symptoms, defined as a CIWA-Ar \> 8
14. positive urine drug screen at baseline for any excluded substances
15. individuals seeking treatment
16. meets DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
17. claustrophobia
18. any contraindications with the MRI machine
The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer. Diagnosis of Pancreatic Cancer

Previous research has shown that microRNAs in the blood can serve as biomarkers for early pancreatic cancer, with potential applications including detection, differential diagnosis, and prognosis prediction of pancreatic cancer. The current primary method for detecting microRNAs is RT-qPCR, but this process requires repeated temperature cycling, which demands high precision from the equipment. As an alternative, isothermal nucleic acid amplification technology does not require expensive temperature control instruments. Our research team has developed various isothermal nucleic acid amplification strategies for microRNA sensing platforms, applied to biological sample detection. This study combines the circular strand displacement amplification strategy with DNA nanomachines to develop a fluorescence sensing platform that performs dual signal amplification at a constant temperature. It is designed to detect pancreatic cancer-related microRNAs, exploring its role and potential applications in the diagnosis of pancreatic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic ductal adenocarcinoma
* Proven by pathology
* Patients who have not received anti-cancer therapies

Exclusion Criteria:

* Less than 20 years old
* Unable to provide inform and consent
* Patients who have active malignancy other than pancreatic adenocarcinoma
* Patients who have had pancreatic cancer whose anti-cancer therapies are completed or undergoing
* Life expectancy less than 3 months
Impact of Adding a Limitation Section in Abstract of Systematic Review

Objective: The investigators aim to evaluate the impact of a adding a " limitations " section in systematic review's abstract on result's interpretation by readers Design: randomized controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of clinical trials published between 2010 and 2012 and referenced in Medline.

Intervention: The investigators will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta- analysis. The investigators selected abstracts of meta-analysis from a sample.

Selected abstract will be standardised and the treatment's name hidden. Two groups of abstract will be presented as follow: 1) abstract without " limitations " section 2) abstract with " limitations " section. The " limitations " section will be written by authors and will briefly describe the risk of bias of included studies.

Selected participant are invited by e-mail to answer the survey. After reading one abstract from his/her group of randomisation they are invited to answer 5 questions about their interpretation of the results.


Eligibility Criteria:
Inclusion Criteria:

* corresponding authors of clinical trail indexed in pubmed with email address available
Jackson Heart Study Women's Hypertension Study

High blood pressure is a powerful risk factor for heart disease. Black women are more likely to have high blood pressure than white women or Hispanic women. Even when they are aware they have high blood pressure, many people struggle to keep their blood pressure controlled. Research shows a connection between life stress and high blood pressure and heart disease outcomes. Mindfulness training programs can help people regulate their emotions and cope with stress. Research shows that mindfulness programs can also lower blood pressure. This study will compare two programs: MIND-BP, a Zoom-based mindfulness training group; and BOOST, a Zoom-based support group. The aims of the study are to test if the MIND-BP program leads to greater reductions in blood pressure, stress and depressive symptoms than the BOOST program in Black women with high blood pressure who are participating in the Jackson Heart Study. The primary outcome measure is 6-month change in systolic blood pressure. The secondary outcome measures are 6-month changes in perceived stress and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Female participant in Jackson Heart Study
* Willing to be randomized and comply with all aspects of protocol
* Willing to be audio-recorded during group sessions.

Exclusion Criteria:

* Positive cognitive screen (MMSE \<19)
* Severe depressive symptoms (CES-D ≥16)
* Pregnant or planning to become pregnant in the next 6 months
* Current participation in another trial
* Arm circumference \>45 cm and \<22 cm
Rajaie Cardiomyopathy and Myocarditis Registry

The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry


Eligibility Criteria:
Inclusion Criteria:

1. age greater than one year
2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria
3. able to give informed consent or in the case of child consent from a parent

Exclusion Criteria:

Patients who have not consent to participate in the study.
Parents' Occupation After Diabetes Onset

A cross-sectional multicenter study using a questionnaire assessing occupational and financial situation before and after the onset of type 1 diabetes was distributed to all families with a child diagnosed with type 1 diabetes before the age of 14 years in nine German pediatric diabetes centers.

This cross-sectional multicenter study was conducted between January and June 2018 during a three months period per center. The selected nine pediatric diabetes centers covered all regions of Germany. The study participants were mothers, fathers, or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age. During a regularly scheduled medical visit, in Germany usually 4 per year, families were informed about the study procedure, its aims and anonymous data collection and analyses. The answered questionnaires were either collected in a closed box in each diabetes center or could be sent anonymously via a prepaid envelope to the study administration center.

Eligibility Criteria:
Inclusion Criteria:

* mothers, fathers or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age
* child's diabetes duration at least 12 months
* child's age under 19 years

Exclusion Criteria:

* caregivers unability to understand German language sufficiently
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract.
* Subjects must have clear intraocular media other than cataract.
* Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with diagnosis of degenerative visual disorder.
* Subjects who have any inflammation or edema (swelling) of the cornea.
* Subjects with immunodeficiency disorders.
* Subjects who have had previous intraocular surgery in the study eye.
* Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer

This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.

This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent/assent for the trial.
* Life expectancy ≥12 weeks.
* Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
* Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
* Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
* Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
* Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
* Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Exclusion Criteria:

* Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
* Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
* Allergic to study therapy.
* Has a known additional malignancy that has had progression or has required active treatment in the last five years.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
* Has had an allogeneic tissue/solid organ transplant.
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma

Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50
* No systemic therapy
* All Co-morbids

Exclusion Criteria:

* Pregnancy
* Age \>50
* Taking oral treatment for melasma
Validation of the Telematic Version of the Fugl-Meyer Scale

Stroke is one of the most prevalent pathologies worldwide and its consequences require long-term treatment. The current situation caused by the Sars-cov-2 virus has collapsed health systems and has delayed these patient's treatment. The proposed alternative is telerehabilitation: a treatment system that has already proved its effectiveness. However, the difficulty to assess the stroke patient's functional status is the great problem. For this reason, a Fugl Meyer Assessment Scale adaptation, one of the most widely used (in research and in clinic), is proposed to be carried out remotely. The objective of our study is to validate this scale in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Being older than 18-years-old
* Diagnosis of stroke

Exclusion Criteria:

* Another neurological or orthopedic problem different than stroke that will affect functionality and balance
An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options

The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.

This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) in patients with a primary diagnosis of idiopathic gastroparesis (a disorder of unknown cause in which the stomach empties its contents very slowly into the small intestine for digestion. Symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. Patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. Study drug will be taken approximately 15 minutes before each meal, and, with a beverage, before going to bed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with nondiabetic idiopathic gastroparesis and having symptoms for at least 12 weeks in the preceeding 12 months
* Experienced inadequate response, or intolerance to therapy to date
* Have exacerbation of gastroparesis symptoms requiring medical attention
* Demonstrate delayed gastric emptying as assessed by a \[1-13C\]-Sodium Acetate Breath Test within 14 days before randomization

Exclusion Criteria:

* Received prior treatment with cisapride
* Have a gycosylated hemoglobin (HbA1c) \>7% and bloodglucose of 126 mg/dL (7.0 mmol/L) or greater at screening, as determined by clinical laboratory testing
* Have any upper gastrointestinal (GI) pathology other than idiopathic gastroparesis that would require therapy other than that provided in this trial
* Have any organic/neurological disease that is suspected to be causing gastroparesis
* Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
* Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
* Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.

Exclusion Criteria:

* Female patients who are either pregnant or nursing.
* Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
* Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
* Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
* Patients who have been judged clinically to be serious suicidal risks.