cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors

Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.

This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent document.
* Age 18 and older.
* Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis).
* Progressive disease after multiple-lines treatment.
* Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
* Able to remain motionless for up to 30-60 minutes per scan.

Exclusion Criteria:

* Serum creatinine level \>150 μmol/L.
* Hemoglobin level \<8.0 g/dL; white-cell count \< 2.0×109/L; platelet count \< 50×109/L; total bilirubin level \>3 times the upper limit of the normal range and serum albumin level \<2.0 g/dL.
* Participants with Class 3 or 4 NYHA Congestive Heart Failure.
* Participants with severe allergy, or hypersensitivity to radiographic contrast material.
* Participants with claustrophobia.
* Pregnant or lactating women.
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females, defined as one from the next :

  1. Natural menopause ≥1 year,
  2. Surgical ovariectomy,
  3. Chemotherapy-induced amenorrhoea ≥ 2 years.
* Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
* Patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.
* Patients whose tumour was estrogen receptor positive (ER+).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients for whom Aromasin® treatment is contraindicated (see SmPC).
* Metastatic breast cancer or a contra lateral tumour.
* Other concomitant adjuvant endocrine therapy.
* Other concomitant antineoplastic treatment.
* Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Disulfiram in Treating Patients With Glioblastoma Multiforme After Radiation Therapy With Temozolomide

This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed GBM (WHO grade IV).
* At least 18 years of age.
* ECOG performance status of at least 2.
* Has received or is in the process of completing a course of definitive radiotherapy of at least 45 Gy with concurrent temozolomide (patient may be registered before completing radiotherapy as long as it is anticipated that s/he will complete at least 45 Gy).
* Eligible for and planning to receive maintenance temozolomide after completion of definitive radiotherapy plus temozolomide.
* Willing to remain abstinent from consuming alcohol while on disulfiram.
* Meets the following laboratory criteria:

  * Absolute neutrophil count ≥ 1,500/mcL
  * Platelets ≥ 100,000/mcL
  * Hemoglobin \> 9.0 g/dL (transfusion and/or ESA allowed)
  * Total bilirubin ≤ 2x institutional upper limit of normal (ULN)
  * AST and ALT \< 3 x ULN
  * Calculated creatinine clearance must be \> 60 mL/min (by Cockcroft-Gault)
* Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to take oral medication.
* Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).

Exclusion Criteria:

* Receipt of any other investigational agents within 14 days prior to study enrollment.
* Enrolled on another clinical trial testing a novel therapy or drug.
* History of allergic reaction to disulfiram.
* Treatment with clinically significant cytochromes P450 enzyme inducers, such as phenytoin, phenobarbital, chlordiazepoxide, diazepam, isoniazid, metronidazole, warfarin, amitriptyline within 14 days prior to the first dose of disulfiram. Of note, lorazepam and oxazepam are not affected by the P450 system and are not contraindicated with disulfiram.
* Active or severe hepatic, cardiovascular, or cerebrovascular disease, including myocardial infarction within 6 months prior to enrollment, have New York Heart Association (NYHA) Class III or IV heart failure (Appendix B), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* History of idiopathic seizure disorder, psychosis or schizophrenia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of initiation of treatment.
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay

This exploratory study used a pre-post test design. The supervised rehabilitation program was performed three times a week for 8 weeks (two sessions at a rehabilitation gym and one pool session). Outcome measures included Ottawa sitting scale, 30-Second Chair Stand test, Berg Balance Scale, 10-Meter Walk Test, 6-minute Walk Test, modified Activities-specific Balance Confidence Scale and SARA scale. 10 participants will complete the training program. They will be evaluated at baseline, at week 4 (miway) and after the program.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent

Exclusion Criteria:

* Having other medical diagnosis causing physical limitations
Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients

Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New ("de novo") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation

No apply

Eligibility Criteria:
Inclusion Criteria:

* Patient with "de novo" heart Failure and LVEF \<= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent.

Exclusion Criteria:

* Contraindications for BB.
* Living in a nursing home.
* Life expectancy \< 6 months.
* Unable to self-care or mental disease without caregiver.
* Unable to weight
* Without phone
* Unable to go to clinic visit.
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

MTD - maximum tolerated dose

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
* Subjects who have overall good overall general condition.
* Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15.
* Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
* Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits

Exclusion Criteria:

* Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
* Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
* Subjects with symptomatic uncontrolled brain metastases.
* Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
* Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.
Examining Effects of Holistic School Enrichment Programs

The investigators propose to evaluate the efficacy of a Mindful Movement Intervention (MMI) within the Baltimore City Public School (BCPS) system. The goal is to help at-risk youth improve skills important to attentional, behavioral, motor, and emotional control through engagement of mindful movement practices.

To assess the feasibility and efficacy of the program, standardized assessments will be conducted at three time points: the beginning of the school year at the start of the intervention (early September), at the mid-year point (late January), and prior to the end of the school year (early June). During these assessments, participants will be pulled out of their academic classes for brief sessions (1 hour) in which they will complete assessments of attentional, behavioral, motor, and emotional control. At these assessment points, parents and teachers will complete rating forms about the children including assessments of emotional, behavioral, and attention regulation.

Research participants will have the option to reinforce mindful movement practices using a family-based curriculum, participating in peer mentorship, and supporting the development of community educational materials.


Eligibility Criteria:
Inclusion Criteria:

1. Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days.
2. Students with a diagnosis of depression, anxiety, autism, oppositional defiant disorder, and post traumatic stress disorder can be included in the research study
3. Students taking stimulant medications and all other psychoactive medications can be included in the research study.
4. Students in general education classrooms with supports, aides, and/or pull-outs

Exclusion Criteria:

1. Diagnosis of...

   * intellectual disability
   * a neurological disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)
   * conduct disorder or a recorded history of symptoms consistent with conduct disorder
   * a documented hearing impairment ≥ 25 dB loss in either ear
   * significant learning difficulties that require a special education plan.
2. Students in foster care
3. Students who are or may be pregnant
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators

Each subject enrolled in the study will be requested to complete an intake questionnaire including diabetes quality of life questions. The subject will use Dario Blood glucose monitoring system and will be contacted by a Certified Diabetes Educator (CDE) two to three times a month as well as have a direct communication using other communication channels such as mail, chat and text messaging (SMS) for lifestyle and diabetes management coaching for a total duration of three months. In the end of study, the subject will complete a diabetes quality of life questionnaire and have a blood test to evaluate its clinical parameters.

This study is designed to assess the effect of digital self-monitoring platform used with the remote support of a Health coach on clinical outcomes and Diabetes quality of life.

Study design will be an open-label randomized trial of adults with Type 2. Patients are recruited through the Diabetes and Endocrinology Consultants center setting. Upon randomization to the intervention group, study participants will receive three months diabetes health coaching comprising of:

1. Two scheduled phone sessions with a Diabetes health coach a month;
2. Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails
3. Diabetes education, behavior modification, goal setting and reinforcement. The Dario App will record participant's glucose measurements and additional information captured by the patient such as medication intake, food and physical activity results.

The coach will get access to the patients' App captured information and will intervene ad necessary in the context of the clinical information.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, a subject must meet all the following criteria:

1. Adults 35 years of age or older
2. Diagnosed type 2 Diabetes
3. HbA1C test taken less than 2 months ago and is equal to or above 8.5%
4. Able to read, write and understand English
5. Have supported smartphone (see appendix C for the full smartphone list) with internet package for their service provider
6. The subject is able and agrees to sign the informed consent form

Exclusion Criteria:

1. Adults with impaired cognition
2. Cohabiting with a participant in the study
3. Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels
4. Subject is critically ill
5. Subject has an impairment that prevents him/her from following the study procedures
6. Subject is not using medication that may interfere with the blood glucose measurement
7. HCT level which are outside Dario BGMS declared range (20%-60%)
Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study participation. In addition to these procedures, the study team will collect the mother's medical and obstetrical histories. Should irregular heart rhythms be detected at home, the mother will contact the investigator to be evaluated. After the baby is delivered, the study team will collect information about the baby's birth and heart rhythm evaluation (electrocardiogram).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with positive SSA or SSA and SSB antibodies
* Gestational age (GA) between 16 and 19 weeks
* No signs of antibody-mediated fetal cardiac disease on pre-enrollment echo

Exclusion Criteria:

* Subjects who are more than 19 weeks gestation
* Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included
Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis

Epoetin alfa is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with chronic kidney disease, information on its effectiveness and long-term safety for treatment of anemia associated with rheumatoid arthritis is limited. This 35-week safety study is an extension of a 20-week, prospective, randomized, double-blind, placebo-controlled, multi-center study that investigates effectiveness of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis. The study hypothesis is that there will be no long-term safety concerns of epoetin alfa administered once every two weeks in rheumatoid arthritis patients with anemia of chronic disease. Patients will receive epoetin alfa injections (40,000 units) under their skin once every 2 weeks for up to 31 weeks. Doses may be adjusted depending on the patients' hemoglobin level up to the maximum of 60,000 units once every 2 weeks or 40,000 units once weekly.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have signed an informed consent
* Women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test at Week 1 of the study
* Women must not be breast feeding during this study period
* Patients must have completed the double-blind (DB) study (PR03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dL at Week 20 of the DB study

Exclusion Criteria:

* Uncontrolled hypertension
* Elective surgery, including joint replacement, anticipated to require transfusion during the extension study period
* Thromboembolic event during the double-blind study including acute myocardial infarction, Cerebrovascular accident and/or transient ischemic attack
* Deep vein thrombosis and/or pulmonary embolism
* Uncontrolled psychiatric disease or other co-morbid disease that have developed or worsened since enrollment to the double-blind study
* Planning to be enrolled in any other clinical trial during the course of this study
Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

This registration enrolled patients with acute ischemic stroke within 72 hours after stroke ictus. Patients was identified as first-ever stroke based on past medical histrory. Admission CT was conducted to exclude hemorrhagic stroke, but not those bleeding transformation after ischemia injury. Baseline characteristics, including demographics, vascular risk factors, lab tests and neuroimagings were collected. Patients were followed up for cognitive assessments.

This is a perspective stroke registry cohort study. Stroke patients were included if ：(1) acute first-ever ischemic stroke and admitted within 72 hours after onset; (2) clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ; (3) presented with mild stroke severity ( admission NIHSS score ≤5); (4) age between 40 and 80 years.

Clinical data including demographic characteristics, risk factors, and baseline NIHSS score were assessed and collected using a standardized table by experienced neurologists. Lab tests were performed with fasting venous blood samples within 18 hours of admission.

Patients were followed up for 6 months. The cognitive functions were assessed using the Chinese version of Montreal Cognitive Assessment (MoCA).

Contributing factors to post-stroke cognitive impariment (PSCI) were determined by comparing clinical data between PSCI and non-PSCI groups. All potential confounders were introduced into the multivariate regression models.

Eligibility Criteria:
Inclusion Criteria:

1. acute first-ever ischemic stroke and admitted within 72 hours after onset;
2. clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ;
3. presented with mild stroke severity ( admission NIHSS score ≤5);
4. age between 40 and 80 years.

Exclusion Criteria:

1. Patients with index cognitive impairment or under current anti-dementia or psychiatric medication;
2. patients with large infarcts (≥1/3 middle cerebral artery territory);
3. patients with severe language or physical disability that impede neuropsychological testing;
4. patients with recurrent transient ischemic attack (TIA)/stroke during follow-up;
5. coexisting serious conditions known to impair cognitive function