cyrilzakka/clinical-trials huggingface dataset:
Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients treated at Texas Oncology, the designated research organization and a community oncology practice. The first date of a new diagnosis of advanced BC (de novo or progressed to advanced BC) defined the study index date. To allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was required.


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the following criteria were eligible for abstraction:
* Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020
* Evaluated for a PIK3CA mutation and identified PIK3CA gene status
* No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
* At least 18 years of age at the time of first diagnosis of BC
* Patients may be alive or deceased at the time of abstraction
* Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:

  * SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)
  * BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib (BKM120)
  * SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)

Exclusion Criteria:

None
Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.

The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic membranous nephropathy
* Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g
* Voluntarily participated in the study and signed an informed consent

Exclusion Criteria:

* Combined life-threatening complications such as serious infection
* Abnormal glucose metabolism
* Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc
* Pregnancy or breast-feeding women
* Undergoing other clinical trials
Mobile Health Intervention to Improve Exercise in Pediatric PH

Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents between ages 13-19 years.
* Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
* WHO functional class I-III
* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
* Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.

Exclusion Criteria:

* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
* Pregnancy
* Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
* Functional class IV heart failure
* Requirement of \> 2 diuretic adjustment in the prior three months.
* Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
* Involved in any other investigational intervention.
Magnesium Sulphate in Perinatal Asphyxia

Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.

Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.

Eligibility Criteria:
Inclusion Criteria:

* Babies eligible for the study were:

  1. Term or post term
  2. Less than 6 hours of age and had
  3. severe perinatal asphyxia as manifested by any three of the following criteria.

     * History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid)
     * Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery
     * A 5-minute Apgar score of \< 6
     * Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy

Exclusion Criteria:

* Patients with severe IUGR
* Any condition unrelated to asphyxia
* Maternal prenatal magnesium administration
* Metabolic disorder
* Chromosomal anomalies; and
* Congenital malformations were excluded from the study
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults with Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.


Eligibility Criteria:
Inclusion Criteria:

For subjects with LBCL:

* Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
* At least 1 measurable lesion at time of enrollment
* Relapsed or refractory disease after at least 2 lines of chemotherapy
* Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)

For subjects with CLL/SLL:

* Diagnosis of CLL/SLL
* Relapsed/refractory disease
* Subjects relapsed/refractory to BTKi therapy and high-risk disease
* Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax)
* At least 1 measurable lesion at time of enrollment

For all subjects:

* Male or female subjects ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hematological, renal, and liver function

Exclusion Criteria:

* Active central nervous system (CNS) involvement by malignancy
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
* Any other active malignancies that required systemic treatment within 3 years prior to enrollment
* Radiation therapy within 2 weeks prior to ALLO-647
* Prior irradiation to \>25% of the bone marrow
* Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).
* Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
* Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses

The aim of this study is to determine whether eating breakfast or having no breakfast has subsequent beneficial health effects, specifically in relation to glycemic response throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6 hours after breakfast/lunch.

This will be a randomised, crossover study with two treatments in total. 1.) Subjects given with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for approximately 9 hour (spanning over 3 days), during which the following will take place: On Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be collected. Participants with breakfast treatment will then consume the test meal within 15 minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180 minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360 minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between visits.

Eligibility Criteria:
Inclusion Criteria:

* Chinese males
* BMI above 23.0 kg/m2
* Age between 40-65 years
* Normal blood pressure (\<140/90 mmHg)
* Fasting blood glucose of ≥5.6 mmol/L
* Self-reported regular breakfast consumers

Exclusion Criteria:

* Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* major chronic disease such as heart disease, cancer or diabetes mellitus
* taking insulin or drugs known to affect glucose metabolism
* Intentionally restrict food intake
* major medical or surgical event requiring hospitalization within the preceding 3 months
* Have taken antibiotics for 3 months before the study period
* Smoking
* Overnight shift workers
* Any known food allergy (eg. anaphylaxis to peanuts)
* Having active Tuberculosis (TB) or currently receiving treatment for TB
* Any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
* Being a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus

An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.

This study will investigate the prevalence of the metabolic syndrome in patients with SLE in Taiwan. We expect our study will provide further understanding of the association between SLE and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and mortality in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 18 and above.
* Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group.

Exclusion Criteria:

* Exclude a history myocardial infarction, angina or stroke.
Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a progressive genetic neuromuscular disease characterized by progressive loss of motor function, respiratory failure, and cardiomyopathy required regular physiotherapy. With the outbreak of the pandemic rehabilitation centers that make up the weekly physiotherapy routine of children with disabilities have slowed down or even stopped their activities. So DMD who have additional diseases such as respiratory muscle weakness, spinal deformity, obesity, and cardiac dysfunction have also been negatively affected. The 'telerehabilitation' method, which is well planned and prepared for the abilities and needs of patients and caregivers, is seen as a good option at this point.

Studies, reporting the feasibility and safety of telerehabilitation in joint replacement, multiple sclerosis, and post-operative conditions, report that the length of stay was reduced, there was access to the same level of service regardless of the distance, and there was no travel cost. Despite these advantages, the framework and applicability of telerehabilitation programs have been investigated limited and not focused on effectiveness of telerehabilitation in patients with DMD.

According to the current knowledge, telerehabilitation in DMD is a subject that needs to be investigated in terms of its benefits. So, in this study, it was aimed to show the telerehabilitation's feasibility and its effects on performance level, endurance, fall frequency, pulmonary functions, and satisfaction level with the program in individuals with DMD.


Eligibility Criteria:
Inclusion Criteria:

* Able to communicate verbally and visually,
* Older than 5 years old

Exclusion Criteria:

* Individuals who had undergone any surgical operations in the past 6 months,
* Had a severe cognitive and breathing impairment,
* Using mechanical ventilator continually or intermittent,
* Having febrile infection
The Effect of Body Shape on Tragus-Wall Measurement

Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis Metrology Index (BASMI). Being obese or slim may affect TWD. As well as the person's losing or taking weight may lead wrong evaluations, in comparative studies, according to the height or weight uneven distribution of groups may affect the results. The aim of this study is to investigate whether the body shape affect TWD or not.

Healthy volunteers between 18-65 ages who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities)will be included into the study. A wall corner will be used as the measurement platform; the evaluated person will be positioned as described in BASMI. A rigid ruler will be placed form anterior superior iliac spine (SIAS) to the lateral wall, parallel to the back wall; a projection point will be determined and its distance from back wall will be measured (SIAS-WD). In the same position, projection point of the middle of the humerus head and back wall distance (shoulder-WD) and TWD also will be measured. The relationships between these parameters will be statistically assessed.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 18-65 ages

Exclusion Criteria:

* subjects with disorders that may disturb posture or erect position
* inflammatory diseases,
* kyphosis,
* scoliosis,
* joint deformities
Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users

The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use.

This study will evaluate whether 2 weeks of rTMS can be used to decrease attentional bias to cannabis cues and reduce cannabis use in heavy cannabis users. We will recruit sixty (60) non-treatment seeking, near-daily cannabis users to receive 10 daily sessions of either real or sham (aka placebo) rTMS over a 2-week period. Participants will live on a residential research unit for 3 weeks. During the residential stay, data on cannabis use (measured using standard human laboratory measures of choice to smoke cannabis) and relevant brain activity (measured using drug cue exposure fMRI tasks) will be collected before and after the course of 10 daily rTMS sessions. We will aim to show whether real rTMS treatment reduces brain response and attentional bias to cannabis cues and reduces cannabis use levels.


Eligibility Criteria:
Inclusion Criteria:

* Males/non-pregnant females, 18-60 years old
* Current cannabis user
* Able to perform all study procedures

Exclusion Criteria:

* Use of other illicit drugs
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate

The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction.


Eligibility Criteria:
Inclusion Criteria::

* Pregnant women
* 18 years of age or greater
* Singleton pregnancy between 32-42 weeks gestation requiring labor induction
* Membranes must be intact

Exclusion Criteria:

* Ruptured membranes
* Gestational age less than 32 weeks
* Non-reassuring fetal heart rate tracing
MONITOR-IC Post ICU Care Study

* OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.
* RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?
* HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

* OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.
* RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?
* HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.
* STUDY POPULATION Adult patients at high risk of critical illness-associated morbidity post-ICU.
* INTERVENTION Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.
* USUAL CARE / COMPARISON No or unstructured post-ICU care.
* OUTCOMES Primary: QoL and mental functioning 1-year post-ICU. Secondary: physical and cognitive functioning 1- and 2-year post-ICU, cost effectiveness and cost utility.
* FOLLOW-UP TIME One and two years post-ICU.
* STUDY DESIGN Stepped wedge cluster RCT in 5 hospitals.
* SAMPLE SIZE \& DATA ANALYSIS 5 ICUs (11 patients/ICU/month, in total 770 intervention patients, and 1480 (active and historical) controls gives power of 87% to detect effect of 0.074 in EQ-5D (ICC 0.035; SD 0.26). Data will be analysed according to intention to treat principles, also per-protocol analyses will be performed.
* COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Comparison of 'cost per QALY' gained between patients in the intervention and control group. Decision analytical modelling will be used to calculate the average savings per patient; extrapolated to population level using a budget-holders perspective.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients at high risk of critical illness-associated morbidity post-ICU
* 18 years or older
* Patient or legal representative understands the Dutch language

Exclusion Criteria:

* Patients discharged from ICU/hospital direct to a nursing home
* Patients discharged from ICU/hospital direct to a medical or geriatric rehabilitation clinic
* Patients discharged for palliative care