cyrilzakka/clinical-trials huggingface dataset:
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy

RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment.

PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.

OBJECTIVES:

Primary

* To determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pCR).

Secondary

* To determine if the combined measurement of change in tumor ADC value, change in tumor volume, and change in peak signal-enhancement ratio (SER) is predictive of pCR.
* To investigate the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak SER for predicting pCR in experimental treatment arms.
* To assess the test-retest reproducibility of ADC metrics applied to breast tumors.

OUTLINE: This is a multicenter study.

Patients undergo diffusion-weighted magnetic resonance imaging (DWI) at baseline, after week 3 of neoadjuvant paclitaxel regimen, and prior to and after completion of 4 courses of neoadjuvant chemotherapy. Patients then undergo surgery. Patients undergo DWI prior to contrast administration for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

After completion of treatment procedure, patients are followed up for 5 years on the I-SPY 2 TRIAL.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets I-SPY 2 TRIAL inclusion criteria

  * High-risk for recurrent disease

PATIENT CHARACTERISTICS:

* Able to tolerate imaging required by protocol

PRIOR CONCURRENT THERAPY:

* Not specified
Efficacy and Safety of Pediatric Drugs in Nasal Congestion

The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.

Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
* Signed Consent;
* Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
* Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
* Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).

Exclusion Criteria:

* Participation in clinical trial in the year prior to this study;
* Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
* Infectious bacterial-disease (clinically diagnosed);
* Participants treated with antibiotic or possible antibiotic use due to another medical condition;
* Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
* Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
* Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
* Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
* History of hyperthyroidism or hypertension;
* History of hypersensitivity to the components of the study drugs;
* History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
* Exclusive mouth-breathers patients;
* Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
* History of alcohol and / or drug abuse 3 months prior to the study;
* Smokers
* Pregnancy or risk of pregnancy and lactating patients;
* PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.
A Better Everyday Life Among Persons With Chronic Conditions

Background: Persons living with chronic conditions often have decreased ability to perform Activities of Daily Living (ADL) tasks, stressing a need to develop and evaluate intervention programs addressing decreased ADL ability. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the program "A Better everyday LifE" (ABLE), a home-based intervention program, was developed and feasibility tested. The current phase concerns a full-scale evaluation of the ABLE program including evaluation of effectiveness, processes and cost-effectiveness.

Material and Methods: The design involves a randomized controlled trial, initiated with an internal pilot. The study will include eighty (n=80) home dwelling persons living with chronic conditions, experiencing problems performing ADL. Participants are randomized to either intervention (ABLE) or control (usual care).

Co-primary outcomes are self-reported ADL ability measured using ADL-Questionnaire (ADL-Q) and observed ADL motor ability measured using Assessment of Motor and Process Skills (AMPS). Secondary outcomes are perceived satisfaction with ADL task performance measured using ADL-Q; observed ADL process ability measured using AMPS; and Goal Attainment measured using Goal-Attainment-Scaling (GAS). Data is collected at baseline, post intervention and six months after baseline. Process evaluation data are collected using registration forms and semi-structured qualitative interviews.

The economic evaluation will be performed from a health care sector perspective with 6 months follow-up. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL ability.

Due to the Covid-19 pandemic, the study was truncated on March 11th 2020. Data collected at this time was assessed to be sufficient to answer most pilot study questions, and it was decided to turn the internal pilot into an external pilot. Based on the results of the external pilot, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual care were applied, before initiation of the full scale trial. Hence ADL-I replaced ADL-Q as primary outcome measurement. Data collection for full scale trial was initiated August 1st 2020.

Eligibility Criteria:
Inclusion Criteria:

* ≥ one year since medical diagnosed with one or more chronic conditions
* Perceive problems performing ADL tasks
* ≥ 18 years of age
* Lives in own home
* Motivated and ready for making changes in ADL performance
* Motivated and ready to participate in program
* Communicates independently and relevant
* Able to understand and relevantly answer a questionnaire

Exclusion Criteria:

* PADL problems with acute need for help (if the client does not already receive help from home carer
* Known substance abuse
* Mental illness, and/or other acute illness effecting ADL task performance
* Communication barriers (e.g. severe cognitive deficits; and barriers that prevents receiving information on study)
L-Citrulline and Endothelial Function

The effect of L-Citrulline is well studied in relation to muscle strength, exhaustion, exercise performance, and endothelial function in health and disease. This study will extend current body of knowledge and will investigate the effect of L-Citrulline on brain vascular function.

Endothelial function is associated with nitric oxide (NO) availability for vasodilation, blood pressure and blood flow regulation, and vascular health. A large body of evidence demonstrates that aging is associated with a decrease in bioavailability of NO, with more pronounced decrease in sedentary individuals. NO can be produced via the NO synthase (NOS) enzymes, which catalyze the conversion of L-Arginine - a semi-essential amino acid found in fish, nuts and legumes amongst others - to L-Citrulline and produce NO as an endproduct. While the effect of L-Citrulline is extensively studied in relation to muscle strength, exhaustion, exercise performance, as well as on endothelial function in healthy and diseased individuals (including obese and those with heart failure), the effect of L-Citrulline on brain vascular function is not well studied.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-45 and ≥55-90 years of age
* Adequate hearing and visual acuity to participate in the examinations
* Ability to read and write in English
* Competence to provide informed consent

Exclusion Criteria:

* Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
* Cerebrovascular accident other than TIA within 60 days prior to Visit 0
* Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
* Treatment with other Citrulline enhancers (L-Arginine, L-Citrulline Malate) within 4 weeks prior to Visit 0
* Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol
Fibrinogen as an Alternative to FFP in Aortic Surgery.

Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease.

Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results.

20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective thoracoabdominal aneurysm repair.
* Over 18 years of age.
* Able to give written informed consent.

Exclusion Criteria:

* Previous aortic surgery (re-do surgery).
* Emergency surgery.
* Pregnancy.
* Females of child-bearing age (less than 45 years) not using medically approved method of contraception.
* Congenital or acquired coagulopathy.
* Known allergy to study drug.
Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery

NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter activity of NFKB1 and several clinical diseases, but the clinical results cannot always be replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this polymorphism remains controversial. This study was performed to investigate the association of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery with CPB.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Han unrelated population
* undergoing elective cardiac surgery with CPB

Exclusion Criteria:

* malignant tumor
* autoimmune disease, immunodeficiency or immunosuppressive therapy
* chronic renal disease (glomerular filtration rate \< 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification\>A)
* COPD, tuberculosis or other chronic pulmonary diseases
* anemia with hemoglobin lower than 90mmHg
* bleeding disorders
* postoperative pericardial tamponade requiring re-operation
* postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.
n-CPAP Versus n-BiPAP and NIPPV for Postextubation in RDS in Preterms

non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV

The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants lessthan 34wk

Exclusion Criteria:

* preterms less than 1000 g birth weight
* infants with apgar 0at 1 min
* presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations
Chloroquine as a Modulator of T Cell Immune Activation

This study will evaluate the effect of chloroquine in individuals infected with HIV. Researchers will aim to determine if chloroquine treatment in participants whose viral loads are suppressed on combination antiretroviral therapy (ART), results in improved immune activation and CD4 cell recovery.

The study will recruit 20 individuals and will last approximately 44 weeks. Eligible participants will receive an oral dose of chloroquine (250 mg) once daily from week 8 through week 32. All participants will be asked to have rectal biopsy samples (week 0 and week 32) to study T cell immune activation in the mucosa rectal site.

Clinical data has identified chloroquine as a potential modulator of immune activation. The study's dose of chloroquine is the same as the dose recommended for patients having autoimmune diseases. In these autoimmune cases, a daily dose of chloroquine at 250 mg for 12 weeks has shown improvement in symptoms and decreases in inflammatory cytokines synthesis and a reduction in TLR -mediated immune activation. Study findings could help provide information about where and under what circumstances chloroquine treatment may reduce T cell activation and help restore circulating CD4 T cells.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection by Western Blot, EIA assays or viral load assay.
* Aged between 18 and 65 years.
* Viral load less than 50 copies per ml for at least the previous 36 weeks.
* CD4 cell count less than or equal to 350 cells per litre.
* On stable ART
* Vital signs, physical examination and laboratory results do not exhibit evidence diseases such as advanced cirrhosis or advanced liver
* Karnofsky performance status greater than or equal to 80 per cent.
* Participant does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with chloroquine.
* Able to give informed consent.

Exclusion Criteria:

* Active AIDS events in the last 3 months
* Co-infection with active hepatitis B or C virus.
* Current use or use within four weeks prior to the baseline visit, of cytotoxic agents, systemic corticosteroids or any immuno-modulatory agents.
* Current use within four weeks prior to the chloroquine therapy the following medications: methadone, chlorpromazine, cimetidine, cyclosporin, methotrexate and penicillanime.
* Psychiatric or cognitive disturbance or illness that could preclude compliance with the study.
* Patient with clinically significant hemophilia and Von-Willebrand disease and any severe bleeding disorder.
* Experimental HIV immune based therapy within 6 months of screening visit.
* Allergic reaction to chloroquine.
* A history of retinitis or any retinal problem.
* Subjects with G6PD deficiency, porphyria, psoriasis, cirrhosis, hearing deficiency (including tinnitus), myopathy and cardiomyopathy.
* Pregnant and breast-feeding women.
Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Eligibility Criteria:
Inclusion Criteria:

* ECOG score of 0 to 1
* Newly diagnosed Ph-negative B-ALL within 6 months, achieving CR1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and patients with bone marrow MRD ≥ 0.01% detected by routine flow cytometry.
* Or newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or use of TKI), undergoing at least one consolidation therapy, and patients with BCR-ABL1 \&amp;gt; 0% detected by routine q-PCR technology.
* No significant organ dysfunction
* Willing and meet the conditions for autologous hematopoietic stem cell transplantation

Exclusion Criteria:

* Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase.
* Before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia.
* Individuals who have received CAR-T cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation.
* Patients with associated genetic syndromes related to bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
High Intensity Laser Therapy in Carpal Tunnel Syndrome

This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and it causes numbness and tingling in the hand, atrophy and muscle weakness in the later stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel may increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. In majority of cases, no cause can be found and it is called "idiopathic".

While the diagnosis of CTS is made by the patient's history and physical examination methods, the diagnosis is confirmed with use of electrophysiological examination. Physical therapy, non-steroidal anti-inflammatory drug use, local steroid injection, hand-wrist rest splint, nerve/tendon gliding exercises; Physiotherapy modalities such as therapeutic ultrasound and laser are among the conservative treatment methods of CTS. Despite the effectiveness of surgery in the treatment of severe CTS cases, as is known, surgical treatment is not without risk. Therefore, mild to moderate CTS is treated conservatively.

Laser therapy is one of the physical therapy modalities, low-intensity laser therapy (LILT), whose biological effects occur secondary to direct photochemical effect and are not the result of thermal effects. High-intensity laser therapy (HILT), which has been widely used recently, is frequently used since it has small and slow light absorption from chromophores. HILT is not a concentrated light, but it diffuses in all directions (scattering phenomenon). This supports the wider effectiveness of HILT. HILT also has effects such as increased mitochondrial oxidative reactions, increased production of adenosine triphosphate, RNA and DNA (photochemical effect), increased tissue stimulation (photobiological), and reduced pain and inflammation. HILT, which has recently found many uses in musculoskeletal diseases, can affect a wider and deeper area in the tissues compared to the widely used LILT. Although there are many studies on the effectiveness of LILT therapy in CTS, there are few trials to study the effectiveness of HILT on clinical and electrophysiological parameters in CTS.

This investigation is designed as double-blind prospective sham controlled randomized study.

Participants were randomized into 2 groups: 1) HILT + nerve/tendon gliding exercises + rest splint and 2) Sham HILT+ nerve/tendon gliding exercises + rest splint

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate idiopathic carpal tunnel syndrome (clinically diagnosed and electrophysiologically confirmed CTS)

Exclusion Criteria:

* Diabetes mellitus,hypothyroidism, rheumatic diseases, acromegaly
* Polyneuropathy,
* Ipsilateral brachial plexopathy and traumatic nerve injury of the upper extremity
* Previous injection into the carpal tunnel and physical therapy within in the preceding 6 months
* Pregnancy
* History of malignancy
* Patients with cochlear implants