cyrilzakka/clinical-trials huggingface dataset:
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

  * have not received any prior systemic anti-myeloma therapy AND
  * have measurable disease AND
  * are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old

Exclusion Criteria:

* Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
* Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
* Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Active plasma cell leukemia
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer

This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility Criteria:
Inclusion Criteria:

* invasive breast cancer
* stage I-IIIA disease
* ER, PR, Her2/neu-negative status
* no prior treatment for breast cancer
* age 18 years of greater
* normal renal, liver function
* normal hematologic status
* ECOG Performance status 0, 1
* Evaluation by a surgeon to determine breast conservation eligibility
* Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Metastatic breast cancer
* Inoperable breast cancer, including Stage IIIB and IIIC
* Tumor size less than 1 centimeter
* Prior surgery, systemic therapy, or radiotherapy for the current cancer
* Hormone receptor-positive breast cancer
* Her2/neu-positive breast cancer
* Any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Pregnant or nursing women
* Receipt of any investigational agents within 30 days prior to commencing study treatment
Reproducibility of Computed Tomography

Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph scan three-dimensional reconstruction method for the measurement of the TB pleural effusion volume in clinically stable patients.

Speed, accuracy, and precision in the quantification of pleural effusion are of critical importance as it determines whether or not thoracocentesis should be carried out and which technique should be employed for such a procedure. This study evaluates the precision of thoracic computed tomography with three-dimensional (3D) rebuilding in determining the volume of tuberculosis pleural effusion.Twenty patients with pleural effusion were screened and invited to take part in the study. Each patient underwent two computed tomography scans, before and after one month of treatment for tuberculosis, a total of 40 exams. These were evaluated by two expert radiologists. In conclusion, the quantification of the pleural effusion volume by using thoracic CT with volumetric three-dimensional reconstruction is a highly reproducible method.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years with a confirmed diagnosis of pleural TB effusion .
* Signed out an informed consent term

Exclusion Criteria:

* Patients with human immunodeficiency virus (HIV).
Cycling, Air Pollution and Health

Introduction: Cycling is currently promoted at the municipal, provincial and national level as a form of active transportation that increases physical activity while at the same time reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions. While at a population level the health benefits of exercise via cycling are estimated to substantially exceed any health impacts related to air pollution exposure and injuries from traffic accidents , cyclists are known to experience elevated exposures to traffic-related air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists also are subject to substantially increased inhaled doses due to their level of exertion and consequently increased inhalation rate. Therefore, given that cyclists experience exposures to relatively high concentrations of traffic-related air pollutants and that their inhalation of these pollutants is increased, it is important to evaluate the potential health impacts of this scenario. Research on the potential health impacts related to exercise (cycling) and urban air pollution exposure can help inform public communication strategies related to air quality and its health impacts. In addition, as our previous work suggests substantial variability in air pollution exposures to cyclists that is related to the route type and the levels of traffic along cycling routes, there is potential for transportation planners to promote increased cycling by enhancing infrastructure while at the same time developing routes that also minimize exposure to air pollution. The cyclist population is also interested in information regarding the air pollution exposures and potential health impacts related to cycling.

The objective of this study is to investigate the relationship between traffic-related air pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists. Specifically, the investigators propose to:

1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10, ultrafine particulate, black carbon) while cycling along two different bicycle routes in the city of Vancouver;
2. estimate the pollutant dose received by each cyclist, and relate this to the health effects observed; and
3. determine if there is a change in lung function, endothelial function, and C-reactive protein level related to the level of air pollution exposure and dose


Eligibility Criteria:
Inclusion Criteria:

* Age 19- 39
* male or female
* able to bicycle comfortably on city streets for 1 hour

Exclusion Criteria:

* Smokers of any substance (smoking more than 1x every 2 weeks)
* Must be of height to safely ride a test bike (\<5'2", \>6'5" )
* Diagnosed asthma or active allergy (hav fever) symptoms
* Irregular menstrual cycle, pregnant, breastfeeding, non-monocyclic contraceptive medication or device
* Taking medication for heart or lung condition
* Answers yes to any questions on physical activity readiness questionnaire (PAR-Q)
* requires pain medication daily
* visual or hearing impairment that prevents safe cycling on streets with motor vehicles
Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)

A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)

The overall purpose of this study is to assess the feasibility of conducting a 9-week integrative medicine program that is comprised of a prescribed anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS), in order to determine the recruitment potential in this population and to measure the ability of individuals to complete the program. Participants will be prescribed a food plan, and adherence to and feasibility of the food plan will be measured through participant food tracking and a subjective assessment of the food plan in a brief satisfaction survey.

This study aims to recruit 20 patients with HSD or EDS and make preliminary observations regarding the effects of integrative medical care on pain reduction and improved quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Beighton score of 4 or more to confirm joint hypermobility diagnosis
* Baseline VAS Score of 1 or more
* Not currently, or already a patient of Dr. Schaefer and Healthy Living Community
* Ability to provide written informed consent
* Willingness to participate in 9-week integrative medicine intervention (and make dietary and lifestyle changes)
* Willingness to attend 1 in-person screening visit and 2 virtual office visits (or 3 virtual visits, if medical documentation of Beighton score can be provided in advance of enrollment, and all other criteria are met)
* Access to an electronic device for MyFitnessPal food-tracker use (i.e mobile device, tablet, laptop)

Exclusion Criteria:

* Pregnant and lactating women, or planned pregnancy over the next 3 months
* Consumption of more than 14 (men) or 7 (women) alcoholic drinks per week
* History of disordered eating or eating disorder
* Body mass index (BMI) considered underweight (\<18.5)
* Weight loss from metastatic cancer
* Unable to make dietary changes or participate in a 9-integrative medicine nutritional intervention
* Those with significant dietary changes, new medications, or new exercise routines within the past 90 days
* Currently, or already, a patient of Dr. Schaefer and Healthy Living Community
Effectiveness of Acetazolamide for Reversal of Metabolic Alkalosis in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

The purpose of this study is to determine whether acetazolamide is effective to reduce the length of mechanical ventilation in decompensated COPD patients developing pure or mixed metabolic alkalosis.

Eligibility Criteria:
Inclusion Criteria:

* Decompensated COPD on invasive mechanical ventilation Less than 24 hours
A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.

A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.

Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.

Eligibility Criteria:
Inclusion Criteria:

* Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period.
* A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
* Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
* Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.

Exclusion Criteria:

• Child in care.
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
* Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
* Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion Criteria:

* Subjects with other rheumatic diseases
* Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
* Any prior use of B cell-depleting therapy
An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia

To validate the efficacy and safety of azithromycin for the treatment of Chinese patients hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Patients hospitalized with a diagnosis of community acquired pneumonia (CAP) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest X-ray with or without pleural effusion plus at least 1 of the following: new cough and expectoration or progression of respiratory symptoms with purulent sputum with or without chest pain; fever; auscultatory findings such as rales or evidence of pulmonary consolidation; blood leukocyte count \>10×109/L or \<4×109/L with or without \>15% bands or a blood leukocyte count between 4 and 10 with neutropils greater than or equal to 75%

Exclusion Criteria:

Exclusion Criteria:

* Patients with hospital acquired pneumonia, aspiration pneumonia, severe pneumonia, history of post-obstructive pneumonia, active tuberculosis or bronchitis, bronchiectasis or chronic obstructive pulmonary disease without evidence of acute infection were not eligible for this study
* Patients treated with any systemic antibiotic within 72 hours prior to study entry were not eligible unless the medication was, in the opinion of the investigators, classified as having failed
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation

The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.

The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
* Diagnosis of NVAF
* Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
* Treatment naïve regarding stroke prevention for atrial fibrillation
* Signed informed consent

Exclusion Criteria:

* Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
* Patients participating in an investigational program with interventions outside of routine clinical practice
Analysis of the Motion Activity Manual Wheelchair Users

Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. in 2017, and in light of the scientific literature related to wheelchair propulsion, it would seem appropriate to validate the use of inertial units as tools to quantify and categorize the intensity of manual wheelchair propulsion.

The investigator hypothesize that an inertial unit positioned on the wheelchair wheel has the same detection rate of the propulsion cycle as a dynamometric wheel (step 1). In addition, the investigator hypothesize that the categorization of the detected propulsion cycle as a function of force intensity is similar between the angular deceleration of the wheel during propulsion calculated from the inertial unit and the external mechanical power calculated from a dynamometric wheel (step 2).

Eligibility Criteria:
Inclusion Criteria:

For the healthy user group volunteers:

* Men or women over 18 years of age,
* An experience of at least 2 hours using the manual wheelchair,
* Subject who has signed an informed and written consent,
* Affiliation to a social security system.

For the spinal cord injured user group:

* Men or women over 18 years of age,
* Injured Medullary users of manually propelled wheelchairs for daily locomotion (at least 30/100 at WST on travel items),
* Subject who has signed an informed and written consent,
* Affiliation to a social security system.

Exclusion Criteria:

* Patient refusing to participate in the study,
* Manual wheelchair users with propulsion assistance system,
* Major cognitive disorders,
* Unbalanced cardiovascular disease,
* Pressure sores and unhealed palm lesions,
* Asthma to effort,
* Progressive etiologies: tumor, infectious, inflammatory and associated - - pathologies: head trauma, amputation,
* Patient under guardianship or curatorship,
* Pregnant or breastfeeding woman.
The Effect of Motor Imagery Dosage on Motor Learning in Healthy Adults

The goal of this clinical trial is to compare the effects of different durations of Motor Imagery (MI) practice and physical practice on motor performance enhancement in healthy adults. The main questions it aims to answer are:

* Does Motor Imagery (MI) practice improve motor performance?
* How do different doses of MI practice (low vs. high) compare to no MI practice in enhancing motor performance?

Participants:

* Be randomly assigned to one of three groups: no MI practice (control group), low dose MI practice (6 minutes per session), or high dose MI practice (12 minutes per session).
* Complete nine sessions over three weeks, practicing a timed mirror tracing task.
* Have their performance measured in each session by the time taken to complete the task and the number of errors made.

Compared the control group, low dose MI group, and high dose MI group to see if there are significant differences in motor performance enhancement, aiming to determine the effectiveness of MI and the optimal dose for practice.


Eligibility Criteria:
Inclusion Criteria:

* no history of motor dysfunction, coordination disorders, or surgical procedures in the past 6 months
* scored 4 or less on the Movement Imagery Questionnaire (MIQ) on the non-dominant hand.

Exclusion Criteria:

* Played the target task in the past 6 months
* Subjects were ambidextrous
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders

The purposes of this study are to identify persons with rapid-onset dystonia-parkinsonism (RDP) or mutations of the RDP gene, document prevalence of the disease, and map its natural history.

Rapid-onset dystonia-parkinsonism (RDP) is a rare, movement disorder with variable characteristics ranging from sudden onset (hours to days) of severe dystonic spasms to gradual onset of writer's cramp. RDP has elements of both dystonia and Parkinson's disease-two neurological diseases with motor and neuropsychological symptoms that hinder the quality of life. An internal trigger associated with extreme physiological stress has been reported prior to abrupt symptom onset of RDP.

This study, which is a continuation of an earlier study begun by Dr. Allison Brashear, aims to more clearly identify the characteristics associated with RDP and to explore whether mutations in the RDP gene are associated with atypical dystonias, Parkinson's disease, and other movement disorders.

The study involves in-person or remote (telemedicine) neurological assessments and blood samples for genetic analysis.

Eligibility Criteria:
Inclusion Criteria:

* clinical presentation consistent with ATP1A3 disease (RDP, AHC) or confirmed diagnosis of RDP or AHC

Exclusion Criteria:

* none
A Photodynamic Therapy for Treatment of Actinic Keratoses

The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

Eligibility Criteria:
Inclusion Criteria:

Age greater than or equal to 18 years

* Have a t least 4 nonhypertrophic AK lesions on the body
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

Exclusion Criteria:

* Subjects who are pregnant or lactating
* Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
* Subjects with use of photosensitizing drugs within 1 week of study start
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects with systemic steroid therapy within 4 weeks before study entry
* Subjects who received previous treatment of target AKs
* Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
* Subjects with prior history of hypersensitivity reactions to lidocaine
* Subjects who are unable to understand the protocol or to give informed consent