cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors

This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
* Subjects must have at least 1 measurable lesion.
* Consent to provide archived tumor specimens
* Willingness to undergo pre-treatment and on-treatment biopsy.
* Adequate organ function.
* Use of highly effective contraception (females) or male condom plus spermicide (males).

Exclusion Criteria:

* Prior treatment with TNFRSF agonists.
* Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.

  o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
* History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
* Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
* Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
* Unresolved toxicities from prior anticancer therapy.
* Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Healthy Volunteer Study Using 3 Different Formulations of Firategrast

This study will investigate how 3 types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.

The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose crossover fashion.

Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 18 to 65 yrs inclusive
* Healthy, as determined by study physician
* Capable of giving iformed consent

Exclusion Criteria:

* Positive drugs of abuse result
* Positive for HIV or Hepatitis B and/or C viruses
* History of alcohol consumption in excess of average recommended weekly intake (more than 12 units for males)
* Participation in a clinical trial within 30 days of scheduled first dose
A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics

Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly.

The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury.

The investigators will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested the investigators include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. The investigators will also measure the impact on the ED, and how much money could be saved if more paramedics were allowed to use the CCR. The investigators will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.

Paramedics in participating Ontario communities will all receive standardized training on the application of the Canadian C-Spine Rule (CCR). Once the training has been completed, paramedics will begin using the CCR to evaluate patients with potential c-spine injuries. For the first three months of the evaluation period, paramedics will use the CCR to evaluate eligible patients, but continue to use spinal immobilization for transport according to their existing protocols. After this validation period, participating services will be randomized in stepped wedge fashion in clusters of 4 services to actively use the CCR and selectively immobilize according to the CCR.

Eligibility Criteria:
Inclusion Criteria:

* Alert (Glasgow Coma Scale 15)
* Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute
* Acute blunt injury (within 48 hours of paramedic contact)

Exclusion Criteria:

* Age \<8 years of age
* Penetrating trauma from stabbing or gunshot wound
* Acute paralysis (paraplegia, quadriplegia)
* Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)
* Referred from another hospital
PDRI Rates Among CAPD Patients at a Tertiary University Hospital: A 5-Year Retrospective Study

Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection rates, causative pathogens, appropriation of antibiotic use, treatment outcomes and trend in antimicrobial resistance of causative pathogens.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were at least 18 years old.
2. Patients who were diagnosed with stage 5 chronic kidney disease (eGFR \< 15 ml/min/1.73m\^2).
3. Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital during January 1, 2016 to December 31, 2020.

Exclusion Criteria:

1. Patients with incomplete data records that invalid to include in the process of data analysis
2. Patients who were not treated and started their first CAPD at CAPD clinic, Phramongkutklao Hospital.
Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.

this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.

In the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease.

Hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease

Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms.

Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD, however DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. Therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease.

The investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease In according with Hoehn and Yahr scale (H\&Y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5.

Clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. All evaluations were performed in the morning, one hour after taking drugs. The assessment included: Unified Parkinson's Disease Rating Scale (UPDRS), for clinical evaluation, Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Freezing of Gait Questionnaire (FOGQ) and Abnormal Involuntary Movements Scale (AIMS) for motor symptoms evaluation and, finally, Parkinson's Disease Disability Scale (PDDS), for evaluation of the functional impact of the disease. Since in the advanced stages of PD one of the most troublesome complication includes cognitive disorders, a Neuropsychologist performed a cognitive assessment at the admission. The neuropsychological profile was explored using the Mini Mental State Examination (MMSE), a tool for screening of cognitive impairment, and the Frontal Assessment Battery (FAB) for the evaluation of frontal lobe dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

clinica diagnosis of Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological conditions
A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients (18 years)
2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria:

1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg)
4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply.
Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.

It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).

Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years old
* patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, EC-MPS or MMF +/- corticosteroids
* renal transplantation, at least 6 months prior study inclusion
* suitable and willing to switch treatment according to the study plan
* women of childbearing potential must have a negative serum pregnancy test before study start and effective contraception must be used (method with PEARL index \<1%)

Exclusion Criteria:

* patients with renal function \<30ml/min (estimated by Cockcroft Gault formula)
* patients who are not on stable treatment with enzyme inductors or enzyme inhibitors for \<1 month before study entry
* patients who take medication which is known for interfering with MPA absorption for \<1 month before study entry
* known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively
* patients on treatment with clopidogrel
* acute rejection \< 1 month before study inclusion
* patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive
* patients with gastrointestinal disorders which could affect resorption
* pregnancy and/or lactation
* drug or alcohol abuse in patient's history
* patients with history of psychological illness or condition, which might interfere with the ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent
* patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)
A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma


Eligibility Criteria:
Inclusion Criteria

1. Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:

   1. Serum M-protein level \> 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.
   2. Urinary M-protein excretion \> 0.2 g/24 hours by urine electrophoresis.
2. Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after \> 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
3. Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
4. ECOG performance score ≤ 1;
5. No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
6. Age ≥ 18;
7. Granulocytes ≥ 1.0 x 109/L; platelets ≥ 50 x 109/L;
8. Bilirubin ≤ 2.0 mg/dL; AST and ALT ≤ 2 x ULN;
9. Creatinine ≤ 3 X ULN.
10. No investigational agents within 28 days of study entry.
11. Males who agree to use a double-barrier method of birth control, (Double barrier method is defined as: a condom and either a diaphragm/cervical cap or an IUD).

Exclusion Criteria

1. NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
2. Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
3. Active infection requiring antibiotics;
4. Allergy to ZIO-101 or its excipients;
5. Baseline confusion or dementia, defined as grade \> 2 CTCAE Version 3.0;
6. Significant neurotoxicityneuropathology, defined as grade \> 2 neurotoxicity neuropathology per CTCAE Version 3.0;
7. Prior seizures ≥ grade-3 in CTC v.3 criteria.
8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ).

This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.

Problem: There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based PrEP and medications for OUD (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement.

Purpose: This study uses a newly validated decision aid and eHealth to remotely deliver integrated PrEP and MOUD to community-based WICJ with OUD in New Haven, Connecticut (CT) and Birmingham, Alabama (AL).

Methods: 250 PrEP-eligible WICJ with OUD will undergo randomization to: a) the "Athena" strategy, which includes the decision aid + eHealth for remote integrated PrEP/MOUD with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based PrEP/MOUD. Randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of MOUD. Follow-up study assessments occur at months 1, 3, and 6. To understand implementation, the investigators will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews.

Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care continua, considering key site differences; and 2) To assess scale-up potential of the Athena strategy in terms of modelled long-term outcomes and how stakeholders interact with eHealth for integrated PrEP/MOUD in WICJ in two diverse epidemiological and implementation contexts (CT and AL), using standardized definitions of implementation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* cis-women
* have access to a working mobile or landline phone
* Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail)
* are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test
* meet clinical criteria for PrEP
* have opioid use disorder (regardless of baseline treatment status)

Exclusion Criteria:

* unable or unwilling to provide informed consent
* pregnant or breast-feeding
* currently taking PrEP at the time of study enrollment
* not comfortable conversing in English or Spanish.
Exercise Prescriptions for Patients With Cardiovascular Disease

Physiotherapists are often confronted with patients with (elevated risk for) cardiovascular disease (CVD), even when this is not the primary indication for physiotherapy. Hence, physiotherapists should be able to provide evidence-based exercise advice to these patients, but this has not been assessed. The aim of this study was therefore to assess whether exercise prescriptions by physiotherapists to patients with CVD are in accordance with international recommendations.

In this prospective observational survey, forty-seven Belgian physiotherapists agreed to prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases. Exercise prescriptions were compared between clinicians and relations with clinician characteristics were studied. In addition, the agreement between physiotherapists' exercise prescriptions and those from international recommendations (based on a maximal score of 60/per case) was assessed.

Eligibility Criteria:
Inclusion Criteria: Currently professionally active Flemish physiotherapists

Exclusion Criteria: Not having access to a device that allows the use of the EXercise Prescription in Everyday practice \& Rehabilitative Training (EXPERT) tool.
A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points

Determine the effect of dry needling using a 32 gauge needle on active trigger points in subjects with chronic myofascial pain.

Participants will receive treatment for active trigger points (3 on successive weeks) and will have pain, status of the trigger point and functional measures assessed at baseline, after treatment and eight weeks later.

Chronic myofascial pain syndromes, such as pain associated with myofascial trigger points (MTrPs), are prevalent yet poorly understood. Our long-term goal is to determine the pathogenesis and pathophysiological mechanisms of chronic pain associated with trigger points, eventually leading to the development of objective diagnostic criteria and effective pain management strategies. We propose to achieve this goal using a new and unique integrative methodology combining microanalytic biochemical assays, ultrasound technology (imaging) and mathematical modeling. An additional component of the study plan is to learn if a standard treatment for MTrPs is associated with the biochemical and ultrasound changes we will be measuring This project has the following specific aims: 1) To understand the viscoelastic soft tissue neighborhood and vascular physiology of affected muscle at a macroscopic level using ultrasound imaging, elastography and Doppler blood flow imaging; 2) To understand the pathophysiology of myofascial trigger points at a nanotechnological level through assays of biochemical milieu using a microdialysis technique; 3) To develop mathematical models of underlying pathophysiological mechanisms based on experimental observations for quantitative hypothesis testing; 4) To determine if dry needle therapy, a standard of care for MTrPs, changes the macroscopic and/or microscopic measurements and leads to resolution of the trigger point and secondarily associated pain symptoms.. Our hypothesis is that pathogenesis of myofascial pain syndrome involves local trauma to the muscle fibers, and the biochemical response to the injury leads to sustained muscle contracture, compression of blood vessels and a local energy crisis that causes tissue hypoxia and the expression of pain-producing substances at myofascial trigger points. Relieving the trigger point through dry needle therapy

Eligibility Criteria:
Inclusion Criteria:

* spontaneous soft tissue pain in shoulder and neck region

Exclusion Criteria:

* recent fracture, neurological injury or history of stroke, use of opioids