cyrilzakka/clinical-trials huggingface dataset:
RESTART C0168Z05 Rheumatoid Arthritis Study

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have rheumatoid arthritis
* Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
* Patients must have inadequate disease response to etanercept or adalimumab
* Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Exclusion Criteria:

* Patients who have a history of latent or active TB
* Have inflammatory disease other than rheumatoid arthritis
* Have had a chronic or recurrent infectious disease.
Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest

This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).

The use of beta-blockers in OHCA patients with refractory VF could potentially reverse the unwanted beta-1-mediated effects of endogenous and exogenous epinephrine (proarrhythmic effect), which could in turn lead to a shorter time until return of spontaneous circulation (ROSC).

This is a prospective, double-blind, randomized placebo-controlled pilot trial. The investigators consider this a pilot trial, as this is the first prospective trial evaluating the use of beta-blockade in cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* OHCA , \>/=18 years of age
* 3 or more shockable rhythms (VF or pVT) and last rhythm shockable

Exclusion Criteria:

* Age \> 85a
* Severe head trauma or acute active bleeding
* Known allergy or insensitivity to landiolol or another beta-blocker
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.


Eligibility Criteria:
Inclusion Criteria:

* Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
* Taking full agonist opioid therapy for cancer related pain.
* Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
* Capable of completing paper questionnaires at the study visits.

Exclusion Criteria:

* Unable to eat or drink.
* Taking opioids for management of drug addiction.
* Unable to use only rescue laxatives provided.
* Inappropriately managed severe constipation that puts subject at risk of complications.
* Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
* Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.
Atacicept in Subjects With IgA Nephropathy

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

This is a multi-part study comprising of the original Phase 2b study (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting).

After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form
* Male or female of ≥18 years of age
* Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
* Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
* eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
* On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
* Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Key Exclusion Criteria:

* IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
* Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
* Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
* Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<30g/L in association with UPCR \>3.5 mg/mg
* Renal or other organ transplantation prior to, or expected during the study
* Concomitant chronic renal disease in addition to IgAN
* Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) \>7.5% at screening
* History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
* Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain

Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

The main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for MCS with an internal pulse generator (IPG) capable of delivering both tonic and Burst DR(TM) stimulation waveforms.

Exclusion Criteria:

* Patients under 18 years old ; pregnancy
Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.


Eligibility Criteria:
Main Inclusion Criteria:

* Age 18 - 80 years (both inclusive), male or female;
* Diagnosis of definite, probable, probable laboratory supported or possible ALS as based on the El Escorial and the revised Airlie House diagnostic criteria for ALS;
* Onset of first symptoms\* no longer than 24 months prior to randomization;

  \*Date of onset is the date the patient reported one or more of the following symptoms:
* Muscle weakness in limbs
* Speech/swallowing difficulties
* Respiratory symptoms: dyspnea was noticed
* SVC equal to or more than 70% of the predicted normal value for gender, height and age at screening visit;
* Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit;
* Capable of providing informed consent and complying with trial procedures.

Main Exclusion Criteria:

* Diagnosis of Primary Lateral Sclerosis;
* Diagnosis of Frontotemporal Dementia;
* Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease, Alzheimer disease);
* Diagnosis of polyneuropathy;
* Other causes of neuromuscular weakness;
* Have a significant pulmonary disorder not attributed to ALS and/or require treatment interfering with the evaluation of ALS on respiratory function;
* Use of intravenous (IV) edaravone within 6 months of the screening visit;
* Depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at Screening;
* Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation;
* Subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for HIV, hepatitis B or C;
Induced Gingivitis & Intra-oral Imaging

Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.

The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.

The intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. This study is a modification of classical experimental gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. The purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* In good general health, ASA I
* No clinical signs of gingival inflammation at \>90% sites observed
* Probing Depth(PD) ≤ 3.0 mm
* Attachment Loss (AL) = 0 mm
* Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on probing (BOP)(-)
* Fluent in English

Exclusion Criteria:

* • Medical condition which requires premedication prior to dental treatments/visits

  * Subjects unable or unwilling to undergo informed consent process.
  * Subjects currently using anti-gingivitis oral rinses (washout period of 1 week)
  * History of periodontal disease
  * History of systemic inflammatory or immune conditions
  * Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment
  * Pregnant or breastfeeding at time of screening
  * Concurrent orthodontic treatment
  * Untreated carious lesions and/or inadequate restorations, implants, crowns on maxillary non-molar teeth
  * Participation in any other clinical study or test panel within 1 week prior to enrollment into this study
  * Use of tobacco products
  * Subjects who must receive dental treatment during the study dates
  * Orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the non-molar maxillary teeth
  * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Machine Learning to Construct an Association Model for Lung Cancer and Environmental Hormone

To apply machine learning to construct an association model regarding lung cancer and environmental hormones to more comprehensively identify factors that may lead to lung cancer and to improve existing lung cancer nursing assessments.

The present study is exploratory, and its design was divided into three stages: Stage 1 explored the environmental hormonal risk factors for lung cancer and constructed an association model using machine learning algorithms. Stage 2 validated the results of the association model with better predictive results in clinical settings. Stage 3 involved recommendations for reconstructing nursing assessments based on the results of the clinical model validation. The three stages are summarized as follows.

Eligibility Criteria:
Inclusion Criteria:

1. 20 years or older;
2. conscious, without mental disorders;
3. able to use Mandarin to communicate, had a smartphone or tablet computer and could operate it by themselves,
4. and were willing to participate in the study after the reasons for participation were explained and a consent form was signed, indicating their consent.

Exclusion Criteria:

* The exclusion criteria were those who could not understand the content of the nursing assessment questions and those with mental disorders.
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. Motion is defined as controlled rubbing or tapping of the subject's fingers in a 2-4 Hz or random sine motion with 2-3 cm amplitude.

Eligibility Criteria:
Inclusion Criteria:

* Good general health with no evidence of pre-existing medical problems
* Fluent in both written and spoken English
* Must be able to review informed consent and is willing to comply with study procedures

Exclusion Criteria:

* Obesity (BMI \>30)
* Known history of heart disease, lung disease, kidney or liver disease
* Prior diagnosis of asthma, sleep apnea, or use of CPAP
* Diabetes
* Clotting disorder
* Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
* Any serious systemic illness
* Current smoker
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
* History of fainting or vasovagal response
* History of sensitivity to local anesthesia
* Prior diagnosis of Raynaud's disease
* Unacceptable collateral circulation based on exam by investigators (Allen's test)
* Pregnant, lactating, or trying to get pregnant
* Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
* Any other condition which in the opinion of the investigators would make them unsuitable for the study
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature
Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care (AtrialConnect)

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a large consumption of health resources. Telemedicine represents a new model of care, facilitating the individual approach to each patient and reducing costs and complications.

This is an an open-label, randomized, multicenter, clinical trial aiming to analyze the use of telemedicine with AF patients in real clinical practice at primary care in terms of efficacy, efficiency, patient perception and professional satisfaction.

The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care. The follow-up will be carried out for 12 months.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a prevalence between 2-4%. Given the increase in prevalence, its associated morbidity and mortality, and the large consumption of health resources there has been a need to adapt health care models. Telemedicine and the use of mobile devices represent a new model of care for chronic patients, facilitating the individual approach to each patient and reducing the disability associated with their chronic pathology.

Objective: To analyze the use of telemedicine in patients with atrial fibrillation in real clinical practice in primary care trying in terms of efficacy (blood pressure control, incidence of ischemic stroke, incidence of bleeding), efficiency (number of visits to the clinic, hospitalizations, costs of care), patient perception (quality of life, therapeutic adherence, satisfaction with the mobile App) and professional satisfaction (satisfaction with the mobile App and benefits of its use in the clinic).

Methods: The investigators propose to conduct an open-label, randomized, multicenter clinical trial. The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care with their primary care physician (PCP). The control group will perform the usual follow-up with their PCP. The follow-up will be carried out for 12 months, and is proposed as an effective and cost-efficient improvement for the national health system and for the patient.

Key words: Telemedicine, Mobile Applications, Atrial Fibrillation, Primary Health Care.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age diagnosed with AF.
* Without difficulties in using the mobile App or patients with difficulties in using the mobile App but with good family or caregiver support, who understand its use.

Exclusion Criteria:

* Terminally ill patient.
* Refusal to participate on the part of the patient
* Difficulties in understanding the contents of the mobile App (cognitive impairment, dependence for activities of daily living, etc.) and no enabling family support
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide desensitising vaccine currently being developed for treatment of cat allergy.

At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years.
* Weight \>50 kg.
* A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
* Positive skin prick test to cat allergen.
* Subjects must have regular exposure to a cat in their normal living or working circumstances throughout the course of the study.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

* History of asthma
* History of anaphylaxis to cat allergen
* History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
* History of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis)