cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for RA
* RA disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (\>=) 6 tender/painful joints on motion (68 joint count) and \>= 6 swollen joints (66 joint count) at both screening and Day 1 (randomization)
* For MTX-inadequate response (IR) participants: must have had an inadequate response to MTX
* For TNF-IR participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor
* High sensitivity C-reactive protein of \>= 0.400 milligrams per deciliter (mg/dL) for Cohort 1 and \>= 0.650 mg/dL for Cohort 2 at screening

Exclusion Criteria:

* History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
* For MTX-IR participants: History of treatment with any TNF inhibitor, including biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor for RA
* For all participants: Previous treatment with cell-depleting therapy including B cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents
* Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
* History of non-gallstone-related pancreatitis or chronic pancreatitis
* Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease
* Evidence of chronic and/or active hepatitis B or C
* Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study
Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy (Carboplatin plus Etoposide) compared with treatment with Chemotherapy (Carboplatin plus Etoposide) alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Participants will be divided in a 1:1 ratio to receive either Atezolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide followed by radical surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures.
2. Histologically or cytologically confirmed stage IIb-IIIb SCLC.
3. Patients with good physical condition and good organ function.
4. Previously untreated patients.
5. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
6. Patients can tolerate chemotherapy, immunotherapy, and surgery.

Exclusion Criteria:

1. Unclear diagnosis of SCLC.
2. Contraindicated chemotherapy, immunotherapy, and surgery.
3. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
4. Positive test result for human immunodeficiency virus (HIV).
5. Positive test result for active tuberculosis.
6. Pregnant or lactating women
7. A history of psychotropic substance abuse, drug abuse, or alcoholism.
8. Other factors assessed by the sponsors.
The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease

The aim of this study was to compare the effects of pilates training and elastic taping on balance and postural control in early Parkinson's patients.

The subjects were randomly divided into 3 groups as pilates, elastic taping and waiting list control group. Individuals were given 60-minute pilates training twice a week for 6 weeks. In addition to Pilates training, elastic taping was applied twice a week for postural correction of the back. Individuals were evaluated for balance and postural control before and after training. Evaluation of clinical balance with Berg Balance Scale and Trunk Impairment Scale; Stability Limits, Sits Up, Normal and Tandem Walking Tests were performed with NeuroCom Balance Master balance and performance system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson Disease
* Mini Mental Test Score≥24
* Modified Hoehn and Yahr Score≤2
* Ability to stand 1 minute independently
* Ability to walk 10 meters

Exclusion Criteria:

* Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
* Unstabl cardiovasvularly disease
* History of Surgery about Parkinson disease
Fitbit for Postoperative Ambulation

This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.

Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and general post-operative complications. Ambulation is also a main tenant of a fast-track recovery protocol known as Enhanced Recovery After Surgery (ERAS), which is commonly used among colorectal surgical practices and being implanted across other surgical practices. Despite evidence supporting its benefit, early ambulation has been identified as the one of the most difficult clinical interventions to enforce and to measure.

The primary objective of this trial is to investigate whether the use of wireless activity tracking device (Fitbit) with 5 daily reminder alarms will increase daily ambulation on postoperative day 0 until post operative day 9 or hospital discharge (whichever occurs first). Secondary objectives include evaluating the effect of Fitbit as a motivating factor on the frequency of postoperative ileus, time to return of bowel function, number of venous thromboembolism (VTE), pneumonia (PNA) and other pulmonary complications, number of code Medical Emergency Team (MET) alerts, and overall cost saving.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing an elective surgical procedure in colorectal services at Emory University Hospital

Exclusion Criteria:

* Post-surgical admission into the intensive care unit (ICU)
* Have an open abdomen due to surgical complications
* Wound Vacuum Assisted Closure (VAC) dependent
Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are:

* Successful nasal intubation at the first attempt without physiological instability.
* Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia.

Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.


Eligibility Criteria:
Inclusion Criteria:

* Any neonate at the Department of Neonatology of the University Hospital Zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit.

Exclusion Criteria:

* Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of NIPPV, e.g. active cardiopulmonary resuscitation.
* Contraindication to NIPPV use (e.g. congenital diaphragmatic hernia, abdominal wall defects).
* Oral intubation planned.
* Denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
* Withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.
Serranator POINT FORCE Registry

The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.


Eligibility Criteria:
Inclusion Criteria:

* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
* Age of subject is \> 18.
* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.

Exclusion Criteria:

* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions

The research study, "Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions" will test two smoker-driven, social marketing innovations to recruit and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective "Digital Intervention for Smoking Cessation".

S2S has many innovations that are designed to utilize the power of peers and social networks for dissemination. These include: Peer recruitment: Tools to facilitate smokers' recruiting their peers to increase Decide2Quit access; and a recommender computer tailored health communication (recommender CTHC): a Complex machine learning algorithm (recommender systems) that uses smokers' feedback (explicit and implicit) in the current and prior studies to adapt its selection of messages to smokers.

Using a 2×2 factorial design, the study will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of Age or older
* Current smoker

Exclusion Criteria:

* Under 18 years of age
* Non-smoker
Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.

Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.

In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.

Eligibility Criteria:
Inclusion Criteria:

* Episode of depression (unipolar or bipolar)( ICD-10)
* Female or male between 18 and 70 years
* Skills to participate in all study procedures
* 18 or more points in the Hamiliton rating scale or depression
* Stable antidepressant drugs
* Written informed consent

Exclusion Criteria:

* Clinically relevant unstable internal or neurological comorbidity
* Evidence of significant brain malformations or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorders affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Epilepsy or a pathological EEG
* Heart pacemaker
* High dose tranquillizers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18～70yrs
* Signed informed consent
* Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
* Karnofsky score ≥70
* Life expectancy \>3 months
* WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
* Normal coagulation function, no evidences of hemorrhage
* Normal liver, heart, kidney function

Exclusion Criteria:

* Pregnant or lactating females
* Proven active infectious diseases (e.g. viral hepatitis, TB)
* Not adequately controlled infections
* Known hypersensitivity to filgrastim or any other components of the study drug
* Unstable or uncontrolled cardiac disease or hypertension
* Currently participated in any other clinical trials
* Patients with previous or expected to receive systemic radiotherapy
* Evidence of metastatic disease in bone marrow, brain, et al
* Alcoholic or drug abusers
* Other conditions which in the opinion of the investigator preclude enrollment into the study
Explore the Performance of IntelliCap.

This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.

The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged between 18 and 50 years of age, inclusive.
* Subjects with a body weight of at least 50 kg and no more than 100 kg, inclusive.
* Subjects with a body mass index (BMI) of 18 - 30 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* Subjects with suitable veins for cannulation or repeated venepuncture.
* Subjects must be available to complete the study.
* Subjects must satisfy a medical examiner about their fitness to participate in the study.
* Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Abnormal vital signs, after 10 min supine rest, defined as any of the following:
* Systolic blood pressure \< 100 mmHg or ≥ 140 mmHg.
* Diastolic blood pressure \< 50 mmHg or ≥ 90 mmHg.
* Heart rate \< 50 or \> 85 beats per minute.
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG.
* History of severe allergy/hypersensitivity or on-going clinically important allergy/ hypersensitivity as judged by the Investigator or known hypersensitivity to metoprolol (including other beta-blockers) or any other component of the product.

  •Plasma donation within one month of screening or any blood donation/blood loss greater than 500 mL during the three (3) months prior to screening.
* Receipt of a new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that includes drug treatment within at least three (3) months of the first administration of study treatment in this study. The period of exclusion begins three months after the final dose. Note: subjects consented and screened, but not randomised in this study or a previous phase I study, are not excluded.
* Previous randomisation to treatment in the present study.
* Involvement of any CRO/third party contractor or AZ employee and their close relatives regardless of their role.
* Judgement by the Investigator that the subject should not participate in the study if they have any on-going or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
* Subjects who cannot communicate reliably with the Investigator.
Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT

Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines.
* Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
* Patient with paroxysmal AF should have \>25% burden or inadequate biventricular pacing (\<95%) based on device counters.
* The patient is willing and able to comply with the protocol and has provided written informed consent.
* Age ≥ 18 years

Exclusion Criteria:

* Documented left atrial diameter \> 6 cm (parasternal long axis).
* Longstanding persistent AF longer than 2 years.
* Contraindication to chronic anticoagulation therapy or heparin
* Previous left heart ablation procedure for AF
* Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment
* Untreated hypothyroidism or hyperthyroidism
* Enrolment in another investigational drug or device study.
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
* Mental or physical inability to participate in the study.
* Listed for heart transplant.
* Cardiac assist device implanted.
* Planned cardiovascular intervention.
* Life expectancy ≤ 12 months.
* Uncontrolled hypertension.
* Requirement for dialysis due to terminal renal failure.
* Participation in another telemonitoring concept
Acute Pain Assessment Using Facial Expression Analysis

Managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. Evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. In these cases, pain can only be evaluated by medical staff by the observation of pain-related characteristics like facial expression of pain (FEP). However, recognition of FEP is subjective, time-consuming and subject to multiple biases frequently leading to underestimation of pain and consequently under-treatment. Some of these biases could be solved by the use of facial recognition technology, allowing objective, automated and time-saving pain assessment. DEF-I aims to address technical issues and achieve the development of facial expression recognition digital tool able to evaluate severe acute pain in clinical practice, with high validity and utility by improving the quality of the images to be analyzed, by studying larger samples of patients, data and images, in order to correlate more efficiently the pain intensity felt by a patient with the expression of his face. The main objective of this study is to verify whether it is possible to quantitatively correlate the intensity of acute postoperative pain felt by a patient with his facial expression. The secondary objective is to define a reliable computer algorithm that qualitatively correlates the type of acute postoperative pain experienced by a patient with his facial expression.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient undergoing surgery in our institution during the study duration,
* able to express pain intensity on NRS

Exclusion Criteria:

* patient to be operated on in the area of the face or eye
* Patient with altered facial morphology related to a dressing, suture, wound, trauma or oedema on the face
* patient not compliant or unable to clearly express pain