cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
* Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
* Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
* Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
* Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.

Key Exclusion Criteria:

* Pregnant or nursing women,
* Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
* Patients for whom the use of secukinumab or ustekinumab is contraindicated.
* Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
* Evidence of ongoing infectious or malignant process
* Subjects receiving high potency opioid analgesics
* Ongoing use of prohibited psoriasis treatments/medications

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors.

Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib.

CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1.

The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old on the day of consent
2. Capable of understanding and complying with the protocol requirements and signed informed consent
3. Documented histological or cytological diagnosis of HCC
4. HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1

Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
2. Prior TKI treatment
Duration of Music Interventions and Pain Tolerance (DOMINANT)

This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 64 years of age
* Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
* Provision of written informed consent by subject

Exclusion Criteria:

* Significant hearing impairment
* Current complaints of tinnitus
* Current use of analgesic medication
* Presence of acute or chronic pain
* History of cardiac disease or arrhythmias
* Current treatment by a medical specialist or general practitioner
* Professional musician or singer (practicing in average \>1 hour each day)
* Pregnancy
Automatic Evaluation of the Extent of Intestinal Metaplasia With Artificial Intelligence

Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, the high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.

Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Gastric intestinal metaplasia (GIM) is an intermediate precancerous gastric lesion in the gastric cancer cascade. Studies have shown that the 5-year cumulative incidence of gastric cancer in IM patients ranges from 5.3% to 9.8% . With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, The high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-80 years who undergo the IEE examination

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* patients with previous surgical procedures on the stomach
* patients who refuse to sign the informed consent form
Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex

To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. In this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG) signal in facial nerve monitoring during parotid surgery. The aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Eligibility Criteria:
Inclusion Criteria:

* undergoing parotid surgery

Exclusion Criteria:

* facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults

This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female (not of childbearing potential), 18 to 65 years of age, inclusive, at screening.
* The subject voluntarily consents to participate in this study and
* provides written informed consent before the start of any study-specific procedures.
* The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
* Female subjects must be of non-childbearing potential (defined as surgically sterile \[i.e., had a bilateral tubal ligation, hysterectomy, or
* bilateral oophorectomy at least 6 months before the dose of study drug\] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening).
* Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or agree to use a condom with spermicide when sexually active with a female partner. Male subjects must also agree to refrain from sperm donation for 90 days after study drug administration.
* The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, at screening and weighs 50 to 100 kg (110-220 pounds), inclusive, at screening and Check-in.
* The subject is considered to be in stable health by the investigator

Exclusion Criteria

* Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
* Any recent viral or bacterial infection.
* Participated in any clinical study in last 6 weeks.
* History of significant drug allergy
* History of significant vision, ocular or retinal disorder.
* Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations

Other protocol-defined inclusion/exclusion criteria could apply.
A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy

The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) patients

Cerebral palsy (CP) may lead to various motor deficits, which further influence the activities and participation. It would be ideal to characterize neural network and motor control model in patients with CP that underlies their clinical behavior by identifying altered neural network and motor control associated with behavioral improvement. The aim of this study is to investigate the brain image and motor control in patients with CP evaluated by multimodal imaging studies utilizing multi-modal techniques and kinematic analysis.

This study includes a prospective longitudinal study of patients with CP over one-year. This study will be executed in 3 phases within 3 years: 1st phase (1st years): to establish the multimodal brain images and motor control, and clinical outcomes protocol with a prospective one-year follow-up study in healthy subjects; 2nd phase (2nd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in older patients with CP; and 3rd phase (3rd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in younger patients with CP. In a prospective longitudinal study, each participant received 3-times measurements: at the beginning, 6 months later, and one year after the first data collection point

Eligibility Criteria:
Inclusion Criteria:

* (1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants

Exclusion Criteria:

* (1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection
The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort

Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath.

Methods: This study is a randomized clinical trial. It adopts a two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. The measurement tools used self-made structured questionnaires, the Richards-Campbell Sleep Questionnaire （RCSQ）, Numerical Rating of Comfort （NRC）, and heartbeat and blood pressure monitors. Data analysis included descriptive statistics, Chi-square and Fisher's exact correction tests, unpaired t tests and repeated measures ANOVA inferential statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been using a ventilator for 21 days or more
* Individuals aged 45 years or older
* Clear consciousness and the ability to compare hands or hold a pen, with proficiency in Mandarin or Taiwanese communication
* Willingness to participate in the study after receiving an explanation of the research purpose

Exclusion Criteria:

* Individuals with severe mental illness
* Those with cognitive impairments
* Severe visual or hearing impairments
* History of lower limb venous thrombosis
* Amputation or inflammation in the lower limbs
* Muscle contractures in the lower limbs
* Peripheral neuropathy
* Allergic history related to essential oils
Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF

Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.

When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.

In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).


Eligibility Criteria:
Inclusion Criteria:

* Patients (\>=18 und \< 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
* At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
* Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR \> 2..
* Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
* Atrial tachycardia occurring during ablation of CFAE (defined as CL \> 200 msec und stable activation sequence).

Exclusion Criteria:

-
Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial

Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal surgery may reduce nasal obstruction severity.

Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with unilateral cleft lip and palate and dentofacial deformity (age \>16 for females, \>18 for males; 40 in experimental and 40 in control groups) Interventions: In the experimental group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all patients will receive Le Fort I osteotomy only.

Measurements: All patients will undergo history taking, clinical examination, radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and 24 months after surgery.

Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a p value of less than 0.05.

Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty, effectiveness


Eligibility Criteria:
Inclusion Criteria:

1. Taiwanese adults with dentofacial deformities (DFD)
2. Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
3. Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013

Exclusion Criteria:

1. Previous OGS or nasal surgery
2. Patients with nasal polyposis, rhinosinusitis or neoplasia
3. Patients with clefts or craniofacial anomaly
4. Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
5. Noncompliance for test
6. Noncompliance to test schedule
7. Won't sign informed consent
Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.

It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).

The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.

If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.

The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.

Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.


Eligibility Criteria:
Inclusion Criteria:

* planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
* suitable for home enteral nutrition

Exclusion Criteria:

* inability to provide written informed consent
LEGION™ Revision Metal Hypersensitivity Study

This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).

A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.

Eligibility Criteria:
Inclusion Criteria:

* Subject is skeletally mature
* Subject is willing to sign and date an IRB/EC approved consent form
* Subject is a candidate for a revision knee replacement
* Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
* Subject agrees to adhere to the 10-year study visit schedule

Exclusion Criteria:

* Subject with a known metal hypersensitivity
* Subject requires a known bilateral revision TKA
* Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation
* Subject has active infection or sepsis (treated or untreated)
* Subject with an immunosuppressive disorder
* Subject has presence of malignant tumor, metastatic, or neoplastic disease
* Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* Subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
* Subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint Female subject is of child-bearing age and unwilling to use an approved method of contraception
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study
* Subject is severely overweight (BMI\>40)
* Subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
* Subject is facing current or impending incarceration