cyrilzakka/clinical-trials huggingface dataset:
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-79 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Expected survival ≥ 6 months.
* Histologically or cytologically confirmed pancreas adenocarcinoma.
* Resectable or borderline resectable pancreatic cancer.
* Adequate organ performance based on laboratory blood tests.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* Ability to understand and the willingness to receive a needle biopsy.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had any chemotherapy or radiotherapy prior to entering the study.
* Patients with metastasis disease.
* Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
* Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
* Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia.
* Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
* Known active hepatitis B or C infection.
* History of immunodeficiency (including HIV infection) or organ transplantation.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Exoskeletal Support in Stroke

This interventional study will measure motor performance, including 3D movement analysis and muscle activity, in response to exoskeleton assistance. The cohort design will compare stroke patients to healthy controls. Data collection will be conducted in a single, 2-hour session. Investigators will also access stroke patients' brain MRIs that were obtained as standard of care during acute admission for stroke.


Eligibility Criteria:
Inclusion Criteria:

Healthy controls:

* Having obtained the age of 18 years
* Neurologically healthy (i.e., no history of: traumatic brain injury, peripheral neuropathy, seizures, etc.)
* Strongly right-handed according to at least 80% score on the Edinburgh Handedness Inventory (Oldfield, 1971; Veale, 2013). The use of right-handed participants is a common feature in this field of study. This is due to the slight differences in arm control between left- and right-handed individuals (Sainburg \& Kalakanis, 2000).
* Ability to give informed consent

Survivors of stroke:

* Having obtained the age of 18 years
* have a diagnosis of stroke more than six months prior to entry into the study;
* have the ability to reach, unsupported, to approximately 70% of arm length
* ability to give informed consent

Exclusion Criteria:

All participants

* have any conditions that limit their capability of using a Head Mounted Display (HMD) for a VR environment or cooperate with the protocol.
* have any orthopedic injuries to the upper extremities.
* Have neurological injuries other than stroke.
* Have excessive pain in any joint of either arm that could limit the ability to cooperate with the protocols.
* Visuospatial neglect
* Apraxia
* Global inattention
* Legal blindness
Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.

Contactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical algorithm, generates vital sign readings. This technology has been refined and embedded in a smartphone app designed to acquire heart rate, respiratory rate and oxygen saturation using a front-facing smartphone camera.

Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital sign monitor readings are promising; however, less than 5% of the population studied in the app development phase had oxygen saturation levels below 95% making it impossible to ensure reliability in these populations.

The goal of this study is to compare readings acquired using this rPPG app with the readings from hospital grade, Health Canada approved vital signs monitors used in healthcare settings with a focus on subject with low oxygen saturations. We will also study other sociodemographic and clinical features that may influence the accuracy of the readings. This will be achieved by recruiting consenting adults presenting to care in acute care settings and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and conventional hospital vital sign monitors simultaneously. Readings will be repeated within 2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings and determine the accuracy and precision of the rPPG app readings.

It is expected that the vital sign readings acquired with the rPPG app will be almost identical to those acquired using hospital-grade monitors for all subjects regardless of age, gender, skin colour, COVID status and relevant comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Persons willing to participate and capable of providing informed consent, age of 18 years of more.
* Person able to sit still for the duration of the reading (maximum 2 minutes per reading).
* Persons with freckles, discreet skin pigmentation changes

Exclusion Criteria:

* Unable to provide informed consent
* Persons who are unable to follow basic instructions due to altered mental status, delirium, dementia or other conditions.
* Age \< 18
* Intubated patients and patients requiring masks for supplemental oxygen
* Persons refusing to remove masks, eyewear, or clothing obstructing the face for the duration of readings.
* Persons with facial tattoos, large birthmarks or other skin alterations (scars, hemangiomas) on their nose or upper cheeks (cheekbones).
Change and Clinical Significance of Plantar Fascia Thickness After ESWT

The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT) on the thickness of plantar fascia measured by ultrasonographic examination among patients with chronic plantar fascitis. The change of plantar fascia thickness will be correlated with clinical improvement.

The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT) on the thickness of plantar fascia measured by ultrasonographic examination among patients with chronic plantar fascitis. Two different dosage of ESWT will be applied, and the outcome will be followed 3 and 6 months after the treatment. The change of plantar fascia thickness will be correlated with clinical improvement, including the pain improvement, foot function, and quality of life at follow up.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as plantar fasciitis for at least 6 months
* refractory to other conservative treatments

Exclusion Criteria:

* Acute infection of soft tissue/bone
* Malignancy
* Epiphysiolysis in the focus
* Blood coagulation disorders
* Pregnancy
* Patients with pacemaker
* Foot deformity
* Autoimmune disorders-related arthropahy
* Sciatica
* Previous treatment with ESWT
Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache

It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.

Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population.

There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
* Individuals between the ages of 18-65,

Exclusion Criteria:

* History of trauma or surgery to the head and neck region,
* Presence of lesions or metal implants in the application area,
* Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion,
* Pregnancy or suspicion,
* Other primary and secondary headache types,
* Individuals who received physiotherapy in the last 6 months,
The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder

Despite the psychosocial difficulties common among young adults with autism spectrum disorders(ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial(RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention known as PEERS for Young Adults with high-functioning young adults with ASD using self- and caregiver-report measures.

1. Both the case and the control of this study shall be a high-functioning group consisting of young adults aged 18 to 35 years with ASD and an IQ of 70 or over. A total of 48 young adults will be recruited and divided into two groups. One will be the case group and the other will be the waitlist control group. And the study will be going on 3 institutions. Again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and young adult. That is, the program will be carried out two times in each of both groups. The waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting.
2. Effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. Equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and four months after the completion of the program.

Eligibility Criteria:
Inclusion Criteria:

* 18\~35 years of age with ASD and IQ of 70 or over

Exclusion Criteria:

* Young adults who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities
* Young adults who are uncooperative in the treatment, lack motives and are hard to participate voluntarily
* Young adults who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion and have psychotic symptoms
The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis

In this double-blind, randomized, follow-up study investigators evaluated and compared the effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis. 30 patients were treated with Tiszasüly hot mud-pack (Group 1), 30 patients with Kolop hot mud-pack (Group 2) for 10 working days. Knee pain, function a nd qualitiy of life were measured at baseline, at the end of treatment and 3 months later.

The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis.

Methods: In this double-blind, randomized, follow-up study 60 patients with knee osteoarthritis were treated with either Tiszasüly hot mud-pack (Group 1), or with Kolop hot mud-pack (Group 2) on 10 occasions for 2 weeks (10 working days). 100 mm Visual Analogue Scale (VAS) for knee pain, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lequesne Index for physical function and EuroQoL-5D for quality-of-life measure were recorded at baseline, at the end of treatment (Week 2) and 3 months later (Week 12).

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age with knee osteoarthritis (radiologically Kellgren-Laurence II-III. stage)
* resting VAS pain is \> 50 mm

Exclusion Criteria:

* infection
* fever
* tumour
* neurologic disorders with numbness and tingling sensation in the lower extremeties
* skin disease aroud the knee
* untreated hypertension
* heart failure (NYHA II-IV. stage)
* inflammatory rheumatic diseases
* knee arthroplasty
* steroid or hialuronic acid injection into the knee joint within 3 months
* physiotherapy of the knee within 3 months
* inflammatory knee osteoarthitis
Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography

Laryngospasm and post-extubation stridor are major postoperative airway difficulties in pediatric patients using tracheal tubes. These conditions are frequently caused by epithelium edema and anesthesia-related problems. Because it could reveal tracheal and laryngeal issues, ultrasound is an essential method for establishing the proper endotracheal tube size and minimizing difficulties. This research focuses on the use of ultrasonography to predict and understand pediatric postoperative airway complications.

In pediatric patients with tracheal tubes, laryngospasm, and post-extubation stridor are the two worst-case postoperative airway complications. Post-extubation stridor is caused by cricoid ring epithelial swelling, whereas laryngospasm is an uncommon but potentially fatal condition that occurs during the induction and recovery of anesthesia. When determining the proper endotracheal tube (ETT) size and minimizing postoperative problems, ultrasonography (USG) is important since it considers factors other than ETT size and irritation, like placement, surgical manipulation, and patient-specific circumstances. By displaying laryngeal and tracheal edema and the size and location of the ETT, ultrasound helps identify, at least in part, children who may experience respiratory issues. Thus, this research aims to illustrate how ultrasound could be utilized to predict the development of postoperative airway complications and to investigate the conditions that cause them in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 1-11 years
* Anesthesia risk class: 1-2
* Patients who have given written consent

Exclusion Criteria:

* Patients aged under 1 or over 11 years
* Patients undergoing emergency surgery
* Patients with skin integrity issues such as open wounds, infections, or skin lesions in the area to be examined
* Patients with laryngeal or tracheal deformities
* Patients suspected of having a difficult airway
* Patients who have previously undergone surgery on the upper airway, larynx, or trachea
* Patients with a history of reactive airway disease (asthma, bronchial hyperreactivity)
* Patients who have had an upper respiratory tract infection within the last two weeks
* Patients with an anesthesia risk class of 3 or higher
* Patients undergoing high-risk surgery
Effects of Virtual Reality Versus Motor Imagery in Children With Cerebral Palsy

Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.

Eligibility Criteria:
Inclusion Criteria:

Children of 7-12 years of both genders, Children with Mini Mental Scale score \>24.

Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.

Exclusion Criteria: History of any Visual and Hearing Impairments, Virtual game phobia.

History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.
Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects

The purpose of this study is to compare the effects of individualized brain stimulation based on simulation and conventional brain stimulation in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

• Healthy adult men and women without history of central nervous system disease and abnormalities

Exclusion Criteria:

* Under 18 years old, 75 years old or older
* A person who has inserted a metal object in a skull
* A person with complete occlusion of the carotid artery
* A person with epilepsy
* Pregnant and lactating women
* Who is not eligible for the test
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Primary outcome variable is healing at the final follow up visit.

The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.

Eligibility Criteria:
Inclusion Criteria:

* Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
* Likely cryptoglandular origin
* Must be at least 18 years of age
* Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
* Patients willing and able to submit to postoperative follow-up evaluations

Exclusion Criteria:

* Crohn's Disease
* Evidence of on-going local infection
* History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
* Superficial fistulas without any muscle involvement
* Fistulae of traumatic origin, including obstetric
* Intersphincteric fistulas that would be candidate for fistulotomy
* Horseshoe or multi-tract fistulas
* Ano-vaginal or recto-vaginal fistulas
* Anastomotic fistulas (ileo-anal, colo-anal)
* A wound-healing or autoimmune disorder (including insulin-dependent diabetics)
* Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy
* Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate
* History of prior or current pelvic radiation
* Difficulty comprehending or complying with the study (in surgeon's opinion)
Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Meet ACR criteria for diagnosis of active RA and have at \>6 swollen joints and \>9 tender joints
* Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX
* Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit
* Age 18 years and older

Exclusion Criteria:

* Prior treatment with any TNF antagonist, including adalimumab
* History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
* Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
* Chest X-ray with calcified granuloma and/or pleural scarring
* Positive TB skin test, RT23 dose skin test, \>5 mm at 48 to 72 hours
* Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
* Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
* Female who is pregnant or breast-feeding.