cyrilzakka/clinical-trials huggingface dataset:
Neonatal Pain Management and Pain Monitoring Using New Methods

The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure.

The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.


Eligibility Criteria:
Inclusion Criteria:

* Gestational Age (GA) at birth 32+0 - 42+0
* Admitted to NICU
* Parents are able to read, write and speak Finnish

Exclusion Criteria:

* With a postnatal age of 14 days or more
* Apgar points were 6 or less at 5 minutes of age
* Has been found grade III or IV cerebral haemorrhage
* Major congenital anomalies
* Has intubated or receiving a nCPAP
* Has received analgesics or sedatives for less than 24 hours prior to the study
Study on the Incidence of Malignant Neoplasms in Patients with Parkinson's Disease and Heterozygous Mutation of the GBA Gene

This multicenter retrospective observational study investigates the incidence of malignant neoplasms in Parkinson's disease (PD) patients carrying heterozygous pathogenic variants in the GBA1 gene. The study compares these patients to individuals with idiopathic PD and to the general population within a large national cohort.

The rationale for the study lies in the growing evidence indicating an increased risk of malignant neoplasms in patients affected by Gaucher disease.

The primary objective is to assess whether PD patients with GBA1 mutations have a higher incidence of malignant neoplasms compared to the general population. Secondary objectives include comparing the incidence of malignant neoplasms between GBA1-PD and idiopathic PD patients, as well as between idiopathic PD patients and the general population. Additionally, the study aims to characterize oncological conditions by sex, age, center, and tumor site, with specific attention to distinguishing hematologic tumors from solid tumors.

By identifying potential associations between GBA1 mutations and malignancies in PD, the findings could guide more comprehensive patient management, including screening for malignant neoplasms alongside Parkinson's disease care.

The study will involve a network composed by different Italian Movement Disorders Centres and the corresponding local cancer registries, responsible for the active collection of cancer cases. Data will be collected from approximately 3000 consecutive Parkinson's disease (PD) patients, including about 500 patients carrying GBA1 mutations and 2500 idiopathic PD. Data about the presence of malignancies will be extracted from the Local Cancer Registries for each patient.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Diagnosis of Parkinson's Disease through the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's Disease.

Exclusion Criteria:

* Uncertain diagnosis
Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle

The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context.

To investigate whether oxytocin (24IU) might interact with female sex hormone in modulating the rewarding effect of compliment to women in a romantic context.

The study employs a double-blind, within-subject, placebo-control design. Women will be administered with the same drug twice (oxytocin or placebo) respectively the fertile and luteal phase followed by a MRI scanning. During fMRI participants will rate men's attraction based on their facial pictures of average attractiveness associated with compliments of different combination of form and topic. Each male face will be paired with two sentences of the same kind. After the fMRI participants will recall the judgment followed by a memory test during which they have to indicate whether the they have seen the face during scanning (old) or whether it is an unknown face (new).

Eligibility Criteria:
Inclusion Criteria:

* Single in the past 3 months
* Healthy subjects with regular menstrual cycle

Exclusion Criteria:

* Pregnant, menstruating, taking oral contraceptives
* metal implanted, with tatoo, or hair dyed within 6 months
* participated in another intranasal experiment within 6 months
* with a history of past or current psychiatric or neurological disorder
Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

Eligibility Criteria:
Inclusion Criteria:

* Curatively resected, histologically confirmed colon adenocarcinoma
* AJCC/UICC high-risk stage II, stage III colon cancer
* Age over 18 years old
* Performance status (ECOG scale): 0-1
* Adequate major organ functions
* Patients should sign a written informed consent before study entry

Exclusion Criteria:

* Colon cancer other than adenocarcinoma
* Rectal cancer
* R1 or R2 resections
* Other malignancies within the last 5 years
* Symptomatic peripheral sensory neuropathy
* Presence of other serious disease
* Lactating or pregnant women
* Fertile women
WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.

There will be one group of study participants.

The group will (independently of this research study) have weight loss surgery to help them with weight loss.

All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided.

The group will have an MRI Brain Scan at each time-point to study the changes in the structure and function of the brain tissue.

Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Eligibility Criteria:
Inclusion Criteria:

* Between age: 20-75 yrs, English speaking, Physically mobile
* Body Mass Index (BMI) \>35 kg before surgery
* Compatible of MRI Scanning
* Willing to give a small blood sample
* Capable of providing informed consent

Exclusion Criteria:

* Prior or current neurological disorder
* Major psychiatric disturbance
* Unstable medical conditions (cancer)
* MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
Project My Heart Your Heart: Pacemaker Reuse

Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy ≥ 2 years.
* Indications for device implantation must be fulfilled per standard of care. Consistent with 2008 American College of Cardiology / American Heart Association guidelines for device therapy, one of the following class I indications must be met.
* Sinus Node Dysfunction
* Acquired Atrioventricular (AV) Block
* Chronic Bifascicular Block
* Hypersensitive Carotid Syndrome
* Lack of financial ability to pay for a new device must be assessed and documented.
* All other methods of new device acquisition must be exhausted.
* Patient must be agreeable and able to follow-up with the implanting center within 2 weeks for wound check, at 2 months, 6 months, and every 6 months thereafter for routine pacemaker checks.

Exclusion Criteria:

* Severe valvular disease
* Severe pulmonary disease
* End-stage renal disease (creatinine clearance \< 30 mL/min) whether or not on dialysis
* Evidence of ongoing systemic infection
* Prior pacemaker or implantable cardioverter-defibrillator implantation
* Significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications).
* Presence of any other condition that the local investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period
* Pregnant women
Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.

With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.

Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.

In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.

The primary aim of the study is

1. To understand the epidemiology and prognostic factors for proximal humerus fractures

   * Incidence
   * Health service utilization
   * clinical and functional outcomes
2. To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.

We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective


Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years old and above
2. Radiologically confirmed proximal humerus fracture
3. Within 3 weeks of their injury

Exclusion Criteria:

1. Open fracture
2. Mentally incompetent patients
3. Co-morbidities precluding anaesthesia
4. Severe soft tissue compromise
5. Neurovascular compromise
6. Pathological fracture other than osteoporosis
7. Surgery delayed \> 3 weeks
8. Pregnancy
Diabetes Education and Care for Deaf Populations

This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".


Eligibility Criteria:
Inclusion Criteria:

* Identify as Deaf/Hard of Hearing
* living with diabetes (any type)
* speak and understand English or American Sign Language
* have access to internet
* willing to participate in the intervention

Exclusion Criteria:

* participating in another diabetes study
* have significant cognitive impairment
* are pregnant or planning to become pregnant in the next year
* have life expectancy of \<6 months
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years

This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.

Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can increase levels of pain, need for painkillers, and even length of stay in hospital.

Caring for children must take in account their anxiety. This anxiety can be treated through drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very poorly assessed.

Parents will be given a consent form as well as an information note. This study aims to compare the level of post operative anxiety (D1)of children having hypnosis before receiving anaesthetics to the level of anxiety of children getting the usual care.

All the children included in this study will have a pre operative consultation with the Pain Management Nurse.

The study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be included in this study (60 in each arm) The primary outcome measure is the level of anxiety at day 1 (24 hours after surgery) Other outcome measure are

* the difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
* the use of morphine during the first 24 hours This study is a prospective randomized trial, comparing a usual analgesics procedure to an experimental analgesics procedure including hypnosis before anaesthesia.

Expected impact of this study :change in procedures, decrease of anxiety levels in patients by the use of hypnosis before anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* age 10-18 years
* Orthopaedics surgery (spinal column, osteotomy)
* ASA 1 \& 2

Exclusion Criteria:

* casualty surgery
* patient or family unable to understand the study (language, disability ...)
* patient or family refusing the study
Using Gait Robotics to Improve Symptoms of Parkinson's Disease

This study evaluates the benefits of exoskeleton-based exercise for improving mood and cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention), non-exoskeleton exercise (active comparator), and wait-list control (no treatment).

Parkinson's Disease (PD) is a movement disorder that significantly impairs mobility and increases risk of falls. Many people with PD also experience mild cognitive impairment (MCI) and some progress to Parkinson's disease dementia (PDD). Non-pharmacologic treatments such as physical activity and exercise are known to be neuroprotective and may improve cognition, mood and overall functioning in PD, but such interventions can be challenging for individuals with PD and cognitive impairment to fully participate in. Robotic over-ground exoskeletons have the potential to overcome this barrier; however there are no scientific data yet to support the use robotic exoskeletons in the PD population or those with mood disorder and/or declining cognitive function.

This therapeutic exploratory trial will fill this gap in knowledge and provide critical data for understanding how to integrate exoskeletons into clinical practice for age-related movement disorders when cognitive decline is present. Specifically we will test if an 8-week functional exercise program (gait, balance, aerobic exercise) using the KEEOGO Rehab(tm) exoskeleton can improve mood and cognition, as well as gait and balance, compared to the same functional exercise without using the exoskeleton, and a wait-list control (no treatment).

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Cognitive function score \>=16 on Montreal Cognitive Assessment (MoCA)
* Diagnosed with Parkinson's disease, Hoehn and Yahr stage 1 to 4
* Able to walk 10 meters without stopping and without human assistance (using assistive devices such as cane or walker if normally used)
* Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the KEEOGO device

Exclusion Criteria:

* Legally blind
* Treatment with another investigational drug or other intervention within the study period
* New medications started within last 4 weeks
* Skin condition that contraindicates use of orthotics or support braces
* Lower-extremity amputation above or below the knee
* Uncontrolled orthostatic hypotension
* Psychiatric disorders such as schizophrenia or bipolar disorder
* Other diagnosis that impairs gait and balance, such as, but not limited to, chronic obstructive pulmonary disease; peripheral arterial disease; vestibular disorders; cerebellar disease; cerebral palsy; muscular dystrophy; spinal cord injury; stroke or other brain injury; severe degenerative joint disease (osteoarthritis, rheumatoid arthritis, etc.)
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven diagnosis of malignant GIST that was not amenable to standard therapy.
* Failed prior treatment with imatinib mesylate, defined either by progression of disease (according to Response Evaluation Criterion in Solid Tumors (RECIST) or World Health Organization (WHO) criteria), or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. Intolerance to prior imatinib mesylate therapy was defined as follows:
* Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient (such as nausea) that persisted despite standard countermeasures
* Evidence of unidimensionally measurable disease.

Exclusion Criteria:

* Previous treatment on a SU011248 clinical trial.
* Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately treated with no evidence of recurrent disease for 12 months.
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
* Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females.
* Hypertension that could not be controlled by medications (\>150/100 mm/Hg despite optimal medical therapy).
Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI

The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.

The study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. Preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.

Eligibility Criteria:
Inclusion Criteria:

* TIMI 0/1 flow after successful artery obstruction stenting
* Men and women aged 40 years and older

Exclusion Criteria:

* Coronary artery dissection
* Abrupt intraoperative coronary artery closure
* Intraoperative thrombosis
The Relationship of Serum Uric Acid With Severity of Knee Osteoarthritis

Osteoarthritis (OA) is the most prevalent form of arthritis. Its pathogenesis remains poorly understood. Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis (Krasnokutsky et al., 2017). The hallmark of OA is the degradation and loss of articular cartilage, although most tissues of the joint become affected, such as bone, synovium, ligaments, menisci (knee), labrum (hip), periarticular fat, and muscle (Englund, 2023).It is believed that there is a pathological link between hyperuricemia and OA Therefore, we conducted a cross-sectional study to evaluate an association between elevated SUA and radiographic OA of the knee) Bipan Shrestha, 2019 (.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (Age\>18 years) with a complaint of knee pain.

Exclusion Criteria:

* 1.Any patient with a history of trauma to the knee. 2 Any patient with knee complaints as a part of autoimmune connective tissue disease.