cyrilzakka/clinical-trials huggingface dataset:
Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer

There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer

Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer.

In all patients an accurate pre-treatment staging was performed, including: physical examination, complete blood tests and tumor markers, endoscopic ultrasonography (EUS) with fine needle aspiration biopsy, multilayer CT scan, PET-CT (positron emission computed tomography) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Jaundiced patients before or during treatment underwent endoscopic biliary stenting.

Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this neoadjuvant approach.

The induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses.

In the combined phase of the treatment all patients underwent simulation by using a Siemens 16-CT simulator (Siemens Medical System). Radiotherapy target volumes were established by CT scan and PET-CT scan.

Four weeks after the completion of radiochemotherapy, restaging, consisting of clinical examination, laboratory test, tumor markers, CT scan and PET-CT scan, was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable.

After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility Criteria:
Inclusion Criteria:

* proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
* borderline resectable or unresectable pancreatic tumours;
* age between 18 and 75 years;
* no previous radiochemotherapy to abdomen;
* 0-I ECOG (Eastern Cooperative Oncology Group) performance status;
* adequate cardiac, liver and kidney function and a good bone marrow reserve.

Exclusion Criteria:

* resectable and metastatic disease;
* previous or concomitant malignant disease;
* one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 \< 65 mmHg, Pa CO2 \> 40 mmHg, mental disability.
Yeahhh Baby! Ointment on Hip and/or Knee Pain in Men and Women

This study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index \[WOMAC\] and visual analog scale \[VAS\] for pain).

Joint pain is a common ailment among adults in the United States. In 2014, an estimated 14.6 million Americans with arthritis suffered from severe joint pain. It is therefore unsurprising that many topical ointments are currently marketed for joint pain relief including Bengay®, Icy Hot®, Jointflex®, and Aspercreme®. These ointments aim to reduce pain often through a combination of analgesic ingredients include capsaicin, salicylates, menthol, camphor, and lidocaine. Bengay® products, for instance, contain one or more of menthol, camphor, salicylates, and lidocaine. Icy Hot® products contain menthol, while some also include lidocaine.

Yeahhh Baby! ointment is an herbal (botanical: plant-based) treatment for those impacted by joint pain. The product contains a variety of herbal ingredients that have been touted by some within the alternative medicine community as "healing agents." The product started selling in 2016 and is available commercially as an all-natural alternative to other commercially available products. This ointment consists primarily of coconut oil (98%), with magnesium and small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing.

The present study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index \[WOMAC\] and visual analog scale \[VAS\] for pain).

Eligibility Criteria:
Inclusion Criteria:

* Self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days
* Recreationally active (2 or more days per week)
* Not obese (BMI \< 30kg/m2)

Exclusion Criteria:

* Tobacco users/Smokers
* Allergic to coconut, walnuts, oak, olives
* Currently using anti-inflammatory medicines or dietary supplements (and not willing to cease for one-month prior to participation and throughout study)
Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne

This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.

Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.

* For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
* For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.

Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years and older.
* Subject in good health.
* Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.

Exclusion Criteria:

* Presence of \>2 nodular lesions in the areas to be treated.
* Presence of any cysts in the areas to be treated.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
* History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
* History of keloid scar formation.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Presence of a metal stent or implant in the facial area to be treated.
Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery

This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery

Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has different leading causes, including myocardial injury, inadequate myocardial protection, the effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and magnesium sulfate are used for the management of POAF.

Statin is used commonly for its lipid lowering action, however, some studies shows that statin has powerful pleiotropic effects including its antiarrhythmic effect.

This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus magnesium sulfate after cardiac replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing isolated valvular replacement surgery.
* Preoperative rhythm: Sinus rhythm.
* Preoperative troponin I \< 0.01 ng/mL.
* Normal lipid profile.
* White blood cells (4-11 X 103/mm3).
* Preoperative C-reactive protein \< 3 mg/L.

Exclusion Criteria:

* History of atrial fibrillation.
* Any degree of heart block or patients with implanted pacemaker.
* Prior use of Antiarrhythmic drugs.
* Preoperative lipid lowering therapy (e.g statins) during the last 3 months.
* Previous treatment with any type of magnesium containing supplementation (the week before the intervention).
* Underlying heart failure or Left ventricular ejection fraction \< 0.3.
* Previous myocardial infarction.
* Diabetes or other metabolic disorders.
* Renal diseases.
* Hepatic dysfunction.
* Underlying thyroid problems (hypo/hyperthyroidism).
* Underlying inflammatory disease (active or controlled)
* Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions.
* Psychological disorders,
* Emergency cardiac surgery
Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCI from at least one-year post injury;
* Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment
* Age \> 18 years;
* Indication to spinal cord stimulation surgery for chronic pain;
* Be unable to stand or step independently;
* No current anti-spasticity medication regimen;
* No botox injections in the prior 3 months;
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
* Willingness and ability to comply with scheduled visits and other trial procedures.

Exclusion Criteria:

* Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated (i.e. metal clips, claustrophobia);
* Pregnancy or breastfeeding;
* Any significant psychiatric disease;
* Use of illicit drugs;
* Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping;
* Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
SpareBrain - Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage

Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.

In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.

Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.

In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.

Eligibility Criteria:
Inclusion Criteria:

* aneurysmal subarachnoid haemorrhage

Exclusion Criteria:

* age under 18 years
* pregnant
* moribund patient
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

The purpose of this study is to compare the results of foam treatment of varicose veins (foam sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Proven truncal venous incompetence (of \>1 second duration) on venous duplex scanning. (Great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory thigh vein (AATV) or other major tributary).
* Agreed preference for foam sclerotherapy treatment.
* Signed consent form agreeing to be part of the trial.

Exclusion Criteria:

* Total deep venous reflux.
* Known allergy to liquid sclerosant.
* Pregnancy or breast feeding.
* Arterial disease.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease, in pre-dialysis or dialysis
* Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria:

* Anemia due to non-renal causes
* Pregnant or lactating women
* Uncontrolled hypertension
* Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005

The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.


Eligibility Criteria:
Inclusion Criteria:

* 1. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.
* 2. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
* 3. Subject is judged to be in good general health as determined by the investigator.
* 4. Demonstrate satisfactory technique in the use of pMDI.

Exclusion Criteria:

* 1. Subjects who prematurely discontinued from the study SKY2028-3-005.
* 2. Life-threatening asthma within the past year.
* 3. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
* 4. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
* 5. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
* 6. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
* 7. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past 1 week.
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence

As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be male or female
* Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
* The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic.

Exclusion Criteria:

* Pregnant and breast feeding females will be excluded.
* Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded.
* Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.
A Pilot Randomized Controlled Trial of Chatbot Use in Older Adults for Lifestyle Change

The purpose of this study is to evaluate the acceptability and preliminary effectiveness of a smartphone-delivered AI-based chatbot in promoting healthy dietary behavior and physical activity participation among older adults.

The purpose of this study is to evaluate the preliminary effectiveness of a smartphone-delivered AI-based chatbot in promoting healthy dietary behavior and physical activity participation among older adults. It is a preliminary study with two arms.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 or above.
* are community-dwelling.
* are proficient in Mandarin.
* have an Internet connection.
* have at least one instant messaging app on the smartphone or agree to download one.

Exclusion Criteria:

* have any neurocognitive disorders.
* are unable to engage in moderate-intensity level of physical activity due to a preexisting medical condition.
* live with another participant who will participate in this study.
Virtual Integrated Environment in Decreasing Phantom Limb Pain

The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees.

Nearly all traumatic limb amputees will experience cognizance of a phantom limb and perceive a vivid impression that their lost limb is not only fully present, but also painful. The John Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a highly flexible and adaptable virtual reality system that allows patients to observe movement of a 3D virtual arm. Using the VIE, recorded signals from the residual limb will be correlated to the desired motion of the phantom limb. We hope to correlate the consistency of these patterns with PLP to determine if increased control of the phantom limb leads to decreased PLP.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 to 65 years of age, active duty military, beneficiary, or retiree.
* Written informed consent and written authorization for use or release of health and research study information.
* At least one upper-limb amputation (trans radial or trans humeral) at any time prior to enrollment.
* No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
* Normal neurological examination with the exception of limb amputation.
* Ability to follow study instructions and likely to complete all required visits.
* Experiencing PLP at least 3 times a week at an intensity of at least 3 out of 10 at the time of enrollment.

Exclusion Criteria:

* Presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the traumatic brain injury (TBI) program at Walter Reed National Military Medical Center (WRNMMC) and noted in the patient's medical record.
* Known uncontrolled systemic disease
* Participation (either concurrently or in the 30 days prior to enrollment) in another study for treatment of PLP
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound study results, or interfere significantly with the subject's participation in the study.
* Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study
* Subjects with lack of effort as determined by the neurologist or psychiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) in order to exclude those with blatant exaggeration or malingering. Subjects who score lower than 42/50 on the TOMM-2 will not continue in the study