cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema

The objective of this study is to evaluate the safety and tolerability of a single Subcutaneous (SC) dose of Ecallantide in children and adolescents with Hereditary Angioedema (HAE).

This pilot study is an open-label, non-randomized, single-arm study to evaluate the tolerability and safety of a single SC administration of ecallantide in up to approximately 10 pediatric subjects with HAE during an initial acute attack. The study is planned to enroll subjects 2 through 15 years of age who present with an acute cutaneous, abdominal, or laryngeal HAE attack. No more than 3 study sites will be included until a goal of 10 patients is achieved.

After treatment for an initial attack, one additional open label treatment with ecallantide will be offered to subjects contingent upon having been treated previously and presenting with a subsequent acute cutaneous, abdominal, or laryngeal attack of HAE at least 7 days after initial treatment. Open-label treatment for a second HAE attack will continue until 10 patients have been treated for an initial attack. Safety evaluations will be performed at each subsequent ecallantide-treated attack as for the initial treated attack

Eligibility Criteria:
Inclusion Criteria:

1. 2 through 15 years of age, inclusive (ie, from the second birthday through the day prior to the sixteenth birthday) at the time of the subject's first attack.
2. Documented diagnosis of HAE type I or II. Diagnosis must be confirmed by a documented immunogenic (below the lower limit of normal) and/or functional (\< 50% of normal levels) C1- Inhibitor deficiency. Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening.
3. Informed consent (and subject assent as appropriate) signed by the subject's parent(s) or legal guardian(s).

Exclusion Criteria:

1. History of an adverse reaction (AE) to Ecallantide in the past
2. Diagnosis of angioedema other than HAE
3. Participation in another clinical study during the 30 days prior to treatment
4. Any known factor/disease that might interfere with the treatment compliance, study conduct, or result interpretation
5. Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
6. Treatment with angiotensin converting enzyme (ACE) inhibitors within 7 days prior to treatment.
7. Use of hormonal contraception within the 90 days prior to treatment for females of childbearing potential
8. The subject is pregnant or breastfeeding
Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.

This study will investigate the absorption, distribution, metabolism and excretion (ADME) of 14C PF-06651600 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-06651600 in humans.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead ECG, and clinical laboratory tests.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
* Infection with hepatitis B or hepatitis C viruses.
* Participants with selected acute or chronic infections or infection history.
* Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin.
* History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
* Use of tobacco/nicotine containing products within 3 months prior to dosing or positive urine cotinine test.
Endodontic Regenerative Procedure for Immature Non-vital Teeth

In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation.

Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.

All participants will be prospectively assigned to the REP treatment group. Results from the treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman School of Dental Medicine.

All materials used in this protocol are FDA approved and commercially available for similar applications. This study does not seek a new use or application of any materials, instead recommendations of the American Association of Endodontists (AAE) will be followed to evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA apexification.

The overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs.

Other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.

Eligibility Criteria:
Inclusion Criteria:

Subjects followed prospectively

* 7-18 years old
* salvageable permanent non-vital tooth with immature apex whether anterior or posterior
* receiving dental care at the Henry M. Goldman School of Dentistry Historical controls
* 7-18 year old
* salvageable permanent non-vital tooth with immature apex whether anterior or posterior
* received care and has accessible records at the Henry M. Goldman School of Dentistry
* had either the Calcium hydroxide apexification or MTA apexification between 2007 and 2017

Exclusion Criteria:

* allergic to medications necessary to complete procedure
* health status not in: a) ASA-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes
* history of dental trauma within 6 months due to possibility of internal and external root resorption.
* if tooth pulp space is needed for post/core final restoration
* pregnancy in female subjects
Serial Night Time Position Splint on Systemic Sclerosis

This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during the study. Patients will be evaluated at baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time position splint who will be adjusted monthly, while the control group will remain the drug treatment. The outcomes assessed will be: pain, hand range of motion, quality of life, functional capacity, upper limb function and dexterity. Our hypothesis is that the serial night time position splint will improve the hand range of motion in diffuse systemic sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Diffuse Systemic scleroses diagnosed following the ACR criteria
* Older than 18 years old
* Sclerodactyly

Exclusion Criteria:

* Neurological, psychiatric diseases and other rheumatic disease (including overlapping)
* Previous use of splints or allergy to splint material
* Surgery schedule to the next 12 months
Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain

Injections of local anesthetics (freezing) and steroids are often performed around injured nerves in individuals with nerve injury-related pain. The current standard of medical care is to inject a combination of local anesthetics and steroids around injured nerves, but there is no proof that this is better than injecting only local anesthetic, or even just sterile salt water. There is evidence to believe that injection of local anesthetic (without the steroid) can calm the injured nerve, and provide pain relief from a few days up to a few months. Injection of sterile salt water also has the potential to provide pain relief by breaking scar tissue around the nerve, thereby relieving compression. The aim of this study is to compare pain relief and possible adverse effects from these three different treatments for foot and ankle nerve pain relief.

All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up at 1 month after the last injection, and a phone follow-up 3 months after the last injection.

This is a small-scale study, and information obtained from this study will help in planning and conduct of a larger study with more participants. The larger study will help determine the best possible option for injection in patients with nerve-related injury pain.


Eligibility Criteria:
Inclusion Criteria:

1. Pain in foot in neuro-anatomically congruent location following trauma (including surgery) for more than three months
2. Physician-reported DN4 scoring confirming neuropathic pain (score \> 3/10)
3. Average intensity of pain more than 3/10 on numerical rating score
4. Failed trial of appropriate doses of first line medications for neuropathic pain (anticonvulsants and/or antidepressants) for six weeks

Exclusion Criteria:

1. Age \< 18 or age ≥ 80 years
2. Perineural or intra-articular steroid injections in the last 6 months
3. Allergy to local anesthetics and/or steroids
4. Ongoing litigation issues related to the patient's pain
5. Pregnancy
6. Coagulopathy or systemic infection
7. Peripheral neuropathy or myopathy, central neuropathic pain (e.g. post-stroke pain)
8. Infection in the ankle or foot
9. An unstable medical or psychiatric condition
10. Significant catastrophizing as indicated by pain catastrophizing scale (PCS) score equal to or more than 30/52
Recovery After Laparoscopic Surgery

During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.

The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there may still be a blockade of up to 70% of the receptors.

This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged hospitalization.

This study will describe changes in balance and subjective muscle weakness after laparoscopic surgery.

The primary hypothesis is that sway area is increased 30 min after extubation compared to the preoperative value.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Same-day gynaecological laparoscopic surgery
* Informed consent

Exclusion Criteria:

* Body mass index above 30 kg/m2
* Insufficient renal function
* Liver insufficience
* Neuromuscular monitoring not possible
* Known allergy towards medicine used in the protocol
* Daily use of opioids
* Known disease which can interfere with the balance
* Pregnant/lactating
* Cannot read or understand danish
* Fast-track intubation with use of succinylcholine
Post Marketing Surveillance Study for ONIVYDE® in South Korea

The purpose of this study is to characterize the safety of ONIVYDE when used under standard clinical practice in South Korea; and to describe effectiveness in patients receiving ONIVYDE in combination with 5-fluorouracil (5-FU) and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in South Korea.


Eligibility Criteria:
Inclusion Criteria:

Patients who are prescribed ONIVYDE per investigator's judgment shall be included if:

* Patient / legally authorized representative/ family member gave written informed consent
* Patient is indicated for treatment according to ONIVYDE South Korea prescribing information
* Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
* Documented metastatic disease
* Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy
* Adequate hepatic, renal and hematological function

Exclusion Criteria:

* Patients enrolled in Servier sponsored ONIVYDE Registry or any other Servier sponsored ONIVYDE study
* Patients who have experienced severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL
* Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation of interstitial lung disease. Patients with confirmed diagnosis of interstitial lung disease
DCB Angioplasty for Coronary Lesions: an OCT Analysis

In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.

The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the use of a durable polymer or metal scaffold. The DCB has been proven to be effective with paclitaxel in preclinical trials and in clinical practice for the treatment of coronary lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence tomography (OCT) is an intravascular imaging modality that has higher resolution than intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images allows accurate measurement of lumen and lesion. However, only a few studies have investigated the effect of DCB on the intimal lumen in the acute phase and during the follow-up using optical coherence tomography (OCT). In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization.

Demographic, angiographic, and procedural data were collected. Participants were followed up with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze qualitative analysis of changes in plaque characterization, and late lumen loss. The participants were followed up for long-term clinical events (including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization).

Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography shows that at least one coronary artery has a diameter stenosis \>70% (left main stem diameter stenosis\>50%)
* Stable or unstable angina
* Availability for follow-up for up to 12 months

Exclusion Criteria:

* Acute myocardial infarction within 48 hours
* Severe calcified lesions
* Unable to tolerate dual antiplatelet treatment (DAPT)
* Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L
* Active bleeding or bleeding tendency
* Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
* Life expectancy \< 12 months
* Pregnancy or planning pregnancy
* Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
* Participation or planning to participate in another clinical trial during the same period
* Refusal to comply with the study protocol
A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH

Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of progressive and severe right ventricular failure. Target drugs are reported to be associated with significant improvement of clinical outcome for PAH patients. However, previous studies using those target drugs focused on the change of 6-minute walk distance (6MWD) and or hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical worsening, TTCW), benefits from target drugs for PAH patients are not clear. We previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH patients who were unresponsive to target drugs. Hence, we design the randomized study to identify the effect of PADN on PAH.

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of PADN on PAH patients. Based on the previous studies, the rate of pulmonary arterial hypertension (PAH)-related event was around 30% after 6-month treatment using target drugs. And our previous data showed that this PAH-related event at 6-month after PADN procedure was 15%. As a result, a total of 270 PAH patients was required, with 135 patients/per group at a ratio of 1:1 randomization. All patients underwent an 18F-DOPA PET/CT scan of pulmonary arteries and the heart, performed at basement.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures;
* Men and women 18 years and older;
* Group I PAH, defined as a mPAP≥25mmHg, PCWP\<15mmHg and PVR\[The PVR =(mPAP-PCWP)/CO\]\>3.0 Woods unit.

Exclusion Criteria:

General exclusion criteria:

* Pregnancy and breast feeding mother;
* Estimated life expectancy \<12 months;
* Scheduled major surgery in the next 6 months;
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
* Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.

Procedural exclusion criteria:

* WHO group II, III, IV, V PH
* Severe Renal dysfunction (Ccr\<30 ml/min)
* Blood platelet count\<100,000/L
* Expected life span\<6-month
* Systematical inflammation
* Malignant cancer(s)
* Tricuspid valve stenosis, Supra-pulmonary valve stenosis
* Allergic to studied drugs or metal materials.
Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.

The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.


Eligibility Criteria:
Inclusion Criteria:

* Male or female more than 18 years old

Exclusion Criteria:

* Age less than 18 years old
* Pregnant women
* Local carcinoma excluding radiotherapic or surgical control
* Poor general condition
* Contraindication to general anesthesia
* Uncontrolled diabetes
Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers

The purpose of this study is to evaluate the impact of arts-based programming on health, well-being, and resilience. Patients who have cancer or are the caregivers of someone with cancer are being asked to take part in this study.

Objective:

Primary:

To assess the feasibility and acceptability of arts-based programming for community-dwelling cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:

1. Recruitment
2. Participation
3. Retention (drop-outs)
4. Satisfaction

Secondary:

To assess the participants' ability to:

1. Define goals and strategies using the contents of the program.
2. Implement the strategies in their daily activities in the short-term.
3. Continue to use these strategies after the program ends.

Exploratory:

To perform exploratory analyses on the impact of arts-based programming on health, resilience, and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Able to participate in all program sessions
* Cognitively able to consent to participate
* Speaks, reads, and writes English
* Diagnosis of cancer or caregiver of someone with cancer

Exclusion Criteria:

* Severe visual or auditory impairment
* Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program
The Impact of Chewing Food on Stroke Patients

The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

The study will last 15 days for each participant. The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Short-course Antimicrobial Therapy in Sepsis

The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received antibiotics for presumed infection

Exclusion Criteria:

* Prolonged therapy (eg, endocarditis)
* Severe immunosuppression
* Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
* Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.