cyrilzakka/clinical-trials huggingface dataset:
Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms

Rationale and objectives:

Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.

The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.


Eligibility Criteria:
Inclusion Criteria:

* a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
* positive skin prick test to tree and / or grass

Exclusion Criteria:

* glaucoma
* cataracts
* acute or chronic sinusitis
* asthma
* chronic obstructive pulmonary disease
* physical nasal obstruction
* pregnant or breastfeeding
* have had a viral or bacterial infections within 2 weeks of the study commencement
* receiving allergen immunotherapy
* have used inhaled corticosteroids within 14 days prior to the study
* have used systemic corticosteroids within 30 days of the study
* travel outside of the geographic area during the 2 week study period
* use of contact lenses during the study period
* use of artificial tears during the study period
* use of eyewash irrigation during the study period
* use of lubricants during the study period
Comparison of da Vinci Simulator vs LapSim Simulator

Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy medical students aged 20 to 30 years old

Exclusion Criteria:

* No prior surgical, laparoscopic or robotic experience
* No previously known severe learning disability or mental deficiency
* No handicap limiting the usage of one or both upper limb(s)
Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe

Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.

As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva

Eligibility Criteria:
Inclusion Criteria:

* Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.

Exclusion Criteria:

* Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.

OBJECTIVES:

* Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.
* Determine the objective response and duration of response in patients treated with this regimen.
* Determine the acute side effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks.

PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)

  * Progressive or recurrent
* Bidimensionally measurable disease
* Platinum refractory disease, defined by one of the following:

  * Progression during platinum-based chemotherapy
  * Stable disease for at least 4 courses of platinum-based chemotherapy
  * Recurrence within 4 months of platinum-based chemotherapy
* No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 50 umol/L

Renal:

* BUN no greater than 8.0 mmol/L
* Creatinine no greater than 120 umol/L
* Creatinine clearance at least 60 mL/min

Other:

* Not pregnant
* Fertile patients must use effective contraception
* HIV negative
* No other prior or concurrent malignancy except basal cell carcinoma of the skin
* No active bacterial infection (e.g., urinary tract infection)
* No uncontrolled or potentially active site of infection (e.g., fistula or abscess)
* No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* At least 1 prior platinum containing regimen
* At least 50 mg/m2 per course for a maximum of 28 days for cisplatin
* At least 5 times AUC for a maximum of 4 weeks per course for carboplatin
* Prior non-taxane-containing chemotherapy allowed

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* At least 3 months since prior radiotherapy to target lesion
* Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)

Surgery:

* Prior surgical management of lymph nodes allowed
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.

Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC.
* Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below).
* Allergy to cisplatin
* Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade \> or equal to 2)
* Baseline renal insufficiency (defined as a creatinine clearance of \< than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
* Performance status 70% on the Karnofsky scale.
* Congestive heart failure with New York Heart Association functional classification \> or equal to II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
* Patient refuses to take cisplatin.
* Age \> than or equal 18
* Performance Status Karnofsky \> than or equal to 70%
* Peripheral neuropathy must be \< than grade 1
* Hematologic (minimal values)
* Absolute neutrophil count \> than or equal to 1,500/mm3
* Hemoglobin \> than or equal to 8.0 g/dl
* Platelet count \> than or equal to 100,000/mm3 Hepatic
* Total Bilirubin \< than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Patients being considered for treatment with bevacizumab must have a urine protein: creatinine (UPC) ratio \< 1.0 at screening and an MRI of brain or CT brain with IV contrast showing no evidence of brain metastases within 3 months of study entry

Exclusion Criteria:

* \> 16 weeks post-op
* Prior post-operative radiation
* \> 1 cycle of prior adjuvant chemotherapy
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
* Women who are pregnant, or breast-feeding.
Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain

Pain is very common in persons with a history of addiction, but few studies have examined the best treatment of pain in this population. This is a study to determine the pain relief provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained on stable doses of methadone or buprenorphine who have chronic musculoskeletal pain. Experimental sessions will require overnight stays on a residential research unit. In these sessions, persons will be exposed to standard experimental pain techniques at baseline and then rate the relief (if any) provided by the study medication when exposed to the same techniques. Persons will be asked to participate in 3 sessions, each separated by at least 7 days.


Eligibility Criteria:
Inclusion Criteria:

Opioid dependence according to the Mini International Neuropsychiatric Interview (MINI) and verified by the PI; urine toxicology negative for drugs of abuse but positive for opioid maintenance agent; stable buprenorphine (12-16 mg) dose for the past 30 days; chronic musculoskeletal pain (\>3 months) as documented in medical history and physical; able and willing to perform/tolerate pain procedures; able to communicate in English.

Exclusion Criteria:

Current illicit substance use at screening or during trial as verified by urine toxicology screen and/or self-report (including cannabis use); current alcohol dependence as assessed on the MINI); medical or psychiatric condition known to influence quantitative sensory testing (QST) (e.g. HIV, peripheral neuropathy, current Major Depressive Disorder, Schizophrenia, Raynaud's syndrome); use of prescribed or over the counter analgesic agents or psychotropic medications known to have analgesic properties for 24 hours prior to session; previous allergic reaction to hydromorphone or buprenorphine; women who are pregnant, lactating or planning to get pregnant during the course of the trial.
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Metastatic Nasopharyngeal Carcinoma

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Thus, we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.

Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation. With the use of intensive chemoradiotherapy, excellent treatment outcomes can be achieved for local control, but disease failure was observed in approximately 20% of patients. Moreover, approximately 10% of newly diagnosed patients diagnosed with metastasis, resulting in about 30% of NPC patients will present with either synchronous or metachronous metastasis in total.

Chemotherapy is the cornerstone of the treatment of metastatic NPC. Many studies were aimed at the systemic treatment of metastatic NPC, but most of them were retrospective studies or phase II trials with small samples. The outcome of metastatic NPC is poor with a median OS of about 20 months. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for metastatic NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge.

Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in metastatic NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum-containing chemotherapy with low-dose continuous infused 5-fluorouracil in metastatic NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).

Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal carcinoma diagnosed by pathology or cytology
* Distant metastasis confirmed by Radiographic assessments or pathology.
* Patients ever received systemic chemotherapy.

Exclusion Criteria:

* Age \<18 or \>70 years old
* Pathologic type unknown or except type I-III of World Health Organization classification
* Never underwent platinum-based chemotherapy
* Lack of information about T classification and N classification when metastasis
* Lost follow-up within one month from the start of treatment for metastasis
* Without other malignances
IMT in Hypercapnic Patients With COPD

The overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.

The development of chronic hypercapnia in patients with COPD indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. The inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration.

This study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a Power Breathe device (K3) is possible over a 6 week period in patients with COPD and chronic hypercapnia (pCO2 \> 6 kilo pascal).

IMT will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from MIP and if patients do not experience any discomfort or increased dyspnea during training.

The training of the respiratory strength is carried out daily with an electronic handheld device (Power Breathe K3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. Training will take place in the home.

Eligibility Criteria:
Inclusion Criteria:

* Have the diagnosis COPD with FEV1 / FVC \<0.70 and FEV1 \<50%
* Have elevated pCO2 in stable phase assessed by arterial blood gas with pCO2\> 6 kPa
* Have given informed consent
* Can understand written and oral instructions

Exclusion Criteria:

* Patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment
* Patients using variable oxygenation rate that may affect the carbon dioxide level.
* Unstable patients and at high risk of exacerbation during the investigation period
* Hospitalized patient with COPD exacerbation during the intervention period
* Patients with an expected need for change of COPD medication or oxygen supply equipment in the study period.

The participation in the study will be postponed if the patient is in a rehabilitation program
Intensive Motor Training After Perinatal Stroke to Enhance Walking

Early childhood injuries such as perinatal (around birth) stroke are devastating because the child lives with the problem for life, typically close to a normal lifespan. One 'opportunity' presented by a brain injury early in life compared to later in adulthood is that the young brain is much more plastic (malleable) and receptive to interventions. This is particularly true for neural circuits that are still under development. We will test the hypothesis that early (\<2 yr old), intensive leg training will improve walking more than no training or training at \>2 yr old. We will further determine the changes induced by training in motor and sensory pathways.

Children 8 mo to 3 yr old with unilateral perinatal stroke will be randomized into either: 1) Immediate Training, or 2) Delayed Training groups. The Immediate Group will train for 3 mo shortly after recruitment. The Delayed Group will go through the same measurements from the time of recruitment and at 3 mo later (with no training in between) to obtain a 3 mo change score which will serve as a control measure for the Immediate Group. The Delayed Group will also train after the 3 mo delay, when all control measures have been taken. Comparison of the improvements made by children who started training \<2 yr old with those \>2 yr old will answer the question if training at \<2 yr old is better than \>2 yr old. Finally, to determine if there are long term effects of this training, we will compare outcomes of these trained children with another group of children with the same injuries but no intensive training (i.e., too old for the training study), when all children turn 4 yr old. Clinical, kinematic and electrophysiological measures will be taken to help us understand not only the efficacy of the treatment, but also the neural mechanisms that might underlie improvements in outcome.

We are measuring outcomes at multiple times because change scores are of most interest. All children change as they age, so it is critical that we compare the change score with and without intervention.

Eligibility Criteria:
Inclusion Criteria:

* hemiplegia with confirmation of perinatal stroke through magnetic resonance imaging
* born near term (\> or equal to 36 weeks gestation)
* current age between 8 months to 3.0 years old; or currently 4 years old (control)
* no other neurological disorders
* informed consent from parent or guardian

Exclusion Criteria:

* central nervous system injury besides the one-sided stroke
* musculoskeletal problems that limit leg activity
* cognitive, behavioral or developmental impairments that preclude participation in the protocol
* unstable epileptic seizures within the last 6 months
* any contraindications to transcranial magnetic stimulation
* Botox injection in the legs over the last 6 months
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome

Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing evidence has demonstrated that these lung disorders might be an important cause of neonatal respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function, particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of SCNN1A are associated with NRDS, we conducted a case-control study to investigate the NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).


Eligibility Criteria:
Inclusion Criteria:

* Newborns with RDS

Exclusion Criteria:

* The infants were excluded if they had any congenital malformation, inherited metabolic abnormalities, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects with:

* Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
* Not having received prior systemic treatment for advanced HCC
* Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Subjects with:

* Brain metastasis or evidence of leptomeningeal disease
* History of impaired brain function (encephalopathy) or active heart disease
* Unmanageable fluid in the abdomen (ascites)
* Bleeding esophageal or gastric varices within 2 months prior to inclusion
Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada

The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Bristol-Myers Squibb GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma Patient Support Program (GEORgiA PsP) in Canada
* Have consented to the use of their de-identified data generated from information collected during the course of the GEORgiA PsP

Exclusion Criteria:

* Aged \<18 years
* HER2 positive status
* Untreated brain metastases