cyrilzakka/clinical-trials huggingface dataset:
Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Background. Brain metastases (BM) are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). In contrast to microsurgical resection, Gamma Knife radiosurgery (GKRS) is a non-invasive neurosurgical method, which allows treatment in multimorbid patients with contraindications for surgery in general anesthesia. Furthermore, stereotactic radiosurgery is the only local treatment method for multiple disseminated and thereby non-resectable brain metastases. In general, microsurgical resection is considered the treatment of choice for BM exceeding \>3 cm in diameter. However, since the establishment of the dose-staged technique, larger metastases can also be treated radiosurgically in selected patients. This novel method allows the application of high cumulative dose for the treatment of complex brain metastases.

Aim. The aim of the study is to evaluate the clinical outcome in brain metastases patients with tumor volume between 8 and 20 ccm3. The clinical outcome will be compared between surgically and radiosurgically treated BM patients.

Patients and methods. The investigators plan to conduct an explorative prospective study including about 50 radiosurgically and 50 surgically treated patients with brain metastases. If a patient fulfill study-relevant inclusion criteria at the time of BM diagnosis, the principle study investigator will offer both treatment options to the patient. Depending on patient's choice, he/she will be categorized either to surgical or to radiosurgical treatment group. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks since both treatments represent suitable therapy options.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years and under 90 years
* Patients with KPS ≥70
* Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor
* Maximum of three brain metastases on the diagnostic MRI
* Tumor volume of 8-20 ccm3 on the diagnostic MRI
* Lobular brain metastases
* Patients without any contraindications for both treatment options
* Written, signed informed consent for study particaption after study explanation

Exclusion Criteria:

* Patients under 18 years and over 90 years
* Patients with KPS \<70
* Patients with other primary tumor
* More than three brain metastases on the diagnostic MRI
* Tumor volume \<8 or \>20 ccm3 on the diagnostic MRI
* Patients with contraindications for both treatment options
Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.

OBJECTIVES:

* To assess cyclo-oxygenase-2 (COX-2) activity in patients with early-stage non-small cell lung cancer (NSCLC) and correlate the results with serum vascular endothelial growth factor (VEGF) levels, tumor microvessel density score, tumor prostaglandin E2 (PGE_2) and matrix metalloproteinases (MMP) levels, and the major urinary metabolite of PGE_2, PGE-M.
* To assess the effect of specific COX-2 inhibitors (celecoxib) on COX-2 expression within the primary tumor, serum VEGF levels and tumor microvascular density, tumor PGE_2 and MMP levels, and urinary PGE-M in a cohort of patients with early-stage NSCLC.

OUTLINE: Patients receive oral celecoxib 400 mg twice a day for 5 days in the absence of disease progression or unaccepted toxicity. Patients with early-stage disease then undergo surgery.

Biopsy, serum, and urine samples are obtained at baseline and after celecoxib treatment. The biopsy specimen are examined for the expression of cyclo-oxygenase-2 (COX-2), PGE_2, and selected MMPs by immunohistochemistry, western blotting, and northern blotting. Serum and urine samples are analyzed for VEGF and PGE-M expression. COX-2 tumor expression is correlated with serum VEGF levels; tumor MMP-2, MMP-9, and PGE_2 expression; urinary PGE-M and microvessel density scores.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Presumed histological or cytological diagnosis of non-small cell lung cancer

  * Diagnosis to be confirmed upon study entry to collect biopsy material for correlative studies
* Stage I-IIIA disease

PATIENT CHARACTERISTICS:

* ECOG performance status of 0-2
* Serum creatinine ≤ 1.5 mg/dL
* Granulocytes ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3
* AST ≤ 3 times normal
* Bilirubin ≤ 1.5 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active unresolved infection

PRIOR CONCURRENT THERAPY:

* At least 7 days since prior and no concurrent non-steroidal anti-inflammatory agents or other cyclo-oxygenase-2 inhibitors
* At least 7 days since prior parenteral antibiotics
* No prior systemic chemotherapy or radiotherapy
Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

Summary from initial protocol

Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study

Study design: prospective, multicenter, observational, non-comparative study

Study population: 240 consecutive cases (HA-coated implants), 60 cases per study site

Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaires HOOS and EQ-5D

Type and extent of the risks associated with the study participation as well as benefits for the patient:

All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
* Patient shall be provided with a HA-coated SL-PLUS™ stem
* Patient has no general medical contraindications regarding the surgery
* Signed informed consent form for the participation in the study
* X-ray examinations are possible
* Patient is willing to participate in the post-operative follow-up program
* Age: 18-75 years

Exclusion Criteria:

* Previous failed hip joint surgery (endoprosthesis) of the side affected
* Previous infections in the joint affected; systemic infections
Clinical of Hypersensitivity Reduction Efficacy on Two Toothpastes

To evaluate the clinical efficacy of a Dual Zinc Toothpast containing 5% small particle size silica (AC43) as compared to Colgate MaxFresh Tea Toothpaste on dentin hypersensitivity reduction after brushing two times daily (morning and evening) for a period of 8 weeks


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 18-70, inclusive.
* Availability for the eight-week duration of the study.
* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50 gms. of force.
* Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for three months prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Sensitive teeth with a mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
* Current participation in any other clinical study.
* Pregnant or lactating subjects.
* Allergies to oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.
Type of Exercise and Education in Patients With SubAcromial Pain Syndrome

Patients seeking care for shoulder pain will be recruited to enroll will be randomized to one of four combined treatment groups; eccentric or traditional strengthening alone and eccentric or traditional strengthening with pain neuroscience education. Patients will be followed for 1 year.

Patients seeking care for their shoulder in a primary care setting will be recruited to participate in a trial investigating the value of different exercise and education regimens. Patients that choose to participate will be randomized to 1 of 4 different treatment groups focused on strengthening of the rotator cuff and shoulder girdle muscles: eccentric strengthening alone; traditional strengthening alone; eccentric strengthening plus education focused on pain neuroscience, traditional strengthening plus education focused on pain neuroscience. All patients will be seen in the clinic for 4-6 sessions over a 4-week period, as well receive a home exercise program that aligns with the exercise group there were randomized to.

One-year outcomes will be compared across all 4 groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65
2. Read and speak English well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys
3. TRICARE beneficiary (eligible for medical benefits in the Military Health System)
4. Primary complaint of new episode of unilateral shoulder pain; defined as not having sought care for shoulder condition in 6 months prior
5. Meets criteria for SAPS, as determined upon physical exam
6. At least 20% on either pain or disability subscales of the SPADI outcome measure
7. Available and willing to come in for treatment up to 8 sessions over a 4-week period

Exclusion Criteria:

1. History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery, or shoulder injury as the result of trauma (e.g. fall, MVA)
2. Presence of cervical radiculopathy, radiculitis, or referral from cervical spine (reproduces shoulder symptoms)
3. Patient reports their condition is "acceptable" on Patient Acceptable Symptom State (PASS) at baseline
4. Anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
5. Unable to give informed consent to participate in the study.
Understanding Fitness' Function in Determining Activity

The purpose of the study is to determine how measuring strength (by squeezing a tool called a hand grip dynamometer) and cardiorespiratory fitness (by climbing stairs) and sharing the results with subjects impacts exercise.

The Understanding Fitness Function in Determining Activity (UFFDA) Study was initiated at the 2014 and 2015 Minnesota State Fair to determine if measuring muscular strength and CRF would motivate individuals to increase their physical activity. Eligible individuals consented to participate and were randomized in a 1:1 allocation to control or intervention groups. All participants provided their current Exercise Vital Sign (EVS calculated by multiplying the number of moderate-vigorous exercise sessions/week by the average minutes/session). The intervention group had VO2max estimated using a timed previously validated Step Test and muscular strength measured using a Hand Dynamometer. Results with age appropriate normative data for both grip strength and a "good or superior" VO2max were provided to the intervention group. Our hypothesis was participants who receive the intervention would increase physical activity (measured by EVS) compared to control participants.

Eligibility Criteria:
Inclusion Criteria:

Greater then 18 years old and able to complete the 20-step test to estimate CRF.

Exclusion Criteria:

History of heart disease, Syncope, Chest pain, Dyspnea, Use of beta blockers, Use of non-dihydropyridine calcium channel blockers, Evidence of any unstable medical conditions. Pregnant
Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures
* Male or female patients aged 18 years or older
* Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
* Females must be post menopausal or surgically sterile
* Taking aspirin as an anti-platelet medication

Exclusion Criteria:

* Use of any thienopyridine or ticagrelor within 7 days prior to randomization
* Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
* Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
* History of intolerance or allergy to aspirin
Monitoring the IMmUological TOXicity of Drugs

Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the immunological system and are responsible of a wide range of rare immunological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 02/01/2018
* Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)

This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.

The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant disease
* Scheduled to receive a single dose of one or more of moderately emetogenic chemotherapeutic agents during Cycle 1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or Karnofsky score ≥60
* Predicted life span ≥4 months
* Laboratory values demonstrating adequate hematologic status
* Premenopausal females must not be pregnant or lactating and must agree to use effective birth control

Exclusion Criteria:

* Received chemotherapy within 6 months prior to starting on study drugs
* Scheduled to receive subsequent treatment due to a refractory response to first or second line chemotherapy
* Received an investigational drug within 30 days prior to starting on study drugs
* Radiation therapy to the abdomen or pelvis in the week prior to starting on study drugs
* Vomiting in the 24 hours prior to starting on study drugs
* Active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
* Known hypersensitivity to Aprepitant (EMEND®), Dexamethasone or 5-HT3 receptor antagonists
* Presentation with gastrointestinal obstruction symptoms
* Symptomatic primary or metastatic central nervous system malignancy
Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation

The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects. The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record. These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated only at periods T0 and T3.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
2. Have availability to attend FO / UFPel days predetermined;
3. Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.

Exclusion Criteria:

1. Patients younger than 40 years;
2. Patients who are not users of denture upper and lower;
3. Patients denture wearers during periods of less than five years.
Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.


Eligibility Criteria:
Inclusion Criteria:

* 2-year history of seasonal allergic rhinitis
* Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
* Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Women of childbearing potential who are not using an acceptable form of birth control
* Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
* Use of any chronic medication which could affect the course of seasonal allergic rhinitis
* Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
* Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
* Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
* Has rhinitis medicamentosa
* Investigational drug use within the previous 30 days
* Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
* Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
* History of multiple drug allergies, allergy to antihistamines or corticoids
* History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study