cyrilzakka/clinical-trials huggingface dataset:
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Karnofsky performance status of at least 50
* No contraindications to MRI scanning with intravenous contrast.
* MRI scan consistent with brain metastasis as per radiology report.
* Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
* Patients must have an extra-cranial primary tumor diagnosis.
* Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
* Additional lesions will each be treated with stereotactic radiosurgery.
* Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

Exclusion Criteria:

* Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
* Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
* More than four additional diagnosed brain metastases.
* Contraindication to general anesthesia.
* Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
* Primary brain tumor.
* Contraindication to MRI scans or intravenous contrast.
* Pregnant and breast-feeding females.
Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors.

OBJECTIVES:

* Determine the safety and efficacy of thalidomide in patients with metastatic low-grade neuroendocrine tumors.

OUTLINE: Patients receive oral thalidomide once daily on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed low-grade neuroendocrine tumors

  * Carcinoid tumors
  * Islet cell tumors
* Metastatic disease
* Progression of disease within past 4 weeks by radiological evidence
* At least 1 bidimensionally measurable lesion by CT scan or MRI

  * Bone metastasis not considered measurable if only site of disease
* No active brain metastases

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin normal
* AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 50 mL/min

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study
* No grade 2 or greater neuropathy
* No other clinical circumstances that would preclude study
* No other prior malignancy except:
* Non-melanoma skin cancer
* Other cancer that has been curatively treated, has had no evidence of recurrence within the past 5 years, and is at low risk for recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior thalidomide
* No concurrent interferon

Chemotherapy:

* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior major surgery

Other:

* No more than 1 prior systemic therapy regimen
* At least 4 weeks since prior systemic therapy regimen
* No other concurrent therapeutic agent
Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry

Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose of this registry is to connect people with DM or FSHD with researchers studying these diseases. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases. The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.

The National Registry of DM and FSHD Patients and Family Members was developed to create a link between patients and scientists in order to promote research on these rare illnesses. The Registry is sponsored by the National Institutes of Health.

Patients that are interested in joining the Registry can email or call to request an application or download the forms from the website (www.dystrophyregistry.org). The Application packet contains:

* A Patient Information Form, which asks about your muscle strength, general health, and how your disease affects your daily life
* A Medical Records Release Form, which allows us to contact your doctor and obtain records about your diagnosis
* An informed Consent Form, which describes the study's purpose and what you can expect while you are involved with the project.

After you are enrolled in the Registry, there are several ways to participate in research. The activities include:

* Complete an annual update form to help us keep track of how your symptoms change over time.
* Receive updates about the progress of the Registry, research highlights, and other news related to muscular dystrophy through newsletters, an email listserv, and Facebook.
* Receive letters from the Registry when researchers are looking for patients to take part in studies. These projects may include filling out questionnaires, exploring new treatments, and other types of research.

There is no obligation to participate in these activities. Taking part in any study or filling out the annual updates are completely up to you.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with DM, FSHD, or related diseases or are an unaffected family member of someone diagnosed with one of these diseases
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy

This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for participation before the completion of MT-3995-J05 Study
* Completion of MT-3995-J05 study

Exclusion Criteria:

* UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study
* Symptomatic and clinically significant hypotension
* QT prolongation or torsades de pointes
* New York Heart Association (NYHA) Class III or IV heart failure
* Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study
Expiratory Muscle Strength Training for Hypernasal Speech in Children

When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

The objective of this study is to examine the feasibility and efficacy of expiratory muscle strength training to improve velopharyngeal closure in patients with velopharyngeal dysfunction and nasal air emissions. A randomized, controlled trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will be block randomized based on Pittsburgh Weighted Speech Scale (PWSS) score (5-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

Eligibility Criteria:
Inclusion Criteria:

* Pittsburgh weighted speech scores of 5 or greater
* Ages 5-17 years

Exclusion Criteria:

* CAPS-A-AM hypernasality score \<2
* Previous speech surgery (e.g. palatoplasty or pharyngeal flap)
* Speech surgery scheduled within the next 56 days
* Unable or unwilling to perform the tests and exercises outlined in the study
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
* Written informed consent

Exclusion Criteria:

* Legal age limitations (country specific)
* Indication for anticoagulation other than PE or DVT
* Creatinine clearance (CLcr) \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
* Life expectancy \<3 months
* Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 months
* Active bleeding or high risk for bleeding
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \> 110 mm Hg
* Pregnancy, or childbearing potential without proper contraceptive measures, women who are breastfeeding.
Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.

The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.

The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have just begun orthodontic treatment after bracket cementation.
* Be willing and have signed the informed consent.
* Presence of cemented metal brackets throughout the upper and lower arches.
* Presence of good oral health: dental, periodontal and soft tissue

Exclusion Criteria:

* Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.
* Pregnant, since they are not claimants of fixed multibrackets appliances.
* Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.
* Under 11 years old.
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury


Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
Gastric Emptying of High Calorie Liquid Meals

Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Anesthesiologists' concern about aspiration and the increasing awareness towards the negative impact of prolonged restriction of oral intake have shaped the current fasting guidelines. However, due to the perceived safety of prolonged fasting and practical considerations, adoption of the fasting guidelines is suboptimal.

Gastric ultrasound is a quick, non-invasive method to evaluate gastric contents and aspiration risk. Gastric ultrasound can accurately discriminate between solid particles and fluid content, and mathematical models can reliably predict the volume of the gastric contents from the gastric antral area (GAA).

This project aims to use gastric ultrasound to provide new data that can support management strategies in perioperative patients, that ensure both a low aspiration risk and an adequate nutritional support.

The investigators will test the hypothesis that commercially available liquid meals can be safely used preoperatively. A pilot crossover, study on healthy volunteers will be conducted to determine the gastric emptying time of high-calorie drinks, as compared to clear fluid.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and 2

Exclusion Criteria:

* Allergy or intolerance to any of the study products or the ingredients
* Previous esophageal, gastric, or duodeno-pancreatic surgery
* Gastric banding or large hiatal hernia
* mmobility
* Contraindication to right lateral positioning
* Gastrointestinal diseases and disturbances
* Participation in another, possibly interfering study
* Diabetes mellitus
* Pregnancy
Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients

Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.


Eligibility Criteria:
Inclusion Criteria:

* More than 60 Kg of weigh
* Patients with directed treatment with colistin as the recommended antimicrobial treatment protocols in the hospital to treat some of the following serious infections caused by carbapenems resistant A. baumannii: (i) bacteremia; (ii) nosocomial pneumonia or (iii) infection of skin and soft tissue (cellulitis, abscesses or infected ulcers).
* Written informed consent form.

Exclusion Criteria:

* Refractory shock or other illness with an expectative of life ˂ 48 hours after the recruitment;
* Patient declared not to resuscitation maneuvers;
* Suspicion or demonstration of endocarditis, osteomyelitis, or meningitis;
* Known hypersensitivity to polymyxins;
* Pregnancy.
Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter

Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Between 19 and 80 years old
2. Persons requiring urethral catheterization for more than 2 weeks after surgery \* due to urological diseases

   \* Radical cystectomy
3. Subjects who voluntarily decided to participate and signed the written informed consent
4. A person who can understand and follow the instructions and participate in the pre-clinical period.

Exclusion Criteria:

1. A person with a congenital abnormality in the urinary or reproductive system
2. Immunodeficiency disease (eg HIV infected)
3. Urinary tract fistula
4. Allergic history of the material used in the catheter
5. Symptomatic UTI by baseline time point
6. Dermatitis at the catheter insertion site
7. Pregnant or lactating women
8. A person who does not agree to contraceptive \* in a medically accepted manner until the end of the study and 4 weeks after the end of the study.

   Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc.
9. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
10. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
Carotid Plaque Imaging in Acute Stroke

The purpose of this study is to determine the frequency, characteristics, and consequences of vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the territory of the internal carotid artery.

Even with extensive diagnostic workup the underlying etiology remains unidentified in about 25% of patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). Non-invasive high-resolution magnetic resonance imaging (HR-MRI) of the carotid artery allows detecting vulnerable plaques (VP) and quantifying single plaque components. The hypotheses behind this study are that i) a substantial proportion of cases of AIS and TIA within the anterior circulation and no identified cause (cryptogenic AIS or TIA) are caused by VP in the carotid artery; ii) that these patients are at a high risk of developing a recurrent stroke, TIA, or clinically silent lesions detectable by brain MRI; and iii) that VP in the carotid artery are associated with specific infarct patterns as detected by diffusion-weighted MR imaging. Finally, the investigators will search for biomarkers associated with vulnerable carotid artery plaques. Motivating this study are the following considerations: i) data on the frequency and characteristics of VP in patients with cryptogenic AIS or TIA will provide valuable insights into stroke mechanisms; ii) depending on the results this study may have implications for diagnostic decision making and provide the basis for the planning of targeted interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 49 years old
* Acute ischemic stroke or transient ischemic attack (TIA)
* Neurological symptoms compatible with a stroke or TIA in the anterior circulation (territory of the internal carotid artery)
* Onset of symptoms within the last 7 days
* 1 or more acute ischemic lesion(s) visible on MR diffusion-weighted imaging (DWI) in the territory of a single internal carotid artery
* Presence of carotid artery plaques in the ipsilateral or contralateral carotid artery as defined by ultrasound (criteria: plaque thickness at least 2mm; located within 1cm proximal or distal to the carotid bifurcation)
* Written informed consent

Exclusion Criteria:

* Primary referral to an outside hospital (to avoid recruitment bias)
* DWI positive lesions outside the territory of a single internal carotid artery
* Carotid artery stenosis \> 69% (North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria) ipsilateral to the stroke or TIA as defined by ultrasound (systolic peak flow velocity ≥ 300 cm/s)
* Standard contra-indications for MRI
* Documented allergy to MRI contrast media
* History of radiation to the neck area
* Renal clearance \< 30 ml/minute
* Creatinine levels \> 2 times the upper limit of the standard range of the respective laboratory within the last 30 days prior to MRI
* Surgical procedure within 24 hours preceding the MRI
The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms

The goal of this study is to determine if a developed protocol involving modulated auditory stimulation is better than non-modulated auditory stimulation in reducing anxiety and depression in human subjects.

A protocol has been developed that provides patients an intervention of listening to specifically designed filtered and modulated music that stimulates the part of the nervous system that induces a calm physiological (bodily) state. This enhancement may help re-establish nerve pathways between auditory processing and emotional regulation systems which promotes improved emotional regulation in regards to depression and anxiety. For this study, participants will either be assigned to the active group who receives the therapy with auditory stimulation that is modulated, or be assigned to the control group who will receive the same interventions without the modulated auditory stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Client of DayBridge
* 18 years old or older
* Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder

Exclusion Criteria:

* Previous participation in the SSP
* Self-reported hearing loss