cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Fractionated Stereotactic Radiation Therapy

There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. We thus propose a phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration.
* Patients with measurable brain metastases who have a gadolinium contrast enhanced MRI obtained within 30 days prior to registration. Patients with CT based diagnostic imaging without MRI will not be allowed to enroll on this trial.
* No surgical resection of the target lesion, defined as ≥3 cm but ≤6 cm in size on MRI of the Brain with contrast
* Prior Whole Brain Radiation Therapy (WBRT) is allowed
* Age ≥ 18 years
* Karnofsky performance status ≥ 60 or ECOG ≤2
* Women of childbearing potential and male participants must practice adequate contraception
* History/Physical examination within 30 days prior to registration
* Life expectancy\>3 months
* Patients are allowed to enroll if previously treated to other lesions with SRS
* Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints.

Exclusion Criteria:

* Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid examination (CSF)
* Plan for chemotherapy or targeted agents during treatment. All hormonal therapy and bone supportive therapy may be continued while patient is on study.
* Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed.
* Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
* Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity.
* Previous treatment of the target lesions with radiotherapy.
Hematologic Profile, Vit. B12 and Folic Acid in Cirrhotics Received Sofosbuvir and Daclatasvir With or Without Ribavirin

Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied.

Hepatitis C virus (HCV) infection is a global health problem that affects 170 million people worldwide, and approximately 55% (95 million) of the infected population is in South East Asia and Western Pacific countries.

Hepatitis C virus (HCV) is considered one of the main causes of chronic hepatitis and also may be complicated by serious complications as liver cirrhosis, ascites and hepatocellular carcinoma. It is also, one of the leading indications for liver transplantation (LT) in adults around the world.

Abnormalities in hematological parameters are common in patients with cirrhosis. The pathogenesis of abnormal hematological indices (HIs) in cirrhosis is multifactorial and includes portal hypertension-induced sequestration, alterations in bone marrow stimulating factors, viral- and toxin-induced bone marrow suppression and consumption or loss. Abnormalities in HIs are associated with an increased risk of complications including bleeding and infection.

So, early recognition and early treatment of those patients with chronic HCV infection can modify its natural history. There are many factors affecting the outcome of HCV infection as viral, environmental and host factors, including immunologic and genetic susceptibilities.

Till 2011, the main lines of therapy were Interferon plus ribavirin for at least 48 weeks but these combinations was associated with low incidence of Sustained Virological Response (SVR). Now, there is era of Direct Acting Analogues that used for treatment of patients with chronic HCV infection and associated with high rate of SVR.

Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily.

Eligibility Criteria:
Inclusion Criteria:

* Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin

Exclusion Criteria:

* Chronic hepatitis due causes other than chronic HCV infection
* Coinfection with HIV or HBV infection
* Hepatocellular carcinoma
* Decompensated cirrhosis
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses.

The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing


Eligibility Criteria:
Inclusion criteria

* Healthy male according to the assessment of the Investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (incl.)
* Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
* Further exclusion criteria apply
Vibratory Anesthesia in Trigger Finger Injections

This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during trigger finger injections. This will be done by randomizing patients who are diagnosed with trigger finger, warrant and choose to continue with a steroid injection into each of the respective anesthetic (or lack thereof) methods described. After conducting this and gathering data on the subjects pain felt, we will compare the analgesia from each of the anesthetic methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult
* Diagnosed with trigger finger
* Warrants a trigger finger injection

Exclusion Criteria:

* Subjects with known decreased light touch sensation in the territory of the trigger finger injection.
* Not diagnosed with trigger finger or does not warrant a trigger finger injection per the typical treatment algorithm adopted by the attending physician.
Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease

The main objective of the work is to evaluate, in the French health care system, the performance of early ultrasound screening for severe heart disease between 11 and 14SA in high-risk populations.

Numerous studies have shown a link between increased nuchal translucency and heart disease. Although high-risk fetal populations are identified between 11 and 13 SA on clinical and biological criteria and by screening ultrasound (Echo T1), cardiac morphology analysis is routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22 SA (EchoMorpho-T2) inducing a difficult wait for the couple.

The development of increasingly efficient ultrasound probes has made it possible to explore the foetal heart at an earlier stage. International learned societies recommend an early morphological examination with heart-centered slices before 14 weeks in high-risk situations. This practice is not systematic in France and no study has evaluated its feasibility and impact in a French care network.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women whose fetus is at high risk for congenital heart disease:

* Nuchal translucency measurement on T1 echo ≥3.5mm
* Cardiac or extra-cardiac morphological abnormality suspected on the T1 screening echo
* First degree family history for the fetus (patient, spouse, 1st children of the couple) of significant congenital cardiopathy (excluding AIC, muscular VIC or persistent CA).

Exclusion Criteria:

* Multiple Pregnancies
* non-emancipated minors, persons unable to express their consent.
* Lack of affiliation to a social security scheme.
* Subject in a period of exclusion from another study,
* Subject under administrative or judicial supervision
* Subject cannot be contacted in case of emergency
Preoperative Mindfulness In Musculoskeletal Tumor

Psychosocial distress is common in patients with an oncologic diagnosis, with anxiety being present in almost 20-30% of the patients.\[1, 2, 10\] Mindfulness exercises have shown to reduce this distress.\[4, 5\]

Recently, the implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity patients.\[9\] However, its lasting effect after the single intervention was not evaluated. Nonetheless, because the intervention is not time consuming and is easy to implement it may benefit orthopaedic oncology patients in their pre-operative coping.

The implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity participants. In this research study, the investigators are studying a 60-second interactive personalized acceptance-based mindfulness exercise

The aim of this study is to evaluate the effect of a preoperative 60-second interactive personalized acceptance-based mindfulness exercise (intervention) versus a brief educational pamphlet (control) on anxiety in patients undergoing curative surgery for a musculoskeletal malignancy.

Eligibility Criteria:
Inclusion Criteria:

* All adult (\>18 years) patients attending the Orthopaedic Oncology Department outpatient clinic (Dr. Santiago Lozano-Calderon, Dr. Kevin Raskin, Dr. J. Schwab) at the MGH with a histologically confirmed musculoskeletal malignancy undergoing curative surgery will be enrolled at their last preoperative visit.

  * Patients with a musculoskeletal malignancy undergoing curative surgical treatment
  * Histologic confirmation of malignancy prior to curative surgery
  * Primary surgery of musculoskeletal malignancy at the Massachusetts General Hospital
  * Able to give informed consent
  * English fluency and literacy

    --- English fluency is needed because the intervention (a 60-seconds video) is in English and there is no alternate version available.
  * Age ≥18 years

Exclusion criteria:

* Significant axis I or II psychopathology that would interfere with participation in the study
* Pregnant patients
* Metastasis at presentation
The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound

Musculoskeletal ultrasound( MSUS) is highly operator-dependent and proper training is needed to ensure appropriate use and minimize risk of incorrect image interpretation.To acquire skills in MSUS, it is mandatory to assure training in both the cognitive ability to recognize normal and pathological findings within the images and the psychomotor component of the examination. This study will examine the effect of a novel developed e-learning platform "The Ultrasound LearNing plAtform (ULNA)", on pre- and post-course musculoskeletal ultrasound performance of rheumatology residents. Moreover, to examine the resident's satisfaction with the e-learning platform ULNA.


Eligibility Criteria:
Inclusion Criteria: Residents working in Denmark. Participants are required to have a medical license and provide informed consent before inclusion

Exclusion Criteria:

1. No informed consent
2. Existing The Danish Society for Rheumatology (DRS) level 1 or higher.
3. Participation in prior studies involving musculoskeletal ultrasound training
To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients

This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).

The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.

One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.

The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.

The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.

The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 21 60 years of age
* Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
* Subjects with a diagnosis of RRMS for more than one year
* The subject who have signed the Informed Consent

Exclusion Criteria:

* Subjects with other causes of spasticity
* Subjects with other clinical forms of MS (different from relapsing-remitting)
Automated Deep Brain Stimulation Programming Using Functional Mapping

Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.


Eligibility Criteria:
Inclusion Criteria:

* The ability to provide informed consent
* Clinical diagnosis of idiopathic Parkinson's disease (PD)
* Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia

Exclusion Criteria:

* Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
* Not capable of functioning independently
* Individuals so symptomatic as to compromise safety
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

VasQ is an external support implant for arteriovenous fistulas created for dialysis access.

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

* Treatment arm: End to side fistula supported with VasQ
* Control: Standard of care end to side fistula

Structure

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

* Treatment arm: End to side fistula supported with VasQ
* Control: Standard of care end to side fistula

Duration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure.

Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
2. Male and non-pregnant female participants.
3. Age 18-80 years
4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.

Exclusion Criteria:

1. Index procedure being a revision surgery of an existing fistula.
2. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
4. Known central venous stenosis or obstruction on the side of surgery.
5. Pre-existing stents or stent grafts in the access circuit.
6. Planned subsequent fistula superficialization procedure.
7. Known coagulation disorder.
8. Known allergy to nitinol.
9. Expected kidney transplant within 12 months of enrollment.
10. Inability to give consent and/or comply with the study follow up schedule.
11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
12. Participation in another interventional study that in the judgment of the investigator could confound study results.
Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

This phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed NSCLC
* stage IV disease
* no progression after first line systemic therapy
* 18 to 80 years of age
* Karnofsky performance status(KPS) score ≥70%
* no contraindications to radiation therapy
* presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy

Exclusion Criteria:

* a history of thoracic surgery, radiation therapy, or more than first line chemotherapy
* pregnancy or lactation at the time of enrollment
* previous malignancy or other concomitant malignant disease
Corneal Nerve Structure in Sjogren's

Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.

Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed Sjogren's syndrome
* 18+ years of age

Exclusion Criteria:

* Any condition that in the opinion of the investigator may confound study results or cause concerns for safety
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing females.
* A positive urine drug screen.
Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years;
* Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
* Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
* Nail mycosis with an affected nail area between 20% and 50% in the target nail,
* Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)

Exclusion Criteria:

* Doubtful or negative mycological findings;
* Proximal subungual onychomycosis (PSO);
* Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
* Systemic antimycotic treatment within 12 weeks prior to screening;
* Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);
* Tinea pedis/manus at visit 1 (baseline);
* Uncontrolled diabetes mellitus
* Psoriasis
* Peripheral arterial disease
* Chronic venous insufficiency;
* Diabetic neuropathy;
* History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
* Known sensitivity to plasters.