cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Eligibility Criteria:
Inclusion Criteria:

* Male Age ≥ 21
* Histologically proven prostate adenocarcinoma
* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
* PSA ≤ 20 ng/ml
* Prostate volume ≤ 100 cc

Patients belonging in one of the following risk groups:

* Low:

  * CS T1b-T2a and Gleason 2-6 and PSA ≤ 10
* Intermediate:

  * CS T2b and Gleason 2-6 and PSA ≤ 10, OR
  * CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml

Exclusion Criteria:

* Any histology other than adenocarcinoma
* Age \< 21
* KPS \<= 40 \<70
* ECOG Performance Status ≥ 2
* Patient weight \>350 lbs. (table limitation)
* Prior XRT to prostate or lower pelvis
* Prior surgery or cryotherapy to prostate
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
* Chemotherapy for a malignancy in the last 5 years
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
* Hormone ablation for 2 months prior to enrollment, or during treatment
Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
* pre-procedure psychological clearance

Exclusion Criteria:

* younger than 18 years
* prior neuromodulation including spinal cord stimulation
* prior dorsal root ganglion stimulation
* prior peripheral nervous system stimulation
* anatomical obstacles to dorsal column lead placement
An Observational Study Evaluating Cholesterol Levels in Patients on Cholesterol Lowering Drugs in Jordan and Lebanon

This was a multicenter survey of patients who were on lipid -lowering pharmacological treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan and Lebanon.

Data collected from each patient took place at a single visit. Each participating doctor filled the investigator questionnaire on his/her experience and perception of the management of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals and the various treatment options for high cholesterol in blood.

Before being assessed by the investigator, patients recorded, on the patient questionnaire, their awareness of high blood cholesterol , their current lipid-lowering treatment schedule, their understanding of their condition and compliance in taking the medications on time.

The investigators completed a Patient Record Form (PRF) with the patient's basic information, cardiovascular risk factors and the cardiovascular medical history, current lipid lowering drug treatment and the reason for the current therapy.

A blood sample under fasting condition was drawn from each subject. A central laboratory in Jordan received all samples. Every sample was analyzed for its cholesterol blood level, fasting sugar level and hemoglobin A1C levels.

CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with high cholesterol blood levels willing to participate in the study
* Patients must be on cholesterol lowering medications for three months with no dose change for six weeks

Exclusion Criteria:

* Patients not on cholesterol lowering medications or on medications for less than three months
* Any medication dose change in six weeks prior to their visit
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax

The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;
* Able to comprehend and sign an informed consent form;
* Willing and able to complete all postoperative visits;
* Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
* Intended treatment targeted for emmetropia;
* Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or lactating, current or planned, during the course of the study;
* Dry eye;
* Corneal disease;
* Diagnosis of advanced glaucoma;
* Uncontrolled diabetes;
* Other protocol-defined exclusion criteria may apply.
Prostate Cancer Screening Trial Using Imaging

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:

1. Bi-parametric MRI - reported by a radiologist and CAD-AI system
2. Multiparametric ultrasound - including shearwave elastography
3. A standard-of-care PSA test

A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.


Eligibility Criteria:
Inclusion Criteria:

1. Men aged between 50 and 69 years inclusive at the time of study entry
2. Participants must be fit to undergo all procedures listed in the protocol
3. Estimated life expectancy of 10 years or more
4. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
5. Participants must be willing and able to provide written informed consent

Exclusion Criteria:

1. Previous PSA test or prostate MRI within the prior two years of screening/consent visit
2. Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months
3. Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
4. Any potential contraindication to MRI
5. Any potential contraindication to prostate biopsy
6. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
7. Any other medical condition precluding procedures described in the protocol
PACT Involvement in Cardiology Patients

The goal of this trial is to determine the effectiveness of a machine-learning (ML) model predicting a serious cardiac event within the next three months, when compared pre- versus post-deployment, in pediatric cardiac inpatients. The main questions it aims to answer are whether deployment of the ML model:

1. Increases PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days
2. Increases PACT consultation or visit within the next three months among those who experience a serious cardiac event during this period
3. Decreases time to PACT consultation or visit among those seen by PACT during this period
4. Decreases the incidence of death in the intensive care unit (ICU)
5. Increases documentation of goals of care

High-risk cardiology patients will be identified by an ML model each morning. If the patient has been seen by the PACT team within the past year, the update will go to the PACT team members. If the patient hasn't been seen by the PACT team, the email will be sent to the cardiology physician in charge of the patient. This physician will decide whether a PACT consultation is necessary based on their clinical judgment. If so, a referral will be made using the usual process. Outcomes of the identified patients will be compared pre- and post-deployment.

At The Hospital for Sick Children (SickKids), the collaboration between cardiology and palliative care is much stronger than other centers, with routine involvement in patients being considered for heart transplant. Despite this, earlier involvement of palliative care would be advantageous. Our cardiology co-investigators identified patients who would benefit from earlier palliative care team involvement as those receiving advanced heart therapies (defined as ventricular assist device (VAD) and being wait listed for heart transplant) and those who die. The study team created a clinical deployment environment named SickKids Enterprise-wide Data in Azure Repository (SEDAR). \[1\] SEDAR is a modular and robust approach to deliver foundational data that is re-usable across multiple ML projects. It offers validated EHR data in a standardized and curated schema. ML is a promising approach to identify cardiac patients at the highest risk of these serious cardiac outcomes who may benefit from earlier palliative care team involvement. To assess the effectiveness of this approach, patient outcomes will be compared pre- and post-deployment of the ML model. The pre-period will include patients admitted for a 12-month period before deployment (starting 15 months prior to deployment). The post-period will include patients admitted for a 12-month period following deployment starting 3 months post-deployment start.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric inpatients admitted to cardiology

Exclusion Criteria:

* Expected to be discharged prior to midnight on the day of admission
Improving Access To Services to Community Based Outpatient Clinics (CBOC's)

The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).

We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.

Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable)

Exclusion Criteria:

* Current substance dependence
* psychosis
* symptomatic bipolar disorder
* severe depression with suicidal intent or plan
Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base

This study aims to evaluate the feasibility of monitoring the blood glucose values by measuring the glucose in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects with type 1 or 2 diabetes mellitus (any therapy form).

The clinical investigation will be performed in an outpatient setting on up to two study days with up to 100 subjects. A nearly equal number of subjects with diabetes type 1 and 2 shall participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 or type 2 diabetes
* HbA1c \<10%
* An understanding of and willingness to follow the protocol
* Signed informed consent

Exclusion Criteria:

* Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
* Hypoglycemia unawareness
* Have extensive skin changes/diseases at the proposed measurement site (wrist) that could interfere with the accuracy of glucose measurements.
* Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
* Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
* Severe diabetes related complications (i.e. severe macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy
* Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse
* Not able to understand, write or read German
* Dependency from the sponsor or the clinical investigator
Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.

A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.

Eligibility Criteria:
Inclusion Criteria:

* \< 39 years old on day of randomisation
* FSH \< 12 (in the early follicular phase)
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
* BMI between 18 and 29 (both inclusive)
* 1st or 2nd trial
* IVF or ICSI
* Randomisation at out-patient clinic

Exclusion Criteria:

* ≥ 39 years old on day of randomisation
* Endometriosis ≥ grade 3
* PCOS
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

The study comprised of two parts:

* In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
* In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female from 1-3 years of age;
* Physician-diagnosed peanut allergy;
* Peanut-specific IgE level \> 0.7 kU/L;
* Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
* Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

* Uncontrolled asthma;
* History of severe anaphylaxis to peanut;
* Prior immunotherapy to any food or other immunotherapy;
* Generalized severe dermatologic disease;
Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.

Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.

Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.

Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
2. Children between ages of 5 to 15 years
3. Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes

Exclusion Criteria:

1. Immunocompromised children
2. Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
3. Children with liver or renal failure
4. Children who were already using any oral or parenteral antibiotics
A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema

The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* A diagnosis of head and/or neck lymphedema
* Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation
* Head and chest measurements within the following:
* Crown of head circumference: ≤ 72 cm
* Chest circumference: ≤ 158 cm
* Prescribed the Flexitouch system or Flexitouch Plus

Exclusion Criteria:

* Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression)
* Carotid sinus hypersensitivity syndrome
* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
* Symptomatic bradycardia in the absence of a pacemaker
* Internal jugular venous thrombosis (within 3 months)
* Increased intracranial pressure or other contraindications to internal or external jugular venous compression
* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative
* Facial or head and neck dermal metastasis
* Acute facial infection (e.g., facial or parotid gland abscess)
* Any condition in which increased venous and lymphatic return is undesirable
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Subject is pregnant or trying to become pregnant
* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies

Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.


Eligibility Criteria:
Inclusion Criteria:

* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
* related to children
* and reported, or not, cancer therapy-related cardiac dysfunction

Exclusion Criteria:

* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients
Effects of Brain Beta-Amyloid on Postoperative Cognition

Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients greater than or equal to 65 years of age.

This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects scheduled for hip or knee replacement.

The investigators hypothesize that preoperative beta-amyloid plaques will predict postoperative cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for total knee arthroplasty or total hip arthroplasty under general anesthesia (primary arthroplasties and revisions)
* English speaking
* Anticipated stay in the hospital
* Not anticipated to stay intubated postoperatively
* Patients who live with or have regular visits from an individual ("study partner") willing to provide information about the patient's cognitive status
* Willing and able to undergo all testing procedures including neuroimaging and agree to longitudinal follow up
* Adequate visual and auditory acuity to allow neuropsychological testing
* Subjects with Clinical Dementia Rating Scale (CDR) of 0-0.5
* Patients who are not demented
* Subjects sho signed an IRB approved informed consent prior to any study procedures

Exclusion Criteria:

* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject
* Current clinically significant cardiovascular disease.
* History of drug or alcohol abuse within the last year, or prior prolonged history of abuse
* Clinically significant infections disease, including Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive test for hepatitis
* History of relevant severe drug allergy or hypersensitivity
* Received an investigational medication under an FDA IND protocol within the last 30 days.
* Current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject
* Received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
* Severe psychiatric disorders including schizophrenia, bipolar disorders, and major depression as described in DSM-IV within the past year (medical record, GDS score, interview with the patient and study partner)
* Obvious causes for their cognitive impairment (e.g. onset coincides with recent head trauma or stroke)
* Dementia of any cause
* CDR score \> 0.5
* Expressed the preference to undergo the procedure under regional anesthesia in form of spinal or epidural anesthesia
* Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type