cyrilzakka/clinical-trials huggingface dataset:
Topiramate Augmentation in Bulimia Nervosa Partial Responders

The goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment.

The aim of this study is to determine whether the addition of an augmentation medication (topiramate 200mg/d) will confer additional reductions in symptomatology in BN patients who have received six weeks of standard pharmacological treatment with fluoxetine 60 mg/day or its equivalent and had a partial response but are not in symptomatic remission.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects meeting Diagnostic and Statistical Manual IV edition (DSM-IV) diagnostic criteria for bulimia nervosa (BN).
* Subjects must be between the ages of 18 and 60 years.
* Subjects must currently demonstrate partial response to a standard BN pharmacotherapy treatment.
* Women of child-bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
* Subjects must be of good general health by history, laboratory assessment and physical exam.
* Subject's BMI must be \>20 and \<27 kg/m\^2.

Exclusion Criteria:

* Subjects who are allergic to topiramate.
* Subjects who meet DSM-IV criteria for anorexia nervosa.
* Women who are pregnant or nursing at the time of study.
* Subjects experiencing clinically significant, unstable neurological, cardiac, hepatic or renal disease or narrow angle glaucoma.
* Subjects with a history of nephrolithiasis.
* Subjects with a serum potassium \<3.0 mmol/L
* Subjects cannot start psychotherapy during the study.
* Subjects currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, or bipolar disorder.
* Subjects receiving antipsychotic agents, mood stabilizers, antianxiety agents or other non-antidepressant psychotropic agent currently.
* Subjects currently or with a history within the past year of meeting DSM-IV diagnostic criteria for substance abuse.
* Subjects who are experiencing clinically significant suicidal ideation (subjects will be referred to appropriate caregiver).
* Subjects who have participated in an investigational drug study in the past 30 days.
* Subjects who are receiving any prescription medications other than oral contraceptives that will interact with any of the study medication.
Testing the Effects of an Algorithm for Neuropathic Pain on Patient and System Outcomes

The overall purpose of this project is to improve nurse skills regarding neuropathic pain (NP) assessment, treatment and referral practices through implementation of an evidence-based algorithm and to improve selected patient outcomes as a result of algorithm use.

Neuropathic pain (NP) is defined as pain that arises from injury, disease or dysfunction of the central or peripheral nervous system. For the patient focused phase of the project NP treatment will be guided via the Peripheral Neuropathy Treatment Algorithm. Patients will receive algorithm-specific treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients experiencing NP from a variety of causes
* NP Visual Analogue Scale (VAS) score equal to or \> 4 with 12 week estimated duration
* Karnofsky Performance Status (KPS) 60% or greater
* Age greater than 18

Exclusion Criteria:

* Patients undergoing anticancer or invasive pain procedures specifically intended to palliate NP are ineligible
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
* The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab \[Humira®\] for a minimum of 5 doses on a regular schedule, etanercept \[Enbrel®\] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)

Exclusion Criteria:

* A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from the study
Nephrogenic Systemic Fibrosis With Gadollinum

Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used.

The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.

NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question.

We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.

Eligibility Criteria:
Inclusion Criteria:

* Renal Failure
* Use of Gadollinum

Exclusion Criteria:

* No consent
* Age under 18
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that:

i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation.

ii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age more than or equal to 28+0
* Postnatal age less than 28 days
* Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
* Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
* A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation

Exclusion Criteria:

* Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
* Suspicion or diagnosis of congenital heart malformations likely to require surgery
The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation

This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* one or more maxillary posterior teeth were missing, and the healing time was more than 3 months;
* complete basic information and detailed operation records;
* available CBCT images before surgery, immediately after surgery, and 6 months after surgery;
* RBH ≤6 mm shown by CBCT at T0 at the site of the missing tooth；
* no systematic diseases and no untreated periapical disease or periodontal disease before surgery.

Exclusion Criteria:

* (1) maxillary lesions have not been properly treated；
* present or past medication of bisphosphonates;
* pregnancy or lactation;
* present or past radiotherapy of head and neck cancer within 5 years;
* acute and chronic inflammation in the maxillary sinus;
* in need of additional vertical or horizontal bone augmentation besides LSFE with endo-sinus graft materials;
* heavy smoker (\>20 cigarettes/day at the time of surgery).
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer

This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.

PRIMARY OBJECTIVES:

I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.

SECONDARY OBJECTIVES:

I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.

III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.

OUTLINE:

Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
* Unilateral prostate cancer as determined by prostate biopsy
* Less than or equal to 3 positive biopsy cores
* No biopsy core \>= 50% positive for cancer
* Karnofsky performance status (KPS) \>= 70
* At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
* Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
* Clinical stage T1c or T2a
* PSA \< 10 ng/ml
* Gleason score 3+3=6

Exclusion Criteria:

* Patients who have previously received radiation therapy to the pelvis
* Refusal to sign the informed consent
* Patients who are participating in a concurrent treatment protocol
The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

This study will be carried out to examine the effect of telephone-assisted smoking cessation program on self-efficacy, smoking behavior, tumor recurrence and progression in patients with non-muscle invasive bladder cancer.

This study will be conducted to examine the effect of a telephone-assisted smoking cessation program (3 months) on self-efficacy, smoking behavior, tumor recurrence and progression for chronic disease management in patients diagnosed with non-muscle invasive bladder cancer. After 3 months of motivational interviewing was applied to the experimental group, the scales will be applied in the 3rd, 6th and 12th months. The cystoscopy will be performed at 3 and 12 months for tumor recurrence and progression

Eligibility Criteria:
Inclusion Criteria:

* Being 21 years or older
* First-time diagnosis of non-muscle invasive bladder cancer (patients with pTa urothelial cancer)
* Chronic smoking for at least 1 year
* At least primary school graduate and can speak Turkish
* Having a smartphone and internet access
* No communication barrier (speech, vision or hearing problem)
* Individuals who agree to participate in the research.

Exclusion Criteria:

* Patients with positive CIS (carcinoma in situ)
* Patients with minimal invasion of the lamina propria and above
* Patients with extravesical extension
* Patients with synchronous and metachronous tumors
* Communication disability (speech, vision or hearing problem)
Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.

The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Eligibility Criteria:
Inclusion Criteria:

* scheduled colorectal cancer surgery
* ASA I-IV

Exclusion Criteria:

* Emergency surgery
* Distant metastasis
* Patient´s refusal to participate
* Allergy or hypersensitivity to egg or soy protein
* Advanced kidney or hepatic impairment
* Severe bleeding disorders
* Congenital abnormalities of amino acid metabolism
* Hyperlipidemia and severe or difficult to control hyperglycemia
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing outpatient transurethral bulking procedures. These subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study, who oversee the patient's stress urinary incontinence management. The subjects will be asked to participate in this research project when the doctor is offering options for their SUI treatment.

Subjects will be randomized into two groups. One group will undergo transurethral bulking with TENS for analgesia, and the second group will have the procedure performed with placebo TENS. The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized. Both groups will be given the VAS, satisfaction scale, and 5-point Likert scale questionnaires to be answered before, during, and after they undergo treatment on the scheduled day of the procedure.

The primary outcome will be a change in the VAS pain measurement. Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS.

Secondary outcomes will be:

1. A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study
2. A satisfaction 10-point scale questionnaire
3. Rate of side effects to the use of TENS (skin irritation, pain or burning at electrode site) and transurethral bulking injections (vasovagal symptoms: dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, fainting),
4. Length of procedure.

Eligibility Criteria:
Inclusion Criteria:

* • Women, Age ≥18 years

  * Diagnosis of SUI
  * Scheduled to undergo transurethral bulking in the office
  * Able to read/write English

Exclusion Criteria:

* • Cutaneous damage such as ulcers or broken skin on target treatment area

  * Currently implanted cardiac pacemaker or defibrillator
  * Pre-procedural use of opioids for pain management, less than 8 hours from last dose
  * Participants with altered sensation below the umbilicus
Human-AI Collaboration for Ultrasound Diagnosis of Thyroid Nodules - a Clinical Trial

This is an experimental study wherein groups of medical students and physicians of varying degrees of experience in head-and-neck ultrasound were asked to scan the same five patients each with a thyroid nodule.

The study participants did their own ultrasound assessment of the thyroid nodules, as well as using an AI-based ultrasound diagnostics system.

The researchers intended to study two primary outcomes: 1) how varying degrees of experience in ultrasound by the operator might affect the diagnostic performance of the AI-based system, and 2) how the AI-based system influenced the diagnostic performance of the ultrasound operator.

This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.

The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input.

Eligibility Criteria:
Medical students

Inclusion Criteria:

* Last year student

Exclusion Criteria:

* Experience with ultrasound beyond that which is taught at the University of Copenhagen

Junior ENT registrar doctors

Inclusion Criteria:

* Doctor enrolled in introductory training as ENT physician.

Senior ENT registrar doctors

Inclusion Criteria:

* Doctor enrolled in ENT training.
Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts

The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.

Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
* Patient is receiving the first renal transplant
* Patient is receiving a renal transplant only
* Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
* Willing to comply with the study visits
* Be able to sign informed consent document.

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.

Exclusion Criteria:

* Previously received or is receiving an organ transplant other than a kidney
* Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
* HIV infection.
* Surface antigen positive for HBV.
* Antibody positive for hepatitis C virus
* Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
* Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
* Currently receiving any immunosuppressive agent.
* Clinically active bacterial, fungal, viral or parasitic infection
* Evidence for immunologic memory against donor.
* Recipients need antibody induction treatment before the operation.
* Current cancer or a history of cancer within the 5 years prior to study entry.
* Serious heart and lung diseases.
* Patients who's RPR is positive
* Pregnancy or breastfeeding.
* Have no ability to communicate.
* Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
One Touch VerioIQ US Clinical Outcomes Study

Evaluation of the clinical benefits of One Touch VerioIQ system

Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Eligibility Criteria:
Inclusion Criteria:

* male or female at least 18 to 80 years old
* ADA guidelines for FPG and PPG appropriate
* A1C greater or equal to 8.0% and less than or equal to 10.5%
* lab A1C greater than or equal to 8.0% in the last 6-12mths
* Diagnosed with type 1 or 2 in at least last 1 year
* on stable dose of OADs for at least 3mths prior to screening
* willingness to test 7 BGM tests per day
* willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria:

* unlikely to be compliant to study procedures
* has or has currently used One Touch VerioIQ
* Is on fixed doses of insulin for MDI therapy