cyrilzakka/clinical-trials huggingface dataset:
MRI Characterization of Mammographically Detected DCIS

This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).

The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.

The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.

The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).

Eligibility Criteria:
Inclusion Criteria:

* \[Cohort A\] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
* \[Cohort B\] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy

Exclusion Criteria for Both Cohorts:

* Patients with prior history of breast cancer in the ipsilateral breast
* Patients with a newly diagnosed breast cancer in the contralateral breast
* Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR\<60, contrast allergy, incompatible metal)
* Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
* Women who are pregnant
Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

The diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. However, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. Patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. These cases have been described in the medical literature as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.

Because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso Mental Balance Technology) developed to alleviate the feelings of dizziness.

Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!


Eligibility Criteria:
Inclusion Criteria:

* Age: 18≤ years ≤85
* Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder.
* Stable symptoms for more than one month and less than a year.
* Ability to perform all tests (including computerized test) and interviews.
* Gave informed consent for participation in the study.

Exclusion Criteria:

* Dizziness disease with fluctuating symptoms such as in active Meniere's disease or Benign Paroxysmal Positional Vertigo
* CNS disease or injuries
* Dizziness caused as a result of previous whiplash
* Any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.)
* Pregnant women
* Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
Japan Early Diabetes Intervention Study

The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG \<= 125 mg/dL, 2-h PG \>= 200 mg/dL and HbA1c \<= 6.9%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Undergoing treatment with steroids
* Secondary diabetes mellitus
* Diabetes mellitus due to suspected gene abnormalities
* BMI \>= 35 kg/m2 or BMI \< 18.5 kg/m2
* Undergone a surgery
* Severe hyperuricemia (gout) associated with organ dysfunction
* Severe vascular diseases with organ dysfunction
* Cancer or other malignant neoplasms
* Liver cirrhosis or chronic hepatic, chronic renal failure
* Gastrointestinal disorders
* Always performing rigorous muscular exercise
* Severe infection or serious trauma
* Women who are pregnant
* Alcohol dependence or drug dependence
* Drug allergy
* Anemic
* Abnormal hemoglobinuria
* Severe mental disease
PRICO: OPTI Target Range

The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range

A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.

The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.

Eligibility Criteria:
Inclusion Criteria:

* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.

Exclusion Criteria:

* Informed consent is not obtained
* Recording device for automated control of FiO2 is not available
Study of Multiple Doses of Saxagliptin (BMS-477118)

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes who are drug-naive
* Screening HbA1c ≥ 6.8% and ≤ 9.7%
* Screening fasting or random C-peptide \> 0.5 ng/mL
* \< 35 years old must be negative for anti-GAD antibodies
* Body Mass Index \< 35 kg/m2

Exclusion Criteria:

* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
* Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
* Significant cardiovascular history
Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures.

Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Scheduled for acute- or elective laparoscopic cholecystectomy
* Informed consent

Exclusion criteria:

* Known iodine-hypersensitivity
* Liver- or renal insufficiency
* Known thyrotoxicosis
* Pregnancy or lactation
Audiobook Application in Patients Receiving Hemodialysis Treatment

This research will be conducted to evaluate the effects of audio book application on anxiety, depression and quality of life in patients receiving hemodialysis treatment.

Hemodialysis is an extracorporeal blood purification technique used to remove accumulated metabolic waste products in patients and is a frequently used treatment method in patients with end-stage renal disease.

Although hemodialysis, which is one of the treatment of end-stage renal disease, prolongs life, it can also lead to various psychological disorders such as depression, anxiety and severe stress. Psychological disorders and depression in dialysis patients often manifest as a response to loss of ability to work and earn an income, decreased energy, decreased sexual function, other limitations caused by physical disability, and reduced life expectancy.

Depression is the most common psychopathological condition in patients with end-stage renal disease. The rate of depressive symptoms among dialysis patients is high and its prevalence is up to 43%, and it is stated that it has a significant effect on quality of life. The psychological and somatic effects of depression can complicate the course of the chronic disease.

Reading books is one of the tools to heal mental disorders. Some individuals cannot read on their own due to aging, poor eyesight, or lack of literacy. An audiobook is a recording of a book read by an author, actor, celebrity, or amateur. Audiobooks are recommended for their friendliness, comfort, and emotional impact. Audiobooks are recommended to increase the quality of life of individuals and to protect social health.

This research will be conducted to evaluate the effects of audio book application on anxiety, depression and quality of life in patients receiving hemodialysis treatment.

Patient information form, hospital anxiety depression scale, SF-36 quality of life scale will be used to collect research data.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old,
* Receiving hemodialysis treatment for six months or longer,
* Receiving hemodialysis treatment three times a week,
* No problem with the sense of hearing,
* Has no handicap in answering the questions physically and mentally,
* No verbal communication disability (hearing and speaking),
* Can understand Turkish,
* Not having been diagnosed with a mental illness,
* Patients willing to participate in the study will be recruited

Exclusion Criteria:

* Those who want to withdraw from the research
Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial

Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese individuals, and 30% to 50% of those participating in weight loss programs. BED, the most common eating disorder, is characterized by over-eating with loss of control (i.e., binge eating), but with no purging (e.g., vomiting).Our previous research indicates that the total health care costs for women with BED is 36% higher than the Canadian average for women of a similar age, and that health care costs significantly decreased following intensive treatment at our Centre. The main goal of our study is to inform the development of a stepped care approach to the treatment of BED. Stepped care involves providing easily accessible low intensity treatment first, and then providing more expensive intensive treatment second, if necessary. The second goal is to assess if a second more intensive step of treatment provides added value. Although stepped care for BED is suggested by a number of clinicians and researchers, no study adequately tests predictors of who might benefit from minimal treatment alone and who would require the more intensive second step. The results of this study will guide decision making regarding who benefits from stepped care, and will help to increase the accessibility, availability, and cost effectiveness of psychological treatments for BED.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be included if they:

  1. are comfortable speaking or reading English;
  2. do not have a history of an eating disorder other than BED, or a history of significant purging behaviour;
  3. do not have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
  4. are not currently or planning to be enrolled in a weight-loss program within the next year;
  5. are women who are not pregnant or planning to be pregnant within the next year; and
  6. are not currently or planning to be enrolled in other psychotherapies within the next year

Exclusion Criteria:

* Participants will be excluded if they:

  1. are not comfortable speaking or reading English;
  2. have a history of an eating disorder other than BED, or a history of significant purging behaviour;
  3. have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
  4. are currently or plan to be enrolled in a weight-loss program within the next year;
  5. are women who are pregnant or planning to be pregnant within the next year; and
  6. are currently or plan to be enrolled in other psychotherapies within the next year
Pilot Feasibility Study of Peristomal Adhesives

Loss of voice is one of the greater consequences of total laryngectomy. The voice prosthesis allows the patients to speak again in a very short time but forces them to use one hand when speaking. In order to reduce this discomfort and to allow "hands-free" speaking, an Automatic Speaking Valve (ASV) has been designed which is positioned on a peristomal adhesive.

Peristomal adhesives, however, tend to detach under the influence of mucus, cough, or phonatory pressure. Consequently, the current regular use of the automatic speaking valve in laryngectomees is very low. As a possible solution, Atos Medical AB has developed a moldable peristomal adhesive made of a thermoplastic elastomer, which becomes transparent and moldable when heated and facilitates precise contouring in situ. As the material cools, it loses its malleability but retains the integrity of the molded shape.

The expectation was that the moldable adhesive would provide a better individual fit and therefore longer fixation (especially when using the ASV).

To study the feasibility of this device, 10 total laryngectomized patients were asked to use the new moldable peristomal adhesive for two weeks in conjunction with their normal daily routine for adhesive application and removal, and speech rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone total laryngectomy
* Over the age of 18
* voice prosthesis user
* Experience in the use of adhesive and HMEs
* At least 3 months after total laryngectomy
* At least 6 months after the end of adjuvant radiotherapy
* Signature of the informed consent

Exclusion Criteria:

* Medical issues that prevent the use of HMEs and/or adhesives
* Recurrent or metastatic active disease
* Reduced mobility of the arms and/or hands
* Inability to understand the information and/or to provide informed consent
* Insufficient cognitive ability to handle HME or moldable adhesive
An Extension of the TG1101-RMS201 Trial

This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

* Subjects currently enrolled in TG1101-RMS201 trial
* Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit

Exclusion Criteria:

* Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
* Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
* Pregnant or nursing mothers
Acetaminophen and Post Circumcision Pain Control

Infants do not routinely receive acetaminophen for pain control after circumcision. This study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. Infants will undergo the routine circumcision procedure, and half will be randomly selected to receive half acetaminophen immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate, respiratory rate, oxygen saturation), the neonatal infant pain scale (NIPS), and salivary cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated pain scoring system based on the appearance of the infant. A reduction in NIPS for those infants who receive acetaminophen versus nothing will be the primary outcome to determine if the study is significant.

Male circumcision is a common surgical procedure performed in the newborn period. The American Academy of Pediatrics Task Force on Circumcision recently published an update on circumcision policy stating the benefits of male circumcision outweigh the risks. Given this update, the investigators anticipate a percentage of families who were previously undecided about circumcision will choose to have their newborn circumcised. A common concern for both parents and physicians is effective pain control. For intra-operative pain control, dorsal penile nerve block (DPNB) has been found to be the most effective when compared to EMLA (lidocaine-prilocaine) or placebo. Acetaminophen is a relatively safe, easy to administer analgesic. Prior studies have suggested that acetaminophen could be helpful in postoperative comfort. However, studies examining the effectiveness of acetaminophen for postoperative pain control in infants who received DPNB are lacking. In addition, prior studies have been incomplete in the assessment of neonatal pain.

Eligibility Criteria:
Inclusion Criteria:

Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes

1. Apgar score at 5 minutes \>7
2. birthweight greater than 2.4 kg
3. Age of at least 10 hours
4. At least one void.

Exclusion Criteria:

1. Newborns of substance abusing mothers.
2. Newborns with any contraindications to routine circumcision, anatomical or hematologic.
Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing

The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital

Exclusion Criteria:

-
Differences in Pain Processing Between Men and Women

Many chronic pain conditions show clear differences between between men and women, such as reported pain intensities or treatment effects, with chronic pain conditions being generally more frequent in women. Yet, the underlying mechanisms causing these differences are poorly understood. Central sensitization (CS) is considered one important mechanism in pain patients which differs between female and male patients. The central hypothesis is that already in the healthy population CS processes are more pronounced in women than in men.


Eligibility Criteria:
Inclusion Criteria:

* good general health
* able to give informed consent

Exclusion Criteria:

* pain complaints for more than two consecutive days over the past three months
* any major medical or psychiatric condition (e.g. heart disease, major depressive disorder)
* any chronic pain condition
* inability to follow study instructions
* consumption of stimulants, drugs, or analgesics within the past 24 hours
* scar tissue or generally reduced sensitivity in the designated testing site areas
Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals for whom treatment with Epidyolex has been initiated by a physician with experience in the treatment of epilepsy.
* The participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.

Key Exclusion Criteria:

* Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
Reduced Chemotherapy in Low Risk DLBCL

This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21
* Age\>=14 y.o.,\<=75 y.o.
* IPI=0-1
* non-bulky (largest diameter \<7.5cm)
* ECOG =0-1
* Life expectancy\>6 months
* Informed consented

Exclusion Criteria:

* Chemotherapy before
* Stem cell transplantation before
* History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary cutaneous, CNS DLBCL
* LVEF≤50%
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Lab at enrollment(unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<80\*10\^9/L Hemoglobulin\<100g/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN
* Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
* HIV infection