cyrilzakka/clinical-trials huggingface dataset:
NeuroVision vs Standard Neuromonitoring

The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.

Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.

Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
* Patients able to provide informed consent

Exclusion Criteria:

* Active infection
* Active or history of malignancy
* Spinal traumatic injury within the past 2 years
Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus

Diet management could improve blood and weight control in patients with diabetes mellitus. Time-restricted feeding is a novel dietary tool that limits time of energy intake without altering diet quality or quantity. This study aims to assess the effect of 10-hour time-restricted feeding on metabolism and behavior in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus
2. HbA1c 7.0% to 8.5%
3. BMI ≥ 24 kg/m2
4. Time of energy intake ≥ 12 hours per day, ≥ 4 days per week
5. Ability to use smart phone and app, to follow study protocol
6. Sign informed consent

Exclusion Criteria:

1. Use insulin, long-acting insulin secretagogues, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor
2. Suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease
3. Work state affect eating time: constant night duty, constant long-haul international travel
4. Smoking
5. Drinking
6. Severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia
7. Suffered from infectious disease: pulmonary tuberculosis, AIDS
8. Dyskinesia
9. Body weight change ≥ 5 kg in the past 3 months
10. Hospitalized in the past 3 months
11. Used antibiotics for ≥ 3 days in the past 3 months
12. Diagnosed with type 1 diabetes mellitus
13. Pregnancy, lactating
14. Participating in other clinical trials in the past 1 months
REWARDS-Angina at Follow up Post Stenting

Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation.

The objective of this study is to retrospectively identify the rate of angina (any as well as CCS class III/IV) up to one (1) year following stent implantation. The following drug eluting stents will be evaluated in addition to bare metal stents; Cypher, Taxus Express, Xience V, Resolute and Promus Element. The target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, \> 18 years of age,
* Patients who received at least one (1) commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents

Exclusion Criteria:

* Received more than one type of DES as listed above or both a BMS and DES (as listed above)
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort

Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases.

Agreement between cervical and oral HPV infection has been described from a small group of patient. Our study, performed on a greater number of patients, will provide a good estimation of this link, between cervical and oral infection, in a French population of women with a primary cervical HPV infection.


Eligibility Criteria:
Inclusion Criteria:

* Histologic proven of cervical intraepithelial neoplasia or carcinoma in situ (CIS) or invasive cervical cancer or a Pap smear on which at least one HPV has been detected
* Patients not vaccinated against HPV
* Age \>18 years
* EOCG performance status ≤ 3
* Patient must be affiliated to a social security system
* Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion Criteria:

* Patients vaccinated against HPV
* Pregnant woman over 10 weeks
* Patient who underwent head and neck radiotherapy dating less than one year
* Patients deprived of liberty or under supervision
SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer

The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer.

Peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sCT), or supportive care .Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.

Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred

Peritoneal metastasis of colorectal cancer

At least one uni-dimensional measurable lesion by RECIST criteria

Age 18 to 80 years old

Estimated life expectancy ≥3 months

ECOG performance status ≤2

Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)

Adequate kidney function (creatinine \< 1.5 mg/dL)

Adequate liver function (bilirubin \< 2.0 mg/dL, transaminase levels \<2.5 times the upper normal limit)

Written informed consent

Exclusion Criteria:

Other tumor type than adenocarcinoma

Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)

Presence of CNS metastasis, psychosis, or seizure

Obvious bowel obstruction

Evidence of serious gastrointestinal bleeding

Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

Pregnant or lactating women, women of childbearing potential not employing adequate contraception

Other serious illness or medical conditions
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome

A prospective randomised controlled trial to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

To investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* histologically-proven pre-operative stage I-III gastric cancer
* Combined with metabolic syndrome
* Age limits from 18 to 80 years old
* Classified into American Society of Anesthesiology (ASA) II or III surgical risk
* no history of abdominal surgery on organs located at the abdominal supramesocolic level

Exclusion Criteria:

* Combined with severe cardiac or pulmonary disease or other organ dysfunction
* ASA IV
* The history of abdominal surgery
* Conversion to open surgery
* The presence of gastrointestinal obstruction, perforation or necrosis;
* Declined to participate in this study
Pediatric FN Definition 2012 Bern

STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer

* to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures
* to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C)
* to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)
* to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis)
* to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN

HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would

* increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).
* increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6).
* not relevantly decrease the proportion of FN with AE (secondary endpoint 7).


Eligibility Criteria:
Inclusion Criteria:

* \>1 year and ≤17 years at time of recruitment
* Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment
* Written informed consent from patients and/or parents for the study

Exclusion Criteria:

* Infants ≤1 year old (reason: differences in standard fever limit and method to measure temperature)
* Denied written informed consent from patients and/or parents for the study
Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 19 years of age
* Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
* Other exclusions applied
Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability

Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).

The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability.

The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 17 years
* Presence of intellectual disability
* Need of peripheral IV line or venipuncture
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Presence of abrasion, infection or break in skin in the area of Buzzy® placement
* Cold hypersensibility
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

Exclusion Criteria:

* Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.
No Surgery Trial / Two Dose-escalation Strategies

A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
* Rectal cancer staged as N0 by MRI or EUS/TRUS
* No metastatic lesion
* Rectal tumor occupying less than half of the circumference
* Tumor less than 5 cm on its largest dimension
* Tumor located at less than 10 cm from the anal verge
* Tumor penetration less than 5 mm in the mesorectal fat
* Tumor accessible for brachytherapy
* Lumen accessible for colonoscopy
* Patient should be a suitable candidate for brachytherapy and chemotherapy
* Older than 18 years of age
* Adequate birth control measures in women of childbearing potential
* Written informed consent

Exclusion Criteria:

* Patients with previous pelvic radiation
* Evidence of distant metastasis
* Extension of malignant disease to the anal canal
* Tumors staged as T4
* Tumors larger than 5 cm in length
Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients

For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient suspicious of active tuberculosis with immunocompromised condition
* Immunocompromised condition patients with

  1. solid cancer with chemotherapy
  2. hematologic malignancy
  3. organ transplantation
  4. immunosuppressant
  5. ESRD on renal replacement therapy
  6. diabetes
  7. advanced liver cirrhosis

Exclusion Criteria:

* Patients with

  1. less than 20 years
  2. who don't agree the participation of study
  3. hypersensitivity history to tuberculin
  4. pregnancy
Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy


Eligibility Criteria:
Inclusion Criteria:

* symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria:

* myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid
Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell lung cancer cells.

PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer.

OBJECTIVES: I. Determine the response rate and median duration of response of interleukin-2 (IL-2) in patients with previously treated non-small cell lung cancer. II. Determine the median survival of patients treated with IL-2. III. Further delineate the toxicity of IL-2 in these patients.

OUTLINE: This is an open label study. Patients receive bolus interleukin-2 on days 1-5 and 8-12. The cycle repeats every 3 weeks. Patient response is evaluated after 2 cycles. Patients with stable disease, partial, or complete response may be treated with maintenance IL-2 for up to 4 additional cycles. Patient evaluation is performed after every 2 cycles. At this point, patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete response.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-small cell lung cancer At least one prior systemic therapy OR prior radiation therapy Must have measurable disease Previously irradiated sites of disease are not considered evaluable unless there is radiologic documentation of progression

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No prior history of myocardial infarction within previous 6 months No uncompensated congestive heart failure No primary (not due to electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions Pulmonary: No dyspnea at rest or need for supplemental oxygen Patients with symptomatic lung disease or extensive lung metastases must have oxygen saturation greater than 90% Other: Not pregnant or nursing Negative pregnancy test Patients with elevated temperatures greater than 100.5 F must have no occult infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent cyclosporin Chemotherapy: At least 3 weeks since chemotherapy and recovered No concurrent methotrexate See Disease Characteristics Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since radiotherapy See Disease Characteristics Surgery: Not specified
Designing a Mobile App for Veterans With Substance Use Problems

The purpose of this study is to increase access for rural Veterans to evidence-based, person-centered, individually tailored treatment for alcohol use problems. The primary aim is to evaluate the acceptability and feasibility of using mobile technology deliver treatment for alcohol use disorder. A mobile application will be used replacing the usual setting of clinical visits that accompanies standard face-to-face CBT therapy. The application will be loaded onto an iPod, which will be distributed to each participant that has been found to be eligible to participate.

Many Veterans returning from Iraq and Afghanistan experience problems with drinking. There are treatments for alcohol use disorders that can be very helpful, but sometimes it can be hard for Veterans to find or participate in the treatments. This can be because of the amount of time the treatments take and the long distance to places where substance abuse treatments are offered. For Veterans who live in rural areas, these types of issues can pose even bigger problems. To address these issues, new types of treatments and ways of delivering care are being studied.

We have developed a mobile application that will be accessed through the use of a mobile device such as an ipod. The application will contain an application dedicated to the treatment of substance abuse disorders. This application will provide the coping skills and educational information to aide in helping with problems associated with drinking alcohol.

Eligibility Criteria:
Inclusion Criteria:

1. Veteran of the Armed Forces
2. are part of the primary care - mental health (PC-MH)
3. reside in a rural community, as defined by the US Census Bureau
4. score greater than or equal to 8 on the Alcohol Use Disorder Identification Test (AUDIT)
5. meet diagnostic criteria for alcohol abuse or dependence as assessed by the Mini International Neuropsychiatric Inventory (MINI) according to the Diagnostic and Statistical Manual (DSM-IV)
6. Age 18 and older to participate. -

Exclusion Criteria:

1. Have conditions that threaten your safety (e.g., active suicidal intent, current uncontrolled psychosis or bipolar disorders in the past month as assessed by the MINI).
2. Veterans with a diagnosed concurrent substance dependence (other than nicotine) and more than mild risk of alcohol withdrawal based on a score of greater than 8 on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) will be excluded.

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