cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

This study involves several innovations including :

* the robotization of the confocal miniprobe for a better an d more precise handling of the probe
* the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
* the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
* patient able to give written informed consent

Exclusion Criteria:

* allergy to fluorescein
* allergy to patented blue
* allergy to ICG
* previous life-threatening allergic reactions and known hypersensitivity
* pregnancy or breast-feeding
* history of cardio-pulmonary disease (including bronchial asthma)
* restricted renal function
* patient under a beta-blockers treatment
* patient who cannot give written informed consent
The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial

This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.

In this study the effects of a single- or multiple whole body cryotherapy (-135°C for max. 2 minutes) vs. cold water immersion (10°C for 15 min) and a passive control group (20 min supine position) are compared. These effects are examined after a muscle damage protocol of the frontal thighs (3 x 30 jumps). The objective recovery parameters are vertical jump, maximum voluntary contraction of the anterior thigh muscle, heart rate, blood pressure, skin-core body temperature and the oxygen saturation of the thigh muscles. Subjective recovery parameters are the local muscle soreness details and the general exhaustion details. The parameters are directly and 24, 48 and measured 72 hours after exposure. The aim is to elicit the effects of whole body cooling to make recommendations to. The current scientific knowledge situation calls for further studies to whole body cooling.

Eligibility Criteria:
Inclusion Criteria:

Only healthy young subjects 18-35 years no musculoskeletal surgery in trunk and lower extremities injury history in trunk and lower extremity for more than one year subjects taking anticonceptive medication are allowed to participate

Exclusion Criteria:

Actual injuries or injuries for less than one year in trunk and /or lower extremities injury history in trunk and lower extremity for more than one year with complaints anxiety of cooling subjects on medication pace maker cardiovascular disease pregnancy skeletal problems appendectomy for less than two years Morbus Raynaud syndrome
Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby

A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant

Transition to motherhood, being one of the most important life incidents in the lives of women embodies the transition of role from a known situation to an unknown one. Being a special period in which women hold the role of motherhood together with the birth of the child; try to adapt the new role and reform relationship with the family members at the same time, transition to motherhood is a progressive period experienced by many women. Transition of woman to motherhood in a healthy manner will positively affect developing trust, achieving healthy communication with the infant, adapting to new lifestyle and fulfilling her responsibilities. Thus, transition to motherhood is quite significant both for mother and other family members and the new-born infant and needs to be discussed.

It is aimed in this research that effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant shall be tested.

It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of adaptation to pregnancy, adaptation to the postpartum period and newborn perception.

Eligibility Criteria:
Inclusion Criteria:

* Living in Aydın
* Between the ages of 18-35
* Have no children
* Gestational week is 28 weeks (beginning of 3rd trimester)
* Having a single pregnancy
* At least primary school graduate
* Not risky of pregnancy
* Have no chronic disease
* Can speak and write Turkish language

Exclusion Criteria:

* Having a history of mental and mental health problems
* With speech and hearing impairments
* Having a risky pregnancy
* Having multiple pregnancies
GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above the normal range
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at the time of screening of either sex or any race;
* Provide written informed consent;
* Be willing and able to follow instructions, and can attend all required clinical trial visits.
* Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
* Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Exclusion Criteria:

* Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
* Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
* Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
* Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
* Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.
Role of Multi-detector CT and MRI in Diagnosis of Congenital Inner Ear Anomalies

Evaluation of combined value of Multi-detector computed tomography (MDCT) and Magnetic resonance imaging (MRI) in the diagnosis of congenital abnormalities of the inner ear and internal auditory canal in patients with congenital hearing loss and preoperative evaluation of cochlear implant candidates.

Introduction:

Inner ear malformation (IEM) with associated sensoryneural hearing loss (SNHL) is a major cause of childhood disability.

The embryology of the inner ear must be known as many of the inner ear malformations present as a result of the arrest during the various stages of embryology.

Congenital malformations of the inner ear may be considered in two broad categories:

1. malformations with pathologic changes that involve only the membranous labyrinth.
2. malformations that involve both the osseous and the membranous labyrinth.

Congenital sensorineural hearing loss arises as a result of abnormalities in the inner ear, the vestibulocochlear nerve, or the processing centres of the brain. The abnormality may have a genetic cause or be a sequel of infection or injury at birth; in some cases, no cause is identified.

One of the paths in the investigation of congenital sensorineural hearing loss (CSNHL) is to try to characterize its aetiology through the inner ear evaluation using high resolution computer tomography (CT) scans. With minor malformation, it is not always possible for a simple visual inspection to recognize if the structure in the inner ear is normal or not.

Both CT and MR can be used to look at inner ear malformations but often both techniques are complementary. CT is preferred when associated middle or external ear malformations must be excluded. Magnetic resonance is preferred when subtle changes in the membranous labyrinth or abnormalities of the nerves in the internal auditory canal must be visualised Moreover, some changes inside the membranous labyrinth can only be seen on sub-millimetric heavily T2-weighted MR images.

Only MR can demonstrate the abnormal course, hypoplasia or aplasia of the vestibulocochlear nerve (or one of is three branches) and facial nerve.

HRCT and MRI temporal bone are complementary to each other in evaluating children for cochlear implantation as HRCT is excellent for demonstrating bony details but, lack in providing details of inner ear neural structures and MRI is better than CT in demonstrating vestibulocochlear nerves.

Combined HRCT and MRI studies are mandatory for evaluation of inner ear, the radiologist must be familiar with imaging findings that absolutely contraindicate implantation (Cochlear aplasia, cochlear nerve aplasia and labyrinthine aplasia), and with those that relatively contraindicate implantation (labyrinthitis ossificans, other inner ear dysplasia) and with other findings that could significantly alter or complicate surgery (hypo plastic mastoid process, facial nerve dehiscence, oto-mastoiditis)

Eligibility Criteria:
Inclusion Criteria:

* all patient of inner ear anomalies

Exclusion Criteria:

* studied groups ,mri
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs

The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence. Fifty people who inject drugs (PWID) were prescribed PrEP and randomized to one of two conditions, Twenty-five PWID participated in a standard HIV prevention session and 25 other PWID participated in a HIV prevention session with the included accommodation strategies. At recruitment participants were asked to provide self-report of the screening form and cognitive functioning. The intervention consisted of a total of 5 sessions: 1 meeting to gain baseline information of participants and 4 intervention sessions. Participants completed the consent form, demographics, skills assessment, drug use behavior assessment, and HIV risk behavior assessment at the pre-interview meeting. Participants completed PrEP uptake assessments and skills assessments immediately following the intervention to compare the pre/post results between the two groups. All participants also completed an acceptability rating to help researchers determine the acceptability of the accommodation strategies used, at the end of the 4th session. The objective was to determine if the proposed accommodation strategies are feasible and efficacious at improving HIV prevention outcomes, including knowledge and skills. Information gleaned from this process will be used to refine the intervention approach for future testing and implementation.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years or older
* reported injection drug use in the past 30 days
* reported engagement in drug- and/or sex- related HIV risk behaviors
* HIV negative
* are willing to initiate PrEP use
* can communicate (read, write and speak) in English
* experience mild/moderate level of cognitive dysfunction

Exclusion Criteria:

* cannot attend all study sessions
* actively homicidal and/or suicidal
Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer

RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.

OBJECTIVES:

Primary

* To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status.

Secondary

* To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response.

OUTLINE: This is a multicenter study.

Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Participation in CALGB-C80405

  * Have KRAS WT or KRAS mut tumor
  * Randomized to treatment with either bevacizumab or cetuximab alone

    * Patients randomized to the combination therapy are not eligible
* Available specimens at the PCO for BRAF mutation detection
* Patient consent for use of samples
Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients

Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 18 years old
* Intubation over 24 hrs
* Match weaning profile
* Cuff leak volume less than 24%
* VS and subject/family agree

Exclusion Criteria:

* Re-Intubation
* History of upper air way obstruction
* Severe CV disease (ex. AMI)
* Active UGI Bleeding
* Blood sugar persistent more than 250 mg/dl under medication control
* Risk of IICP
* Open T.B.
* Bleeding tendency/ Platelet less than 40 thousands
* Subject or family refuse
Acupoint Stimulation and Postoperative Sleep

Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.

Sleep is a necessary, naturally occurring physiologic state that is especially critical to cognition and physical functioning in surgical settings.Poor postoperative sleep is associated with many significant deleterious effects. Therefore, improving overall sleep during postoperative rehabilitation is desirable.

Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive acupuncture therapy combining the transcutaneous electrical nerve stimulation, and has been utilized in clinical settings for many years. Previous study demonstrated that TEAS combined with anesthesia can upregulate the levels of melatonin and aminobutyric acid to relief central inhibition, thus improve patients'sleep efficiency, prolong total sleep time (TST) and promote sleep quality.

The current study is to examine the effect of perioperative TEAS on subjective and objective sleep quality among patients who have undergone Gynecological laparoscopic surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria

1. Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia
2. Patients aged 18-65 years
3. Patients with a body mass index (BMI) at 18-30kg/m2
4. Patients with American Society of Anesthesiologists (ASA) grades I-III
5. Patients who provide written informed consent

Exclusion Criteria

1. Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
2. Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3));
3. Participants with central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.
4. Participants with contraindications to the use of electroacupuncture (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices).
5. Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease
6. Participants with a history of alcohol or drug abuse. Pregnant or lactating women.
Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

Epidermal growth factor receptor inhibitor (EGFRI) therapy for cancer is associated with potentially severe face and trunk skin acneiform rash. Severe or persistent side effects may lead to decreased dose, interruption or discontinuation of EGFRI treatment. Inflammation is believed to play an important role in EGFRI-induced skin toxicity as a number of proinflammatory cytokines induced by EGFRI are released from epidermal cells, resulting in activation and recruitment of immune cells such as neutrophils and lymphocytes, and subsequent development of skin reaction associated with keratinocyte apoptosis. AC-701 has been reported its antibiotic and anti-inflammatory activities in literature, and further demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated with EGFR inhibition. This study is to evaluate the prophylactic efficacy of topical AC-701 in subjects with skin rash associated with EGFRI therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Is between 20 and 80 years of age, inclusive.
2. Patients who are within ±3 days of initiating EGFR inhibitor therapy using afatinib or erlotinib, and have no prior history of using afatinib or erlotinib within 6 months.
3. Has a life expectancy of at least three months.

Exclusion Criteria:

1. Has any active dermatological conditions of the face that may interfere with the diagnosis, assessment, or treatment of face skin rash associated with targeted cancer therapy.
2. Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to Day 1.
3. Patients who have been treated with oral antibiotics that known to exert anti-inflammatory effect (such as doxycycline or minocycline) within 7 days prior to Day 1.
4. Is currently treated with target therapy other than afatinib or erlotinib.
5. Receive prior treatment with any investigational product within 28 days prior to Day 1.
6. Has hypersensitivity or allergy to the study medication.
7. Has any other significant diseases, conditions, or laboratory values which, in the opinion of the investigator, might make participation not in the subject's best interest or confound the interpretation of study results.
Pain Perception Measurement by EEG and NRS

Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG.

To generate the nociceptive stimulus, The investigators will apply cold (Endo-Ice) to a healthy upper incisor tooth #8. Inclusion criteria: Patients between 20 and 60 years old, with healthy teeth, no history of dental alveolar trauma, and no pulp chamber calcification. After the nociceptive stimulus, patients will write their pain perception on paper from 0 to 10, and at the same time, we will record the brain activity with a non-invasive EEG Emotiv. Then, we will correlate both methods.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age: 20-60 years.
* Tooth #8 vital and mature. No history of dentoalveolar trauma.
* Adequate coronal tooth structure.

Exclusion Criteria:

* Chronic periodontitis.
* Vertical root fracture.
* Immature teeth.
* Necrotic teeth.
* Systemic diseases that affect the healing process.
* Non restorable teeth.