cyrilzakka/clinical-trials huggingface dataset:
Laser Spectroscopy of Breast Tissue Through a Needle Device

RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.

OBJECTIVES:

* To prove that optical spectra collected by inserting an optical fiber probe into breast tissue through a biopsy needle can be of adequate quality to render a spectroscopic diagnosis.

OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.

Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Discarded normal and malignant breast tissue surgical specimens from women who have undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction surgery at the University Hospitals-Case Medical Center
* Hormone receptor status unknown

PATIENT CHARACTERISTICS:

* Menopausal status unknown

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers

Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy males
* Participants should be ranging from 21 to 50 years of age
* Body mass index (BMI) within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on in-house trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to pramipexole, or other dopamine agonists
* Supine blood pressure at screening of systolic \< 110 mmHg and diastolic \< 60 mmHg
* A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/mL)
* Subjects involved in passenger transport or operation of dangerous machines
The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit

The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.

Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep.

Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam.

The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* sedation patients with dexmedetomidine or midazolam
* over 18 years old

Exclusion Criteria:

* Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
* Brain infection
* Alcoholics
* Major Depression Disorder, Schizophrenia, Anxiety disorder
* Hearing loss
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)

The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
* FEV1 80 - 105% of predicted
* Healthy with the exception of asthma
* Written informed consent has been obtained
* Outpatients
* Patients who have a history of persistent bronchial asthma for at least 6 months

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Patient is current smoker with 10 or more pack-years
* Patient is ex-smoker with 10 or more pack-years
The Secret Trail of Moon (Serious Videogame) and Chess on ADHD: a Clinal Trial

Blackground:

Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest. Especially, the use of Virtual Reality video games. Our team has developed an innovative video game based on Virtual Reality, "The Secret Trail of Moon (TSTM) as a cognitive tool to train 5 main areas of deficit in patients with ADHD. It is superiority study comparing TSTM with therapeutic chess and control group.

Methods:

This study is prospective, unicentric, randomized with a control group. 105 patients diagnosed with ADHD and pharmacologically stable, aged between 12 and 22 years. These patients will be randomized intro three groups: TSTM group (The Secret Trail of Moon); TC group (Therapeutic Chess) and CG (Control Group). Objective and subjective measures of the patient, parents and teachers will be included. Patients´visit will be different for each group. The TSTM group will have 15 face-to face visits: pre-inclusion visit, inclusion visit, 12 training visits and final visit. CT and GC group patients will have 3 face-to- face visits (pre-inclusion, initial visit and final visit) and 12 email or phone communications during training.

Discussion: This study aims to demonstrate the added efficacy of cognitive training to drug treatment. It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training (TC) and a control group.

TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique: the feeling of immersion in the scenarios, the variety of mechanics, the personalization and the playful aspect.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults (male and female) between the ages of 12 and 22.
* Diagnosis of Attention Deficit Hyperactivity Disorder.
* Patients with stable pharmacological treatment for ADHD.
* Signature of the informed consent by the patient and their parents.

Exclusion Criteria:

* A diagnosis of ADHD comorbid with autism spectrum disorder or mental retardation.
* Suffering from epilepsy.
* Mobility plans in the next 3 months.
* Plans to begin other psychological treatment, including cognitive-behavioral psychotherapy in the next 3 months.
* Possibility of suicide risk as assessed by the clinician.
North Taiwan Stroke Center for Prevention and Treatment

The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical center, 3-year, multipurpose study. The aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol based on people's awareness of stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three components in rehabilitation projects. First, we want to identify potential factors related to functional outcome in patients with stroke before and after stroke center. Second, we want to compare the functional outcome in patients who admit to the stroke center as to those admitted to the general ward. Third, we want to investigate the effect of electrical stimulation on upper limb function in patient with acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* acute stroke
* age \> 18 y/o
* consult rehabilitation
* client or agent can sign a letter of consent

Exclusion Criteria(for rehabilitation protocol):

* contraindication of electrical stimulation(pacemaker implant, severe arrhythmia, malignant cancer, wound on stimulation site)
High-Intensity Aerobic Interval Training in Testicular Cancer Survivors

This study evaluates the impact of a supervised 12-week high-intensity aerobic interval exercise program (versus a self-directed exercise usual care group) on traditional and novel cardiovascular disease risk factors and surrogate markers of cardiovascular- and overall-mortality in a population-based sample of testicular cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed history of testicular cancer

Exclusion Criteria:

* Not sufficiently ambulatory to complete the first two stages of the aerobic exercise test.
* Have a psychiatric condition which impairs their ability to perform the required volume and intensity of exercise.
* Have any uncontrolled cardiovascular condition (i.e. heart disease, hypertension, diabetes, arrhythmia).
* Report performing any weekly vigorous intensity aerobic exercise in the past month.
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.


Eligibility Criteria:
Inclusion criteria:

* presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
* must have been taking MTX for at least 3 months before randomization and must currently be on a stable dose of MTX for at least 4 weeks before randomization.
* At Baseline: Disease activity criteria defined by \>6 tender joints out of 68 and \>6 swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28

Exclusion criteria:

* RA patients functional status class IV according to the ACR 1991 revised criteria
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
* Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
* Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
* Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization
* Other protocol-defined inclusion/exclusion criteria may apply.
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* Has SLE by American College of Rheumatology revised criteria (meets \>/= 4 criteria)
* Has had SLE for at least 6 months prior to study entry
* Has at least one elevated autoantibody level at study entry
* Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)

Exclusion criteria:

* Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
* Allergy to human antibodies or Murine
* Prior therapy with other anti-B cell antibodies
Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study

The temporomandibular joint (TMJ), is the only movable joint between the joints in the head and neck system. It is a component of the chewing system and is involved in important functions such as speech, swallowing, taste and breathing. Temporomandibular dysfunction (TMD) is the general name given to various musculoskeletal problems seen in the stomatognathic system, mostly affecting the masticatory muscles and/or TMJ. TMD is the second most common musculoskeletal pain after chronic low back pain. Patients with TMD may also complain of other musculoskeletal problems, craniocervical problems, sleep problems, and anxiety disorders. The aim of this study is to investigate, compare and examine the relationship between neck dysfunction, headache and temporomandibular dysfunction severity, anxiety and sleep quality in female individuals.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years
* Temporomandibular disorders more than 6 months
* Volunteering

Exclusion Criteria:

* Cranio-cervical trauma and temporomandibular operation history
* Infection
* 20-40 points from Fonseca Anamnestic Index 20-40 points
Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients

The purpose of this study is to estimate the cost-utility of continuous positive airway pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil, after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of medical visits, hospitalizations, medical examinations, used medications, new case incidence and cost of traffic accidents and absence from work. It is also designed to estimate quality-adjusted extended years of life, and to assess cost-effects of the therapy (device, masks, supplies, maintenance/year for membership of professional consulting, electric power) on the cost-effectiveness

OSA is highly prevalent in Sao Paulo city, Brazil. It is associated with significant comorbidities. The cost-utility study is important to (1) support decision-making on health policies, (2) to incorporate new technologies, (3) implementation of preventive programs and policy development assistance in the medical field.

Probably CPAP treatment in the long-term, will improve health, physical and mental state, and especially, reduces spending on public health, demonstrating cost-utility.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Aged 30 to 70 years old
* AHI \> 30 events/hour

Exclusion Criteria:

* Patients residing in other cities and states other than São Paulo / SP / Brazil
* Patients with no fixed residence
* Previous CPAP contact
Home Operations Utilizing Stimulation

This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.

The vagal nerve is a major component of the autonomic nervous system and mediates the physiological responses of major organs during moments of stress and learning, including brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been indicated to improve stress response and to enhance neuroplasticity by directly impacting brain structures critical for cognition. Historically, VNS methods required neurosurgery and were reserved for medically intractable epilepsy or other severe conditions. Today, vagal nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will utilize a home-operated stimulator in healthy young adult and healthy older populations to provide a proof of concept of practical home-use stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
* Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

Exclusion Criteria:

* Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
* Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.
Randomized Controlled Trial of Full-Arch Rehabilitation

This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous patients with an adequate area: at least two teeth in the posterior area
* Age over 18 years
* Adequate width of the bone crest without the need for bone regeneration
* Consensus to participate in a oral hygiene maintenance program
* Consensus to participate in a long-term study
* Availability to provide their free and informed consensus.

Exclusion Criteria:

* Systemic diseases that preclude participation in the study
* History of radiation therapy
* Bone lesions
* Cigarette smoking (more than 10 cigarettes per day)
* Inadequate oral hygiene
* Untreated periodontitis affecting residual teeth
Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.

Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects are not limited by gender, age from 18 to 75 years old;
2. Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
3. Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
4. ECOG score 0-1;
5. without distant metastasis;
6. received induction chemotherapy plus immunotherapy, followed by surgery
7. The expected survival is expected to be no less than 6 months.
8. No contraindications to chemotherapy, immunotherapy, and radiotherapy;

Exclusion Criteria:

1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
2. Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
3. Previously experienced head and neck radiation therapy;
4. Subjects who have used corticosteroids (\>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
5. Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;
6. Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes