cyrilzakka/clinical-trials huggingface dataset:
Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \& better long-term stability \& less relapse rate.

Maxillary distraction using rigid external distraction device (RED) with skeletal anchorage in cleft lip and palate overcomes the disadvantages of tooth brone RED \& showed reliable advancement \& reasonable relapse rate in the short \& long-term follow up \& most importantly it solved somehow counterclockwise rotation of maxilla but still it can occur. Positioning of plates in relation to center of resistance of maxilla to adjust vector of distraction can be done now by using Virtual surgical planning (VSP) \& fabrication of patient specific implants (PSI) to overcome problems encountered with use of conventional miniplates during distraction process. Limited data in literature with no randomized clinical trials were done to assess distraction effectiveness using PSI in RED with skeletal anchorage and its effect on velopharyngeal insufficiency (VPI) \& speech. Based on that data, the research will compare distraction effectiveness, VPI \& speech between using either PSI implants or miniplates for distraction.

Eligibility Criteria:
Inclusion Criteria:

1. Non growing cleft patients, age range (18-30 years)
2. Unilateral or bilateral cleft patients
3. Anteroposterior deficiency (1.5-2.5 cm)
4. No sex predilection

Exclusion Criteria:

1. Syndromic patients.
2. bone metabolism \& systemic diseases.
The Effect of Acupressure Applied Before Suturing Procedure in the Emergency Department on Anxiety and Vital Signs

This study suggests that the anxiety experienced by patients during suturing in the emergency department can be reduced with acupressure and offers a research proposal on vital signs.

Problem: During suturing in the emergency department, patients experience high levels of anxiety due to the pain they experience and fear of the procedure. This situation complicates the treatment process, negatively affects the health of patients and creates a difficult situation for healthcare professionals.

Solution Suggestion: Acupressure can be used as a non-invasive, safe and effective method to reduce patients\&#39; anxiety. Acupressure reduces pain, provides relaxation and reduces anxiety by increasing the secretion of endorphins in the body.

Purpose of the Study: The purpose of this study is to evaluate the effects of applying acupressure to patients before suturing in the emergency department on their anxiety levels and vital signs (such as blood pressure, heart rate).

In summary, this research has a significant potential that emergency room nurses can improve patients\&#39; quality of life and make treatment processes more effective by using acupressure in patient care.

Key Words: Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department


Eligibility Criteria:
Inclusion Criteria:

* Suturing is done with local anesthesia,
* Those who are 18 years or older,
* Conscious, oriented and cooperative,
* Able to read and understand Turkish,
* Agreeing to participate in the study,
* Anxiety not diagnosed,
* Not using medication for anxiety,
* No acupressure experience,
* No physical problems that would prevent acupressure application to Ht7 and Li4 points,
* Not pregnant,
* Patients who sign the \&#34;Voluntary Informed Consent Form\&#34; will be included.

Exclusion Criteria:

* Those who are under 18 years of age,
* Unconscious, unoriented and uncooperative,
* Cannot read and understand Turkish,
* Those who do not agree to participate in the study,
* -Diagnosed with anxiety,
* -Using medication for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
* Having previous acupressure experience,
* Having a physical problem that prevents the application of acupressure to Ht7 and Li4 points,
* Pregnant,
* Patients who do not sign the \&#34;Voluntary Informed Consent Form\&#34; will not be included.
Inspiratory Muscle Training and Hospital Complications

The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. It is generally agreed the positive impact of the application of a TMI Protocol on maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the muscle; the specificity of training; the reversibility of the gain and muscle atrophy.

This prospective double-blind (patient and evaluator) randomised controlled trial compared the efficacy of inspiratory muscle training and inspiratory muscle training. The study protocol for this trial was described elsewhere. This study was conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial was performed at the Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 03/2014). Before enrolment, written informed consent was obtained from participants or their legal guardians.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the hospital ward;
* At least two of the following risk factors for prolonged hospitalization: two or more comorbidities; sepsis; liver, lung, or kidney diseases; neoplasia; mechanical ventilation; and use of vasopressor or dialysis therapy.

Exclusion Criteria:

* Patients with a cognitive disability that made them unable to perform the respiratory training;
* Uncontrolled cardiac arrhythmias;
* Circulatory shock;
* Acute ischemic heart disease;
* acute respiratory failure (characterised by a partial pressure of arterial oxygen \< 60 mmHg or a partial pressure of arterial carbon dioxide \> 50 mmHg);
* neuromuscular disease or myopathies;
* diaphragmatic paresis or paralysis were excluded from the protocol.
Non-specific Back Pain and Spinal Manipulation

The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors.

The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated at baseline and at 7 days. Pain score will be also assessed every day with text-tracking. Global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors. 100 individuals with a history of non-specific back pain will be recruited in a chiropractic care center.

Eligibility Criteria:
Inclusion Criteria:

* Being aged over 18 years old
* Presenting non-specific back pain (chronic \>=3 months or recurrent complaint)
* Speaking French or English

Exclusion Criteria:

* Symptomatic thoracic pain
* Non-musculoskeletal disorders pain
* Pregnancy
* Not eligible to spinal manipulation (if osteoporosis, vertebral fracture history, thoracic disk herniation)
The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes

A person's life is a stage that passes in the time interval that ends with his birth when he opens his eyes to the world and his death when he closes his eyes to the world. Old age is a forced end for all people. Sleep is one of the most important and basic human needs. It prepares the individual for a new day by resting the body, strengthening and regulating the cerebral functions and repairing the brain. While a change in sleep pattern and quality affects a person's daily life activities, long-term persistence of this change may lead to deterioration of body and mental health.During Reiki practices, the hands are held in each position for 3-5 minutes by touching the head, neck, chest, abdominal cavity and groin. In problem areas, this time can be extended to 10-20 minutes. The duration of treatment lasts an average of 30-90 minutes. During the application, the person is in a lying or lying position and does not need to take off his clothes.

In the elderly, the pathology of fatigue has not yet been fully elucidated. Natural changes and the disadvantages of age can be the cause of fatigue. Decrease in muscle strength, sarcopenia, pain, inactivity, changes in body composition due to malnutrition, decrease in physical fitness, insufficient energy systems, cardiovascular and respiratory problems, medications used can cause fatigue in the elderly. It has been shown that 27-50% of the elderly suffer from moderate to severe fatigue. Increasing the severity of fatigue reduces the daily activity performance of the elderly (6). Today, in many areas, in addition to medical treatment to reduce the symptoms of chronic diseases, alternative and complementary medicine are also used. Reiki, which constitutes our research subject; one of the energy approaches, in Japan at the end of the 19th century, Dr. It is a complementary medicine application discovered by Usui in Sanskrit inscriptions, which has been shown to be effective on pain, depression, insomnia and fatigue symptoms. Reiki is generally safe and no serious side effects have been reported. Reiki practice in the last 10 years; it increases among physicians, nurses and other health workers.

Eligibility Criteria:
Inclusion Criteria:

* • Being a nursing home resident and being 50 years or older,

  * Not having a communication problem,
  * Not having been diagnosed with bipolar disorder, schizophrenia or other mental illness,
  * Not taking antidepressant treatment,
  * Having chronic pain (arthralgia, back pain, musculoskeletal pain - at least once a day),
  * Not using a pain reliever all the time,
  * Willingness to participate in a four-week reiki program,
  * Not having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months.
  * Having a scale score of \>5 on the Piper Fatigue Scale
  * A score of \>5 on the Pittsburgh Sleep Quality Scale
  * A scale score of \>5 on the Visual Analog Scale

Exclusion Criteria:

* Needing antidepressant treatment,
* Not getting bored with work and not wanting to answer questions.

Exclusion Criteria:

-
Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.


Eligibility Criteria:
Inclusion Criteria:

* CKD patients with eGFR\<60 mL/min/1.73 m\^2
* De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
* Signed written informed consent

Exclusion Criteria:

* Onset of STEMI within 24 hours or emergent angiography
* Pregnant or childbearing women
* Co-morbidity with an estimated life expectancy of \< 1 year
* LVEF ≤ 30%
* Cardiogenic shock or hemodynamic instability
* Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
* PCI within the previous 12 months
* Target lesion of stent thrombosis or in-stent restenosis
* Any planned non-cardiac surgery within 12 months
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
* Current enrolment in other clinical trials
* Contraindication to anti-platelet agents
* History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
* Chronic total occlusion lesion with unsuccessful guidewire crossing
* Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
* Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)
* Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days
* Intake of anticoagulants
* Hemoglobin \<60 g/L
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
* Patients allergic to metals or contrast
Endotoxin and Bronchial Inflammation in Asthma

To evaluate airway inflammation in persons with asthma exposed to endotoxin, a common occupational air contaminant. Subjects are subsequently challenged with allergen.

BACKGROUND:

Endotoxin (or lipopolysaccharide \[LPS\]) is a potent inflammatory stimulant which is found in ambient air in occupational settings. Asthma in the workplace is an increasingly significant problem. Asthma is characterized by airway inflammation and increased reactivity to both allergic and non-allergic stimuli. LPS is known to induced airway inflammation in normal subjects and to enhance airway reactivity in asthmatics. Additionally, both alveolar macrophages and mononuclear cells from asthmatics secrete higher amounts of cytokines (interleukins 1 and 8 \[IL-1, IL-8\] and granulocyte macrophage-colony stimulating factor \[GM-CSF\] ) than those from normals. Thus, it is likely that LPS enhances allergen-induced inflammation and that allergic asthmatics are more sensitive to the effects of LPS. Preliminary data show that exposure to low levels (250 ng/m3) of LPS at risk for four hours enhances both immediate responsiveness to inhaled allergen and allergen-induced eosinophils as observed in induced sputum. In the nasal airways of allergics, a single dose of 1,000 nanograms of LPS enhances polymorphonuclear leukocyte influx associated with allergen challenge. This latter finding also correlates well with baseline IL-8 and ECP levels, suggesting that constitutive airway inflammation enhances response to these stimuli.

DESIGN NARRATIVE:

The effect of endotoxin LPS (5,000 nanograms) is compared on airway inflammation and methacholine response and lung function in normals and asthmatics; the effect of LPS (500 nanograms) is compared on allergen-induced reactivity and inflammatory cell influx following LPS exposure (5,000 nanograms) in asthmatics, likely as a result of decreasing baseline inflammation. To examine potential cellular mediation of the effect of LPS in asthma, cytokine secretion of mononuclear cells to LPS of subjects responding to LPS (or those in whom LPS enhance response to allergen) is compared to those who did not respond. In vitro monocyte and in vivo airway responses of asthmatics who are responsive and non-responsive is compared to baseline sputum and nasal lavage fluid IL-8 and ECP to determine if either in vitro monocyte responses or IL-8 and ECP in readily obtained airway fluids may serve as biomarkers of LPS responsiveness and might be used as a marker for a LPS-response phenotype in humans for future mechanistic and intervention studies. Finally, practical data on the effect of LPS in asthmatics (at levels found in typical work settings) and the ability of standard anti-inflammatory therapy to protect asthmatic workers unavoidable exposed to LPS will be obtained.

The study was renewed in 2001 and continues through December, 2005.

Eligibility Criteria:
No eligibility criteria
The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo

Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Diagnosed with Sleep Apnea
* DHI score equals or over 16 points

Exclusion Criteria:

* Pregnant women
* Patients diagnosed with mental diseases
* Patients taking anti-vertigo medications
* Patients after CVA or with peripheral neuropathy
* Patients who suffered severe head trauma
* Patients with chronic renal failure
* Patients with malignancy at the time of the study
Metformin Prostate Cancer Adjuvant Trial

This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.

Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male \> 18 years of age
* Biopsy confirmed adenocarcinoma of the prostate
* Able to swallow and retain oral medication
* Hemoglobin A1C \<7.0%
* Able and willing to participate in the full 12 months of the study
* Able to understand instructions related to study procedures
* Able to read and write English

Exclusion Criteria:

* Metastatic Prostate Cancer
* Prostate Specific Antigen Doubling Time \< 6 months
* Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
* Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
* Diagnosis of Type 1 Diabetes Mellitus
* Known hypersensitivity to metformin
* any condition associated with increased risk of metformin associated lactic acidosis
* participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
* any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
* history of megaloblastic anemia
* abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
* history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
* history or current evidence of substance abuse within 12 months of screening
* history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject
Role of Early Versus Late Switch to Lapatinib-Capecitabine

The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Eligibility Criteria:
* Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
* Older than 18 years old;
* Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
* Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
* Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting;
* Signed consent to participate and release information for this study.
A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters

The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are:

* Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care?
* Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters?

Researchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months.

Participants will:

* Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan.
* Be randomly assigned to either the intervention group (HLS App) or the control group (usual care).
* Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention.

Anticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Career firefighters who are older than or equal 20 years old

Exclusion Criteria:

* Career firefighters who are younger than 20 years old
* Firefighters who are retired or are volunteer firefighters.