cyrilzakka/clinical-trials huggingface dataset:
The Retroclavicular Approach for Regional Anesthesia

The goal of this study is to demonstrate that the novel retroclavicular approach is a safe, fast and effective technique for ultrasound-guided brachial plexus anesthesia.

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Elective or Urgent Surgery of the hand, wrist or forearm
* 18 years and older
* Ability to consent
* American Society of Anesthesiologists class 1 to 3

Exclusion Criteria:

* Infection at the site of infection
* Abnormal anatomy at the site of infection
* Coagulopathy
* Severe Pulmonary Disease
* Preexisting neurological symptom(s) in the operated arm
* Pregnant patients
* Patients weighing less than 50 kg
* Allergy to amide type local anesthetics
The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process

This double-blind randomized controlled clinical trial aimed to investigate the effect of whitening dentifrices on the clinical efficiency of in-office tooth bleaching procedures.

Sixty-three eligible participants (29 males and 34 females, mean age 26.1 years) with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different dentifrices used in this clinical trial: Crest Total (regular dentifrice) for group C, Crest 3D Whitening (conventional whitening dentifrice) for group CW, and Close Up White Now (whitening dentifrice containing blue covarine) for group CU. All participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The participants will be instructed to use only the provided dentifrices and toothbrushes to brush their teeth twice daily over a 4-week period. Colour parameters (CIE L\*, a\*, b\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4), and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and whiteness index (W) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 60 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa ̈ ckingen, Germany) ordered by brightness

Exclusion Criteria:

* patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.
Long Term Study With B2036-PEG

Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

Exclusion Criteria:

* Switching to other therapeutic methods for acromegaly
Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women

The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Major Depressive Disorder (MDD) has been associated with morphological changes in the brain and changes in key brain areas. Studies have shown that antidepressant use may promote the normalization of these areas. Moreover, midlife men and women appear to be at greater risk for developing major depressive episodes. In women, this period of life has been associated with significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. Desvenlafaxine succinate (DVS) has been developed for the treatment of MDD. To date, the effects of DVS on brain structure and functioning in midlife men and women with MDD, as well as on depression related to menopause, has not been explored. The present study aims to investigate the effects of DVS on brain structure and functioning when used for the treatment of a major depressive episode in midlife men and women, using MRI and functional MRI. In addition, the investigators will examine whether the impact of treatment with DVS on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.

Eligibility Criteria:
Inclusion Criteria:

* men and women, aged 40-60 years
* diagnosis of MDD
* for women, perimenopausal or postmenopausal

Exclusion Criteria:

* other DSM-IV axis I diagnosis other than MDD
* using psychotropic medications
* suicidal ideation, homicidal ideation, or psychotic symptoms
* presence of laboratory abnormalities at baseline visit
* presence of heart disease, liver disease, kidney disease, pulmonary disease, blood or bleeding disease, thyroid disease, GI disease, seizure or epilepsy, head injury, cancer, uterine fibroids or endometriosis, gynecologic surgeries (except caesarian sections), electroconvulsive therapies in the past 3 months, HIV+/AIDS
* in addition (for women): use of hormone replacement therapies, menstrual dysfunction, pregnancy or breastfeeding
Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

In our study, changes in vastus lateralis muscle oxygenation will be evaluated with the Moxy device, a functional infrared oxygen measurement device, during the inspiratory muscle fatigue protocol in COPD cases and the healthy control group.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Stage 2-3 COPD according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
* Having been using the same medications for the last 4 weeks

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\\min).
* Presence of any vascular problem that may affect lower extremity muscle oxygenation
* Presence of another respiratory system disease other than COPD
* Patients who have had an acute COPD exacerbation in the last 4 weeks
* Patients experiencing COPD exacerbations during the study protocol
* Presence of fatty tissue or scar tissue at the measurement points, which may impair the measurement quality.
* Have already participated in another clinical trial within the last 30 days that may affect the results of the study.

Inclusion Criteria for Healthy Cases

* Being over 18 years of age
* Not having any diagnosed chronic disease
* Not being a smoker
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.

The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).

Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.

Eligibility Criteria:
Inclusion Criteria:

1. Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
2. Research subjects were male, aged between 18 and 32 years;
3. Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
4. Considered healthy subjects, both clinical and laboratory.

Exclusion Criteria:

1. Have donated or lost 450 mL or more blood in the 6 months preceding the study;
2. Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
3. Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
4. Present history of alcohol abuse, drug or drugs;
5. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
6. Have made previous use of somatropin;
7. Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).
The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women

As intrauterine contraception is an increasingly popular form of contraception the objective of our study is to examine if uterine size or posture affects the insertion or use of intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.

Prospective observational study among nulliparous women requesting intrauterine contraception.

Eligibility Criteria:
Inclusion Criteria:

- nulliparous women with no previous history of IUD use

Exclusion Criteria:

* malformation of uterus
* myomas
* acute gynecological infection
* malignant uterine or cervical tumor

In addition if requesting a Cu-IUD

* heavy menstruations
* iron deficiency
* bleeding disorder
* copper allergy or Wilson's disease
Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

The purpose of this study is to determine that six 2-mg tablets of perampanel are bioequivalent to one 12-mg tablet of perampanel.


Eligibility Criteria:
Inclusion:

1. Healthy male or female subjects, age 18 to 55 years old, inclusive, at Screening
2. Body mass index (BMI) of 18 to 32 kg/m\^2, inclusive, at Screening

Exclusion:

1. Subjects who are taking any prescribed or over-the-counter drug or herbal remedies in the 2 weeks prior to Screening (unless the OTC drug has a long halflife \[i.e., 5 x 1/2 greater than 2 weeks\]) with the exception of acetaminophen (up to 4 g/day), which is allowed up to 12 hours prior to dosing
2. Subjects who have taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
3. Subjects who have taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, apple or Seville orange products)
4. Subjects who have received any experimental drug within the 12 weeks leading up to the start of study drug treatment or who are currently enrolled in another clinical trial
5. Subjects with a known or suspected history of alcohol abuse within the 6 months prior to Screening or who have a positive urine drug test or breath alcohol test at Screening or Baseline, or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement
6. Subjects who consume more than 5 caffeinated beverages per day (e.g., 5 cups of tea, coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the periods of in-patient confinement
7. Subjects who smoke more than 5 cigarettes (or equivalent amount of tobacco) per day or who are unwilling to abstain from the use of nicotine-containing products throughout the period of in-patient confinement
8. Subjects who have a history of drug abuse or dependence or have a positive result from a urine drug screening test
9. Women of child-bearing potential who do not agree to use 2 methods of adequate contraception (e.g., intrauterine device, barrier methods with spermicide) throughout the study and for 30 days after study drug administration
Native T1 Mapping by Cardiovascular Magnetic Resonance Imaging in Rare Diseases

Fabry Disease (FD) is a rare, X-linked lysosomal storage disorder leading to left ventricular hypertrophy, myocardial fibrosis, arrhythmia and heart failure. Cardiac involvement is the leading cause of death in FD. Treatment with enzyme replacement therapy is expensive, may be poorly targeted and there are difficulties in early detection and disease monitoring. T1 mapping signal change is a potential remarkable biomarker for FD.

Fabry400 is a multicentre study aiming to understand the biology of Fabry Disease and its relationship to non-invasive multi parametric mapping by CMR.

Our understanding of cardiac involvement in FD is limited because the myocyte storage cannot be assessed non-invasively. However with the development of CMR T1 mapping this maybe possible. T1 mapping demonstrated excellent discrimination between FD and other causes of LVH, and this property is highly suggestive of a direct but intricate relationship between T1 signals and abnormal fat storage. Specifically, 50% of patients without LVH have low T1 values, suggesting that T1 is an early disease marker in FD. This property may prove particularly useful for assessing disease progression and treatment response in early disease.

In CMR, LGE in FD characteristically occurs in the basal inferolateral wall. LGE is associated with a poor response to therapy and adverse outcomes. Hybrid imaging with PET/MR has shown that some FD LGE may be inflammation. T2 mapping may be useful as it is a sensitive detector of inflammation and oedema, for example discriminating acute from chronic myocardial infarction, and diagnosing myocarditis, particularly in the setting of chronic myocarditis or heart failure.

The aims of this study are:

1. Improve the diagnosis of cardiac involvement by recognition of early disease
2. Detect early changes and responses to therapy
3. Improve the understanding of the pathophysiology of cardiac involvement using multiparametric mapping by CMR

Study Method:

This is a cohort observational study of FD patients including children, patients starting ERT, ERT naïve patients and LVH positive patients. Follow up scans at 6 months and 12 months will be done on patients starting ERT. CMR Scanning will use T1 and T2 mapping techniques against established gold-standard sequences. The patients will also have ECHO and ECG. Blood biomarkers will be collected (serum, plasma and urine).

Eligibility Criteria:
Inclusion Criteria:

* Gene-positive Fabry Disease
* Male or female
* Age at least 9 years

Exclusion Criteria:

* Any absolute contraindication to CMR
* Pregnancy
MFOLFIRINOX with or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 19 years or greater
* Cytologically or histologically confirmed pancreatic adenocarcinoma
* Locally advanced unresectable disease per National Comprehensive Cancer Network resectability criteria
* No active infection except chronic hepatitis on anti-viral therapy
* Eastern Cooperative Oncology Group performance status 0 or 1
* Body weight \> 30 kg
* Normal organ and bone marrow function

Exclusion Criteria:

* Gastrointestinal obstruction
* Active gastrointestinal bleeding or ulcer
* Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization
* Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors)
* Pregnancy or breastfeeding
Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

Secondary

* To determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen.
* To determine the survival time of patients treated with this regimen.
* To determine the time spent in a Karnofsky performance status of 60-100%.

OUTLINE: This is a dose-escalation study of temozolomide.

Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks.

After completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
* Age \> 18 years
* Given written consent
* Adequate bone marrow reserve(hemoglobin \> 10 grams, Absolute neutrophil count \> 1500 / mm3, platelets \> 100,000/ mm3)
* Normal renal function(BUN \< 24 mg/dL, Creatinine \< 1.3 mg/dL)
* Normal liver function(Total Bilirubin \< 1.5 mg/dL, SGPT/ALT \< 60 U/L)

Exclusion Criteria:

* Have a Karnofsky score of \< 60 \[Appendix B\] or age \< 18 years.
* Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
* Tumors located in the brainstem or optic chiasm.
* Prior radiation therapy to the brain
* Prior chemotherapy within the past 6 weeks.
Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions

Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial. Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement. Investigators assess whether Natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. When this study is completed, it will increase the value of Natureheme-iron, and can improve health of Taiwanese.

FAO / WHO noted that iron deficiency is still an important nutritional problem. Iron deficiency problem has always been in Taiwan. This study intends to use the products, Natureheme-iron, using blood of pig to concentration, separation and extracted, and then got natural and clean Natureheme-iron. Natureheme-iron is not just a good iron supplement, while also providing an excellent source of natural protein. This is a randomized, double-blind trial, subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for a total of 12 weeks (1000mg Fe / capsule), another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement (100mg Fe). Investigators assess whether Natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. When this study is completed, it will increase the value of Natureheme-iron, and can improve health of Taiwanese.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were anemia men or women aged over 20 years old with Hb\<=12 g/dl.

Exclusion Criteria:

* Subjects were excluded if subjects had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. Subjects were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.
The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases

The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.

The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.


Eligibility Criteria:
Inclusion Criteria:

* Age 18y or older
* patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease
* Patients with CHF
* Patients with pulmonary hypertension
* Patients with COPD
* Patients with Asthma
* Signed informed consent
* Normal subjects

Exclusion Criteria:

* Patients with unstable conditions: unstable angina, uncontrolled CHF, etc
* Inability to assume a sitting or supine position
* Patients with severe chest wall deformity