cyrilzakka/clinical-trials huggingface dataset:
Combined Application of EBUS and EUS in Lung Cancer

This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
* Potentially operable patients

Exclusion Criteria:

* M1 disease
* Inoperable T4 disease
* Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
* Confirmed supraclavicular lymph node metastasis
* Pancoast tumors
* Medically inoperable patients
* Contraindications for bronchoscopy and esophageal endoscopy
* Drug reaction to lidocaine, midazolam,fentanyl
* Pregnancy
* Ground glass-dominant nodule ( \< 3cm)
Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

The study aimed to investigate the memory preservation and neurocognitive function protection of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin Chinese or Taiwanese.

Brain metastasis is very common, about 30% incidence rate for all patients with a diagnosis of cancer. The rising incidence of brain metastasis is most likely due to recent advances in systemic therapy, and use of magnetic resonance imaging (MRI). The most common primary site is the lung followed by breast. One of the standard treatments is whole brain radiotherapy; it can prolong the decline of neurocognitive function and improve quality of life. However, it can also cause decline in neurocognitive function as a late sequela. Memory impairment is the main cognitive function that affected by radiotherapy, and the neuronal stem cells located at hippocampal subgranular zone are highly sensitive to radiotherapy. There have been large randomized trials confirming that by HA-WBRT, the neurocognitive function decline can be reclaimed. In Taiwan, HA-WBRT is a popular and emerging treatment. However, not much study focused on its effects on neurocognitive function. The study is aimed to objectively investigate the memory preservation and neurocognitive function protection of HA-WBRT in people speaking Mandarin Chinese or Taiwanese by utilizing neurocognitive function test and QoL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain metastases, the brain metastases are located 5mm outside the hippocampus
* Pathologically proven diagnosis of nonhematopoietic malignancy other than germ cell malignancy
* No psychologic disorders
* Radiation Therapy Oncology Group recursive partitioning analysis class I or II
* First or second language: Mandarin Chinese or Taiwanese
* Signed the inform consensus

Exclusion Criteria:

* Less than 20 years old
* Leptomeningeal metastases or hydrocephalus
* Previous radiotherapy to head and neck region
* Creatinine \>1.5mg/dl
* More than 2 extracranial metastases
* Patients who cannot tolerate memory or neurocognitive function test or cannot complete QoL questionnaire
A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either Smilon® or placebo, and will receive the treatment for 8 weeks in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 20-65 years
* Diagnosis of at least one chronic pain syndrome and the diagnosis of concomitant depression according to DSM-IV criteria
* Have a mean weekly pain score of at least 30 mm on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) before study entry

Exclusion Criteria:

* Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
* Known hypersensitivity to Mirtazapine or any of its components
* Subjects who have a clinically significant or unstable medical or psychiatric condition
* Subjects who have received nerve blocks or acupuncture for pain relief
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization-approved drugs will be used at dosage and for conditions approved.

Eligible patients willing to participate will first be tested prior to enrolment for their glucose-6-phosphate dehydrogenase (G6PD) status by the gold standard spectrophotometric analysis. The investigators will exclude from the study any G6PD deficient (or intermediate females) patient. Treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be relocated to a no-transmission city to make sure they are not reinfected during the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be followed monthly for three months after the end of the relocation.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 and older
* Acute (within 10 days), symptomatic (i.e., history of fever), uncomplicated malaria caused solely by Plasmodium vivax (verified by PCR)
* G6PD normal (as determined by quantitative spectrophotometric assay)

Exclusion Criteria:

* Pregnant, planning to become pregnant or lactating women,
* Received antimalarial drugs in the past month,
* Hb \< 8g/dL, \< 1,500 neutrophils/μl, or signs of complicated malaria (e.g., vomiting, convulsions,...),
* History of primaquine, artesunate or artesunate-mefloquine allergy or intolerance,
* PCR-positivity for severe acute respiratory syndrome coronavirus 2.
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312

The purpose of this study is to Evaluation of absorption, metabolism, and excretion of \[14C\]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.
* Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.

Exclusion Criteria:

* Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
* Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.
Evaluation of Stigma Toward Patients With Alopecia Areata, Atopic Dermatitis, Vitiligo, and Psoriasis

Primary objective:

The primary objective is to evaluate in the general population the difference between emotional reactions associated with facial involvement by four major dermatologic diseases: psoriasis, atopic dermatitis, vitiligo, and alopecia areata.

* Compare the social distance and stereotyping by the general population toward individuals with facial involvement by: psoriasis, atopic dermatitis, vitiligo, and alopecia areata.
* Evaluate demographic factors that describe a greater tendency toward stigmatization.

Basic demographic characteristics (Gender, Age, Employment status, Education level) will be recorded for each patient.

Participants will be asked to observe images depicting faces of individuals with atopic dermatitis, alopecia areata, vitiligo, and psoriasis (generated through artificial intelligence systems). They will be asked to select the individual from those shown that generates the most compassion/pity, disgust, blame/disapproval/disdain, and curiosity for them, analyzing the same emotional responses investigated in a study on stigma toward psoriasis patients.

In addition, each participant will be given a 14-question questionnaire on stigma (analyzing social distance and stereotyping) toward one of the four diseases under investigation (psoriasis, atopic dermatitis, vitiligo, or alopecia areata), selected randomly. For each question, responses will be expressed from 1 to 5, on a Likert scale, with lower scores indicating greater stigma. (Total score between 14 and 70)

Eligibility Criteria:
Inclusion Criteria:

* -Patients aged\>18 years, both sexes;
* Signature of written informed consent;

Exclusion Criteria:

* Patients diagnosed with psoriasis, atopic dermatitis, vitiligo or alopecia areata.
* Patients with first-degree relatives with psoriasis, atopic dermatitis, vitiligo or alopecia areata
* Those who for professional or personal reasons have direct knowledge of the diseases in question.
Cohort Study for Patients Using Fuzeon (Enfuvirtide)

The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new antiretroviral combination therapy (ART) are eligible to participate in this observation.

Physicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART.

Observation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary.

Total observation time for each patients is planned for two years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV-Infection
* Planned to switch to a Fuzeon-containing antiretroviral therapy

Exclusion Criteria:

* Inability to understand or sign inform consent
Etiology, Epidemiology and Prognostics of AKI

* To investigate the etiology and epidemiology of acute kidney injury (AKI).
* To find out risk factors associated with the occurence of AKI.
* To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.
* To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

1. To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.
2. To evaluate the association of serum nutritional variables and prognosis of AKI.
3. Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (\<7 days) and late death (\>7 days, \<28 days) patients.
4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.
5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.
6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years and \<= 88 years
* clinically diagnosed with acute kidney injury, according KDIGO criteria.

Exclusion Criteria:

* preexisting chronic kidney failure (defined as an eGFR \<60 ml/min per 1.73 m2)
* post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI
* known acute renal dysfunction
* hospital stays \<24 hours
* malignancy
A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation

The aim of this study is to describe the forced expiratory volume in 1 second (FEV1) decline and natural disease evolution in patients affected by CLAD-BOS after lung transplantation and receiving an immunosuppressive therapy as standard of care.

This is a retrospective, multinational, multicenter chart review study of adult patients with clinically diagnosed CLAD-BOS after lung transplantation. All data will be retrospectively collected from patient records starting from lung transplantation date through last date of available data, and as such, no interventions will be applied as part of this study.

The observational period for each patient will be from lung transplant date until last date of data available or death, whichever occurs earlier and will include the following time periods:

Diagnosis window: 01 January 2013 through most recent data available.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis
2. Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013
3. Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant
4. Patients received at least basic maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to mycophenolate mofetil or azathioprine (or other anti-proliferative agent), and a systemic corticosteroid such as prednisone as third agent for at least 1 month before the index date. As long as the basic maintenance regimen is maintained for the abovementioned period, patients will still be considered eligible for the study even if they are receiving other immunosuppressive agents in addition to the basic maintenance regimen.

Exclusion Criteria:

1. Patients with severe concomitant disease at the time of index date, which according to physician's judgment, can interfere with CLAD-BOS progression and mortality (e.g., malignancies, severe chronic diseases)
2. Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period
3. Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients

The purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).

This study was conducted in two parts. In Part 1, patients were initially randomized (5:2) to receive either ESBA1008 at the lowest dose (Dose A) or LUCENTIS. After Safety Committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of ESBA1008 (Dose B). Safety review and enrollment of patients into the third cohort (Dose C) and fourth cohort (Dose D) was conducted in the same manner. Part 2, the expansion period, consisted of 2 arms. In the first arm patients were randomized to receive ESBA1008 Dose C or LUCENTIS (43:44) . In the second arm, patients were randomized to ESBA1008 Doses A:B:D:Lucentis (5:30:35:9). All enrolled patients (Part 1 and Part 2) were evaluated for safety and efficacy across 13 study visits, including Screening, Randomization, and 11 post- treatment follow-up visits (Day 1 through Month 6).

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
* New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
* Evidence of subretinal fluid or retinal cystic changes with a CSFT of \> 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
* Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previously administered therapy, approved or investigational, for wet AMD in the study eye.
* Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
* Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
* Uncontrolled or advanced glaucoma in the study eye.
* Use of systemic or topical ocular corticosteroids.
* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.
* Abnormal or unsuitable laboratory results at Screening visit.
* Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
* Other protocol-defined exclusion criteria may apply.
Light Treatment to Shift-working Nurses

This project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.

Shift workers frequently experience sleepiness during night shifts, which may have consequences for performance. Sleep duration is often shortened after a night shift. Properly timed bright light treatment is efficient in delaying the circadian rhythm and can enhance alertness, increase performance and prolong sleep after night shifts. There is a lack of studies on light treatment to rotating shift workers. This study is a randomized controlled crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in rotating shift workers with three consecutive night shifts. The aim is to evaluate whether bright light treatment improves adaptation to three consecutive night shifts (reduces sleepiness during night shifts and improves sleep after night shifts), as well as whether such treatment affects re-adaptation to a day-oriented schedule after the night shift period.

Eligibility Criteria:
Inclusion Criteria:

* A rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts
* Problems with sleepiness during night shifts

Exclusion Criteria:

* Pregnancy
Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.

OBJECTIVES:

* To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
* To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (\> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
* Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
* Survival ≥ 12 months
* WHO performance status 0-2
* white blood cell ≥ 3.5 ×10\*9/L
* Platelets ≥ 5×10\*9/L
* Hemoglobin ≥ 10 g/dL

Exclusion Criteria:

* History of malignant disease
* History of coronary artery disease
* Uncontrolled infection
* Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
* Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with progressive hemifacial atrophy.

Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :18-75, males and females.
* Patients with symptom of hemifacial atrophy but not progress disease.

Exclusion Criteria:

* Patients with currently progressive hemifacial atrophy.
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Subjects who don't understand purpose and method for this study.
* Patients with psychical disorder or drug and alcohol addiction.
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria