cyrilzakka/clinical-trials huggingface dataset:
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Patients can be included if ALL the following criteria are met:

  1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
* Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
* Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language

Exclusion Criteria:

* Patients should not be included if ANY of the following criteria is met:

  1. Lung transplantation expected within next 6 months.
  2. Inclusion in ongoing clinical trials.
Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery

Ventilator mode change was associated with decrease in blood loss during posterior lumbar interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose of this study was to determine the effect of equal ratio ventilation (ERV), which sets the I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due to decrease in the PIP.

After anesthesia, patients will receive ventilator settings according to theri group. The CVP will be measured before and after the prone position to ensure the proper positioning. Airway pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index. Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will be recorded 72 hrs after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age : 20\~75 yr-old 2) Surgery : Posterior lumbar interbody fusion(PLIF) 2\~3 levels

Exclusion Criteria:

* 1) Urgent or Emergency case 2) Previous lnstrumentation of lumbar spine (Exclusion : Discectomy, Partial hemilaminiectomy, etc) 3) Concurrent other operation 4) Patients who cannot understand informed consent (ex. Illiterate, Foreigner) 5) Obesity (BIM\>30kg/m2) 6) Recent myocardial infarction (within 3 months) 7) Reduced left and right ventricular function (Ejection fraction\<40%) or Congestive heart failure 8) Preoperative dysrhythmia 9) Aspirin or Plavix during perioperative periods 10) Lung disease 11) Chronic kidney disease or Dialysis 12) Severe hepatic disease
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.

The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Acute exacerbation of COPD type I or II according to GOLD
* Ability to perform lung function tests
* Ability to take oral medication

Exclusion Criteria:

* Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
* Pretreatment ( \> 24 hours) with an antibiotic for the present exacerbation.
* Pretreatment with corticosteroids (\>30 mg for more than 4 days) for the present exacerbation.
* Progression or new radiographic abnormalities on the chest X-ray.
* Severe exacerbation that required mechanical ventilation.
* History of bronchiectasis
* Recent or unresolved lung malignancy.
* Other disease likely to require antibiotic therapy.
* Significant gastrointestinal or other conditions that may affect study drug absorption.
* Class III or IV congestive heart failure or stroke.
* Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (\>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
* Cystic fibrosis
* Tuberculosis.
* Impaired renal function (creatinine clearance \< 20 ml/min).
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must be 22 years of age or older
* Able to comprehend and provide written informed consent
* Willing and able to comply with schedule for follow-up visits
* Demonstrate sufficient cognitive awareness to comply with examination procedures
* Other inclusion criteria specified in the protocol may apply.

Key Exclusion Criteria:

* Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
* Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
* Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
* Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
* Other exclusion criteria specified in the protocol may apply.
The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

This is a single center study that uses both between-group comparisons and correlational analyses to establish biomarkers of dysmyelination and cognitive impairment in Psychotic Spectrum Disorders using imaging and neuropsychological assays.The study will provide non-invasive biomarkers of cognitive dysfunction in Psychotic Spectrum Disorder.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* current DSM-5-defined diagnosis of a schizophrenia or bipolar disorder. A best estimate diagnostic approach will be utilized in which information from the Diagnostic Interview for Genetic Studies (DIGS) is supplemented by information from family informants, psychiatrists, and medical records to generate a diagnosis as needed
* no alcohol or substance abuse during the last 6 month
* no current substance-induced psychotic disorder or a psychotic disorder due to a general medical condition determined by DSM-5 criteria
* ages 18 to 30 years old;
* any race
* competent and willing to sign informed consent
* within 5 years from the disease onset.

Siblings:

* have the same biological parents as their PSD sibling
* any race
* no current or past history of psychotropic medication usage
* no alcohol or substance abuse during the last 6 months
* competent and willing to sign informed consent;
* ages 18 to 30 years old.

Healthy controls:

* matched for age to PSD patients
* no current or past history of psychotropic medication usage
* no prodromal symptoms and no family history of PSD
* no alcohol or substance abuse during the last 6 months
* competent and willing to sign informed consent.
* all attempts will be made to recruit controls with similar parental SES as patients. However, given that PSD are both a neurodevelopmental and familial disorder, exact matching for educational level or IQ may neither be possible nor desirable.

have the same biological parents as their PSD sibling

* any race
* no current or past history of psychotropic medication usage
* no alcohol or substance abuse during the last 6 months
* competent and willing to sign informed consent;
* ages 18 to 30 years old.

Exclusion Criteria:

* a serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain, 2) organic brain disorder, mental retardation, or significant medical illness;
* significant risk of suicidal or homicidal behavior;
* must not have met DSM-5 criteria for current alcohol or drug dependence in the last 6 months;
* contraindications to MRI scanning (i.e., metal implants, pacemakers, pregnancy, etc.);
* documented loss of consciousness (LOC) for longer than 30 minutes or LOC with any neurological sequelae.
Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

The objectives of this study are to:

1. Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality
2. Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module

Eligibility Criteria:
Inclusion Criteria:

* All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
* Age ≥ 22

Subjects with Normal Eyes:

* Corrected visual acuity ≥ 20/40 in each eye

Subjects with Pathology:

* Subjects with vascular retinal conditions in at least one eye
* Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Exclusion Criteria:

* All Subjects:
* Subjects unable to read or write
* Subjects with ocular media not sufficiently clear to obtain acceptable study- related imaging
* Subjects who cannot tolerate the imaging procedures
* Subjects with contraindication to pupillary dilation in the study eye
* Subjects with Normal Eyes:
* Subjects with uncontrolled systemic conditions, or ocular disease, as determined by the Investigator, during the eye exam and CFP
* History of ocular surgical intervention (except for refractive or cataract surgery) in either eye
Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients

The goal of this study is to evaluate the metabolic effects of concomitant use of three consecutive doses of recombinant human growth hormone over three days and exercise during continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate the metabolic effects of nutritional supplementation alone without the additional anabolic strategies.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis for more than 6 months, on a thrice weekly hemodialysis program;
* Adequately dialyzed (Kt/V \> 1.4).

Exclusion Criteria:

* Patients unable to perform exercise.
* Pregnant women.
* Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients with recirculation detected on the AV graft.
* Patients receiving steroids and/or other immunosuppressive agents
Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)

* Development of ADRs specified as Key Investigation Items and the risk factors
* Contributing factors possibly having an impact on the safety and efficacy
* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use


Eligibility Criteria:
Inclusion Criteria:

Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.

Exclusion Criteria:

N/A
Clinical Outcomes of Peroral Endoscopic Myotomy

Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.

Prospective study

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as esophageal outflow obstruction
* Patients with informed consent

Exclusion Criteria:

* Diagnostic uncertainty
* Patients who are not suitable for general anesthesia
A Prospective, Open Label, Dose-escalation, SAD/MAD, Multicenter, 24weeks, Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamics of Investigational Product (VM-001) in Patients With Graft-versus-host Disease(GvHD)

The present study is multi center, phase I/IIa clinical trial to evaluate the safety and pharmacodynamics of investigational Product (VM-001) in patients with graft-versus-host disease(GvHD). A total of 12 subjects (Part 1 SAD\[3 cohort(2 subjects/cohort)\], Part 2 MAD\[2 cohort(3subjects/cohort)\]) are recruited.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥19 years of age
* Acute GvHD or chronic GvHD after hematopoietic stem cell transplant
* Subjects who no longer have available standard treatment.
* ANC≥1,000cells./mm\^3
* AST, ALT, total bilirubin less than 3 times the upper limit of normal
* serum creatinine less than 1.5 times the upper limit of normal

Exclusion Criteria:

* Received an anti-thymocyte globulin(ATG) within 14 days before enrollment
* FCV or FEV less than 70%
* Any uncontrolled infection or active infection requiring ongoing systemic treatment
* Received an investigational agent within 6 months before enrollment.
* Evidence of bleeding diathesis or coagulopathy.
* Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
* Breastfeeding or pregnant.
Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade

The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with BPH for whom alpha-blocker treatment is indicated
* Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available

Exclusion Criteria:

* Patient's follow-up not possible
* Patients participating in another study
* History of BPH surgery
* Prostate cancer
A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients with Retinitis Pigmentosa and Choroideremia (ABACUS)

A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS). Open label.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).
2. Have a visual acuity of:

   1. no light perception for Cohort 3 or
   2. no light perception or bare light perception for Cohort 1 confirmed with a LogMar \>2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
   3. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT.
3. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of \< 0.05 using the BRVT.

Exclusion Criteria:

1. Have evidence of material/substantial optic nerve disease.
2. Have a history of retinal detachments.
3. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media.
4. Have high intraocular pressure (IOP) \>22 mm Hg.
5. Have had a previous intraocular surgery (excluding phakocataract surgery).
6. Have aphakia.
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture

The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)

There are several studies similar in wrist fracture.

Eligibility Criteria:
Inclusion Criteria:

* ankle fracture within 3 weeks after the fracture

Exclusion Criteria:

* pregnant or lactating woman
* open fracture
* already treated with vitamin c
* chronic renal failure
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

* nausea
* vomiting documented in the ED

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the ED with at least one of the following
* Nausea
* Vomiting documented in the ED

Exclusion Criteria:

* Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
* Patients with missed last menstrual period
* Pregnancy
* Age \< 18 years old
* Treatment with antineoplastic agents within 7 days prior to randomization
* Irritable bowel syndrome
* Gastroparesis
* Suspected gastrointestinal bleed
* Suspected intestinal obstruction
* Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
* Traumatic brain injury upon admission to ED
* Intracranial hemorrhage upon admission to ED
* Patients unable to read, write or communicate in the English language
* Patients leaving the ED against medical advice
The Internal Prospective Validation of the Cancer Admission Score (CAS) Prediction Model

The goal of this single center prospective observational study is to determine the agreement between the cancer admission score (CAS) predicted disposition and the actual disposition in patients with an active cancer diagnosis visiting the emergency department (ED). The main question it aims to answer are: Is the performance of the CAS good enough to play a potential role in the ED care process. For each participant the CAS will be calculated and compared to the actual outcome.

The goal of this single center prospective observational study is to determine the agreement between the cancer admission score (CAS) predicted disposition and the actual disposition in patients with an active cancer diagnosis visiting the emergency department (ED). The main question it aims to answer are: Is the performance of the CAS good enough to play a potential role in the ED care process.

The first part of this study is an observational part. For patients with cancer that are presented to the emergency department (ED) the cancer admission score (CAS) will be calculated by the model both after triage and after the first blood results are in. Furthermore, the expected disposition will be asked to the attending nurse after triage and after the first blood results. Finally, the actual disposition will be written down after the patient has left the ED, in combination with ED length of stay (LOS) and the time for the attending physician to reach a decision about the disposition (time-to-disposition) and the time for a patient to leave the ED (time-to-leave).

The second part is the interventional part. In this part we introduce an early bed reservation intervention. The CAS is still calculated for the patient. If the CAS is 80% or higher based on the triage, the attending physician will be alerted and a call to the bed coordinator will be placed to reserve a bed in advance. After the first blood results are known the second CAS will be calculated, if this drops below 70% the reserved bed can be canceled by the attending physician. Similar to the first part, the expected disposition from the attending nurse after triage and after first blood results will be collected. Finally, the actual disposition, ED LOS, time-to-disposition and time-to-leave will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months.
* Presented at or admitted from the emergency department for the oncology, hematology neuro- or lung-oncology clinical unit.

Exclusion Criteria:

* \<18 years old
* Only received a surgical intervention as cancer treatment
* Admitted to the ED for the surgical department