cyrilzakka/clinical-trials huggingface dataset:
Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis

The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.

The aim of this study was to evaluate the efficacy and safety of The therapy of bronchoalveolar lavage and local amikacin injection through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 30days, 60days, 90days.all the participants will be required to check the various efficacy and safety indicators.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years and ≤80 years;
2. Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
3. Are sensitive to amikacin;
4. Acute exacerbation of bronchiectasis;
5. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;
6. Willing to join in and sign the informed consent form.

Exclusion Criteria:

1. Active bleeding without control；
2. Receiving nasal or facial surgery recently；
3. With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.
4. With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
5. Be allergic to amikacin
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

OBJECTIVES:

* Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
* Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Eligibility Criteria:
Inclusion Criteria:

Male patients will be studied who have prostate cancer:

* Diagnosed with prostate adenocarcinoma
* Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
* Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:

  * Gleason score \>= 7 or PSA \>= 10
  * Gleason score \< 7 or PSA \<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
  * Rising or non-responding PSA

Exclusion Criteria:

* \< 18 years old
* claustrophobic patients
Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors

This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old, regardless of gender
* advanced gastrointestinal tumors confirmed by histopathology or cytology;
* patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；Each line of treatment for advanced disease includes one or more drugs for one or more cycles； The pre-permissible treatment was combined with molecular targeted drugs (except endostar)； Patients with previous PD-1 treatment were eligible
* ECOG-PS score of 0-2
* The main organ function was normal and met the following requirements: Blood routine examination (no blood transfusion within 14 days) : a. HB≥80g/L; b. ANC ≥1.5×109/L; c. PLT ≥60×109/L; ② Biochemical examination should meet the following criteria: a. BIL\<1.5 times the upper limit of normal (ULN); b. ALT and AST\<2.5×ULN; ALT and AST\< 5×ULN，if liver metastasis was present; c. Serum Cr≤1×ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula)
* predicted survival time ≥3 months
* Patients voluntarily participated in this study and signed the informed consent form (ICF)

Exclusion Criteria:

* hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure\>140 mmHg/diastolic blood pressure \>90 mmHg); Patients with ≥ grade Ⅱ coronary artery disease, arrhythmia (including QTc prolongation \> 450 ms in men and \> 470 ms in women) and cardiac insufficiency
* patients with active immune diseases
* abnormal coagulation function (INR\>1.5×ULN, APTT\>1.5×ULN) with bleeding tendency
* symptomatic central nervous system metastasis
* pregnant or lactating women
* Other patients deemed ineligible for enrollment by the treating physician
Analysis of the Pachychoroid Phenotype in an Asian Population

The understanding of pachychoroid phenotype is incomplete. It is important to understand the risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease phenotype, to guide appropriate management of these patients.

The progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well established and the pathophysiology of these phenotypes remains unknown: specifically if the occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal attenuation.

A longitudinal study of the pachychoroid phenotype will provide much needed information regarding the natural history of the pachychoroid phenotype. Secondly, a detailed chronicle of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the pathogenesis, and facilitate the development of disease modulation strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least one eye.
2. Subfoveal choroidal thickness \>300 microns on enhanced depth imaging optical coherence tomography for at least one eye
3. Male or female patients above 45 years of age
4. Willingness to undergo pupil dilation, and protocol- required procedures for both eyes
5. Willing to provide written informed consent

Exclusion Criteria:

1. Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including Spectral domain- optical coherence tomography during the study period
2. Pregnant or nursing women
Elder-friendly Approaches to the Surgical Environment (EASE) Study

The aim of this study is to examine the impact implementing an elder-friendly surgical unit has on post-operative complications, mortality and quality of life for patients ≥ 65 years old who have undergone emergency surgical care.

The investigators hypothesize that the elder-friendly surgical unit will reduce in-hospital complications and mortality in a cost-effective manner, for this at risk population.

Specific elder-friendly interventions include:

1. Locate all elderly surgical patients on one nursing unit
2. Interdisciplinary team-based care
3. Elder-friendly evidence-informed practices including: comfort rounds with early mobilization, delirium prevention/management, optimal nutrition and prevention of post-operative complications
4. Early and interdisciplinary discharge management

This is a prospective, before-after study with a concurrent control group. Four senior patient groups will be followed:

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 65 years old admitted for Acute care and Emergency Surgery
* Received acute abdominal surgery

Exclusion Criteria:

* Elective general surgery cases
* Nursing home resident requiring full nursing care \[dependency in 3 or more activities of daily living \]
* Palliative surgery \[surgery with the primary intention of improving quality of life or relieving symptoms caused by advancing non-curative disease\]
* Multi-system trauma
* Patients from out of province or transferred from another inpatient service or hospital
Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.

After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group).

Patients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups.

The patients' pain levels were evaluated during 3 dialysis sessions.

Eligibility Criteria:
Inclusion Criteria:

Comfortable reception of trill and murmur sound from arteriovenous fistula,

• over the age of 18 and no communication problems,

* Having a place and time orientation,
* No dizziness,

Exclusion Criteria:

* Hemodialysis of the patient with arteriovenous graft and/or central venous catheter
* Pharmacological application was made to relieve pain 30 minutes before AVF cannulation,

  * The patient has a COVID - 19 infection
  * Having visual, auditory and intellectual disabilities,
  * Having a communication problem,
  * Not willing and willing to participate in the study, as well as wanting to withdraw from the study at any stage of the study
The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.

Patients undergoing colonoscopy were divided into progressive relaxation exercises and control groups. Pretest and posttest abdominal pain and distention scores of the patients were determined after colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy
* Those who do not have communication problems,
* After the colonoscopy procedure, the abdominal pain score is evaluated by VAS and is 4 or higher,
* Evaluation of the distension score of 4 and above with VAS after the colonoscopy procedure,
* Be 18 years old or older.

Exclusion Criteria:

* Being a hospitalized patient undergoing colonoscopy,
* Be younger than 18 years old
* To have used complementary and alternative methods during the research,
* Any physical problem that may prevent you from doing the exercises,
* Having a cognitive illness
* Refusing to participate in the research,
* Failing to complete surveys.
The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women

Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.

Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.

This study was planned as a randomized controlled experimental study to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol levels. It will be conducted in a randomized parallel controlled experimental design using Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women applying to the infertility outpatient clinic of Health Sciences University Ümraniye Training and Research Hospital in Ümraniye district of Istanbul province will constitute the sample population of the study. Women applying to the infertility outpatient clinic who meet the inclusion criteria and who voluntarily agree to participate in the study will be included in the study. According to the power analysis, a total of 86 infertile women, 43 in the intervention group and 43 in the control group, will constitute the sample of the study. While Mindfulness-Based Stress Reduction Program will be applied to the intervention group with the zoom program, which is an online training platform, routine follow-up will be applied to the control group within the scope of outpatient follow-up of the relevant institution. The participants included in the study will be administered the Informed Voluntary Consent Form, Descriptive Characteristics Information Form, DASS-21, Perceived stress scale and Salivary cortisol test as part of the pre-test. Within the scope of post-test and follow-up test, DASS-21, Perceived stress scale and Salivary cortisol test will be applied again.

Discussion and conclusions of the study will be written as a result of the findings

Eligibility Criteria:
Inclusion Criteria:

* - Agree to participate in the 8-week MBSR training
* Having completed the Informed Consent Form and volunteering to participate in the study
* Speaking and understanding Turkish
* Idiopathic infertile women
* Primary infertile women
* YTU treatment has not started
* Having attempted YTU at most three times before
* Be able to use ZOOM program

Exclusion Criteria:

* - Illiteracy,
* The woman has a cognitive and auditory problem,
* Having a chronic disease
* Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.)
* Having participated in any awareness-based training program in the last 1 year

Exclusion Criteria

- Not participating in any session of the 8-session training program, not participating in any of the Pre-test, Post-test-1 and Post-test-2

Being an infertile woman
Mild Traumatic Brain Injury Registry

The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
* Must be awake and alert (Glasgow Coma Scale 13-15)
* Must be enrolled within 72 hours of injury
* Must have CT or MRI neuroimaging performed

Exclusion Criteria:

* Diabetes Mellitus with severe complications
* Intoxication at time of enrollment
* Major psychiatric disorder that is poorly controlled
* Prior stroke
* History of Social Security defined "disability
* Uncontrolled Seizure Disorder
* Incarceration or arrest
* Concurrent Injury requiring hospitalization
* Use of anticoagulant drugs
* Any condition the investigator deems as inappropriate for patient enrollment
* Personality disorder
* Heart, liver or kidney failure defined using common clinical practice guidelines
* Baseline cognitive impairment
* Homelessness
* TBI associated with interpersonal violence
* Pregnancy
* Long bone fracture requiring surgical stabilization
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis

This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Be able and willing to provide written informed consent
* Be male or female, 18 to 70 years of age (inclusive)
* Have a body mass index (BMI) ≥ 20.0 and \< 40.0 kg/m2
* Well-compensated cirrhosis
* Negative for hepatocellular carcinoma (HCC)
* Adequate safety laboratory values at Screening.
* Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine
* If of child bearing potential must follow contraceptive requirements of the protocol
* Have reliable internet access

Exclusion Criteria:

* Have evidence of decompensated liver disease.
* History or active GI disease.
* Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
* Subject has a history of drug and/or alcohol abuse.
MRS to Determine Neuroinflammation and Oxidative Stress in MPS I

Neuroinflammation and oxidative stress have been shown to be present in persons with mucopolysaccharidosis type I (MPS I), but their effect on disease severity and disease progression is unknown. The investigator intends to employ brain magnetic resonance spectroscopy (MRS), a non-invasive technique, along with analysis of neuroinflammation and oxidative stress biomarkers in the blood, to measure and determine the level of oxidative stress and neuroinflammation, and their impact on clinical variability in MPS I patients.

Persons with MPS I have a wide range of clinical manifestations including central nervous system (CNS) impairment. The role of neuroinflammation and oxidative stress is one avenue of investigation which may clarify the broad neurological impairment in MPS I. Finding biomarkers that accurately describe the underlying and ongoing brain pathology is a key not only to understanding the disease, but also to understanding the possibility of new therapeutic approaches for MPS I patients.

The investigator will compare patients with Hurler syndrome, and Hurler-Scheie or Scheie syndrome, with healthy controls. There will be 10 participants in each group, resulting in a total of 30 participants. Within the Hurler-Scheie or Scheie syndrome group, the investigator will examine the association of clinical severity with the proposed measures. These findings might help determine whether hematopoietic cell transplantation (HCT), which is the treatment for Hurler syndrome patients, results in decreased oxidative stress and neuroinflammation as compared to Hurler-Scheie or Scheie syndrome patients, who are treated by enzyme replacement therapy (ERT). Additionally, these findings might help determine whether therapies directed at reducing neuroinflammation and oxidative stress in MPS I could enhance neurological outcomes.

Study hypothesis: neuroinflammation and oxidative stress are present in MPS I subjects and are reflective of disease severity.

Eligibility Criteria:
Inclusion Criteria:

MPS I participants must meet the following:

1. Diagnosis of Hurler syndrome, OR Hurler-Scheie syndrome, OR Scheie syndrome
2. 6 years of age or older at time of screening

Healthy control participants must meet all of the following:

1. Absence of neurological disorder
2. 6 years of age or older at time of screening

Exclusion Criteria:

Persons who have any of the following will not be enrolled in this study:

1. Any surgically implanted pacemaker
2. Any indwelling electronic device, including programmable shunts
3. Orthodontic braces, unless non-metallic
4. Other implanted metal in the body other than titanium
5. An inability or unwillingness to complete an MRI/MRS because of low cognitive function or behavioral dysregulation
6. Pregnancy
Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).

Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD).

An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 6 and 17 years of age, inclusive
* Diagnosis of ADHD of the hyperactive or combined inattentive/hyperactive subtypes according to DSM-IV criteria
* Minimum score of 26 on the ADHDRS-IV questionnaire at Baseline
* General good health as judged by the Principal Investigator
* Body mass index ≥ 5th percentile of the subject's age group according to the CDC growth chart.
* Ability to swallow tablets
* General IQ ≥80 as judged by the Principal Investigator
* Subject as well as parent/guardian able to sign informed assent or consent form.

Exclusion Criteria:

* If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or IUD
* Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
* Presence of clinically significant abnormality on centrally interpreted Electrocardiogram (ECG) readings
* History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant Axis I or Axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
* History of concomitant conduct disorder (CD)
* History of seizures, except for a single episode of febrile seizure prior to age 2
* History of syncopal episodes
* Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
* History of intolerance to clonidine, including any dermatologic reaction to transdermal clonidine
* Presence or history of alcohol or drug abuse
* Positive drug screen, with the exception of ADHD drugs
* Use of any investigational drug within 30 days of study start.