cyrilzakka/clinical-trials huggingface dataset:
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study.

Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
* BMI ≥ 18.5 to \< 30.0 at time of screening tests

Part 2:

* Men and women aged 18 years or older at the time of consent
* Patients with EASI ≥ 16 in pre-administration testing
* Patients with IGA of "3: Moderate" or higher in pre-administration testing
* Patients with BSA ≥ 10% at screening in pre-administration testing

"Exclusion Criteria:

Part 1:

* Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
* Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
* Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
* Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
* Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
* Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period

Part 2:

* Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c \> 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
* Patients observed to have one of the following laboratory test abnormalities in screening tests

  * Neutrophil count: \< 1500/μL
  * Serum creatinine: \> 1.5 mg/dL
  * AST or ALT: \> 2.5-fold the upper limit of the reference range
  * Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial
MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy

Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI) are advancing imaging technologies that have potential to overcome limitations of conventional staging methods, radiation treatment planning and the assessment of tumor response in esophageal or esophagogastric cancer. This study aimed to explore the value of MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume delineation as compared to CT simulation for patients with unresectable or potentially resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT texture features are also extracted before and during treatment to establish a model to predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of patients.

1. Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22 fractions. Also MRI will be performed after treatment. The investigators will contour based on the MRI image and compare this with the standard CT plan before and during treatment.
2. The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed.
3. The average CT texture features not only in the present study but also of those who treated previously in our department (since 2014) will be extracted before and during chemoradiotherapy to establish a model to predict the prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction
* Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th) based on standard primary staging by EUS and CT
* Age\>18 years
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation or chemotherapy
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Contraindication for MRI scanning
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* Pregnant or lactating females
* Contraindication for radiotherapy or chemotherapy
Siemens VOC TB Pilot Study

Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.

Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown.

This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection.

The study is comparing 3 groups of patients:

* patients with confirmed active pulmonary tuberculosis (n=20)
* patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20)
* healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured.

Hypothesis:

The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or healthy subject that is not employed or working at the study site
2. Oral and written consent to study participation

Exclusion Criteria:

1. Tuberculosis therapy \>1 week
2. Inability to follow the study requirements
3. Patient in custodianship or guardianship
4. Other lung diseases that are not listed in the inclusion criteria.
Four Pillars of Defense: A Whole Health Approach to the Military

The overall objectives of this study are to better define the construct of psychological resilience in the military, to identify potential modifiable risk factors and trainable skills of psychological resilience in Soldiers, and provide a scalable, integrated physical and mental optimization training app to be integrated into relevant systems. The proposed work would be a first step in identifying predictive risk factors that can be modified to increase the future resilience of Soldiers. With this crucial information, the investigators aim to gather data that will inform the development of a resilience-focused intervention (e.g., a skills training program) and test the feasibility of that intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age 21+ and either a Soldier in the NG or NG family member

Exclusion Criteria:

* Under age 21 and not an NG Soldier or family member
Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent prior to any study-related procedures.
* Patients should have an established diagnosis of IPF.
* Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values.
* Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation \> 80%

Exclusion Criteria:

* Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion.
* Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions;
* History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin.
* History of clinically significant respiratory diseases other than IPF.
* History of clinically significant cardiac, hepatic, or renal disease.
* History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening.
* Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening.
* Other pathology that might interfere with the assessment of the safety or efficacy of the test article.
* Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status

The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.


Eligibility Criteria:
Inclusion Criteria:

* Ketogenic diet cohort: currently following a ketogenic or low-carbohydrate diet defined as less than 30 grams per day (ketogenic) or less than 100 grams per day (low-carbohydrate) as estimated by the individual. Subjects must have been following the diet before the beginning of the study period and must continue with the diet throughout the duration of the trial.
* High-carbohydrate diet cohort: currently following a diet that does not restrict dietary carbohydrate. Carbohydrate consumption should be greater than 100 grams per day as estimated by the individual. Subjects must have been following the diet before the study period and must continue with the diet throughout the duration of the trial.

Exclusion Criteria:

* Type-1 diabetes
* Insulin-dependent type-2 diabetes
* History of diabetic ketoacidosis
* Currently taking Warfarin or other blood thinners
* Currently taking a sodium-glucose cotransporter-2 (SGLT2) inhibitor
* Currently taking Disulfiram
* Unwilling to maintain their diet during the study period
* Unwilling to test blood and breath ketones five times per day
* Non-English speaking
* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)

The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect on lung function in patients with CF than placebo (0.17% saline).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 12 years of age or older.
* Diagnosis of cystic fibrosis as determined by the 1997 CF Consensus criteria (NIH Consensus Statement, 1997)
* Non-smoker
* FEV1 at Screening Visit 1 between 40% and 90%
* Stable regimen of CF medications and chest physiotherapy for the 28 days prior to Screening. Must be willing to discontinue use of hypertonic saline for the duration of the study.
* Clinically stable for at least 2 weeks
* All females of child-bearing potential must have a negative serum pregnancy test and if sexually active must agree to practice a highly effective form of contraception throughout the study and for 28 days after the last dose of study medication.

Exclusion Criteria:

* History of any organ transplantation or any significant disease or disorder
* Use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs or trimethoprim in the 28 days prior to Screening
* History of significant intolerance to inhaled hypertonic saline, as determined by the Investigator
* Known hypersensitivity to the study drug or amiloride
* Any clinically significant laboratory abnormalities at Screening Visit 1 as judged by the investigator, or any of the following:

  * Potassium ≥ 5 milliequivalent per Liter (mEq/L)
  * Abnormal renal function
  * Abnormal liver function, defined as ≥ 3 x upper limit of normal (ULN)
  * Hemoglobin level \< 10.0 g/dL
* Female who is pregnant or lactating
* History of sputum or throat swab culture yielding Burkholderia species or Mycobacterium abscessus within 2 years of screening
* Has previously participated in an investigational trial involving administration of any investigational compound or use of an investigational device with 28 days prior to Screening
* Currently being treated with any ivacaftor containing regimen
Melatonin for Treatment of Delirium in Critically Ill Adult Patients

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.

The prevalence of delirium is high in the intensive care unit (ICU), yet there is no pharmacological treatment that has been proven effective. The investigators hypothesize that melatonin, given on a daily basis at 21:00, will safely decrease the mean duration of a delirium episode in ICU patients. The current literature evaluating melatonin as a treatment for delirium is lacking, therefore more studies are needed.

It is estimated that an alteration of sleep pattern can be found in up to 75% of patients with delirium. This raises the hypothesis that prevention and treatment of sleep disorders could potentially improve delirium. Sleep and circadian rhythm disturbances are associated with low endogenous melatonin secretion and studies have shown that it also occurs in patients with delirium.

Thus, the objective is to conduct a phase II double blind, placebo-controlled randomized trial comparing melatonin 9 mg to placebo to evaluate the feasibility of a future large-scale RCT. Participants will be followed during their stay in the ICU and after their transfer on another unit up to a maximum of 14 days. Feasibility of the larger trial will mainly be based on enrollment rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older admitted to the intensive care unit;
* Anticipated ICU stay \> 48 hours;
* ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.

Exclusion Criteria:

* Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;
* Use of melatonin within 24 hours prior to randomization;
* Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy;
* Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;
* Presence of active seizures, coma, aphasia or severe intellectual disability;
* Limited short-term vital prognosis;
* Diagnosis of delirium prior to ICU admission;
* Pregnancy or breastfeeding;
* Absolute contraindication to receive enteral medication;
* Inability to understand or speak English or French;
* Total blindness.
Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients aged 18-75 years
2. Referred for routine diagnostic colonoscopy
3. Patients who have signed inform consent form

Exclusion Criteria:

1. pregnancy or breastfeeding
2. allergy to purgatives
3. suspected intestinal obstruction, stricture, or perforation
4. hemodynamic instability
5. impaired swallowing reflex or mental status
6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
7. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
8. participation declined.
Brain Sleep Deprivation MRI Effects (BEDTIME)

The primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. Subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG). Participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. They will seep inside an MRI machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.


Eligibility Criteria:
Inclusion Criteria:

* Age range 21-30
* Capable of giving informed consent

Exclusion Criteria:

* Diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
* History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
* Conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (PLMS) or Obstructive Sleep Apnea (OSA).
* History of claustrophobia.
* BMI≥30
* Significant history of alcoholism or drug abuse.
* Inability to avoid the use of alcohol or caffeine during the 48h before the MRI.
* Current pregnancy or intent to become pregnant during the period of study.
* Any electronic or ferromagnetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
* Any medications adversely affecting cognition, blood pressure, glucose metabolism, or sleep will result in exclusion.
Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?

The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. The investigators assumed that with the multimodal analgesia regimen without the use of IVPCA will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 to 80 years old
* Provision of written informed consent
* Patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only
* Patients with Body Mass Index (BMI) between 18 to 34.9
* Patients with American Society of Anesthesiologists (ASA) physical status classification of 1 to 3

Exclusion Criteria:

* Patients on chronic (more than twice a week) opioid treatment including Tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids
* Patients with language barrier or difficulty in communication in English
* Patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen
* Patients with increased risk for respiratory depression with intrathecal morphine (OSA, central apnea)
* Patients with documented Renal or hepatic impairment