cyrilzakka/clinical-trials huggingface dataset:
Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)

Because anidulafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although anidulafungin is approved for the treatment of invasive candidiasis in adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as well as other echinocandins) in this specific patient population is still largely unknown. During endoscopic gastric bypass surgery, patients are more prone to various kinds of infection, justifying the prophylactic use of anidulafungin in this specific cohort of patients.

To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics in a normal-weight group.

All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12, 24, and 48 and (if feasible) 72 hours post infusion (n=12 samples). Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
2. Subject is at least 18 years of age on the day of screening.
3. If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
4. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
2. History of, or current abuse of drugs, alcohol or solvents.
3. Inability to understand the nature of the trial and the procedures required.
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules. \[18F\]Fluoroglutamine PET may provide additional information that help diagnose lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients are given the opportunity to participate in the study if

  1. Age between 18-79;
  2. The patient must be able to give informed consent;
  3. Sexually active subjects agree to use condoms and/or their partners of reproductive potential to use a method of effective birth control during imaging period of 2 weeks;
  4. Patients can finish PET/CT scan without tranquilizers;
  5. Patients with a newly diagnosed, untreated primary lung cancer; Or patients older than 55, current or former smoking with ≥ 30 pack years, and newly discovered indeterminate pulmonary nodules (7-30 mm diameter) on CT.
  6. No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT.

Exclusion Criteria:

* Patients with any of the following conditions will be excluded

  1. Pregnant or lactating patients;
  2. Patients with active lung infection;
  3. Inability or refusal to have at least one peripheral intravenous line for intravenous access;
  4. From assays obtained \<2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin\>1.5\*ULN,AST/ALT \>2.5 \* ULN, Albumin\< 3 g/dl, GGT \> 2.5 x ULN if ALP\> 2.5 x ULN, Creatinine\>1.5\*ULN or creatinine clearance \<60ml/min；
  5. Patients with a history of allergic reaction to this drugs or its analogues；
  6. patients with poor compliance;
  7. Acute major illness
Standard Telephone Consultation for Pain

The purpose of this study is to investigate whether pain control for patients with chronic pain is improved by the availability of structured telephone consultations between the patients' family physicians and pain physicians, compared to pain control for patients receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* patients referred to Alberta Health Services chronic pain center in Calgary with neurological or muscular skeletal pain

Exclusion Criteria:

* increased risk for suicide, very complex patients, family physician could not reliably identify patient's pain problem, or condition warranted expedited consultation with pain physician, case represented a new presentation of chronic regional pain syndrome, or low back pain with radicular symptoms or sciatica
Oculomotor Training Improves Reading Eye Movement

Children with reading eye movement problems were recruited for this study. The treatment group was provided with oculomotor training for 8 weeks, the control group was given placebo exercises.

Purpose of study Reading is one of the integral elements for learning and poor readers were reported to have less efficient reading eye movements. They were typically characterized by having higher number in fixation and regression, reduced reading speed and perceptual span. The purpose of this study was to investigate if vision therapy which limited to training of oculomotor skills can improve reading eye movement.

Methodology This was a randomized, prospective study. 30 subjects aged from 8-9 years of age with reading difficulties and reading eye movement problems were recruited. They all have normal intelligence and ocular health, but failed to meet the Taylor reading eye movement norms when tested with the Visagraph III. The subjects were randomly assigned into either the treatment group (15) or the control group (15). The treatment group had to go through a course of oculomotor vision therapy and the control group was given placebo exercises. Vision therapy for the treatment group involved 8 weeks of training (office training - 3 times a week, 30 min per session; home training - 4 times a week, 30 min per session). Office training involved the use of Vis-Flex (Visual Flexibility Trainer - an electronic device with L.E.D. lights which can display various flashing patterns at variable speeds). Home training involved several saccadic eye movement exercises. Subjects and parents were also asked to grade the reading symptoms checklist before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Reported by teachers or parents to have reading difficulties and failed to meet the Taylor reading eye movement norms when tested with the Visagraph III (below age norm for both fixation and regression number).
* Studying in mainstream primary schools (8-9 years of age)
* With normal near visual acuities for both eyes (with or without spectacles)
* Hyperopia below +4.00 D
* Myopia below -4.00 D
* Astigmatism below -2.00 D
* Anisometropia less than 2.0 D difference between the two eyes
* Near heterophoria within 0-4 exophoria
* Vertical heterophoria less than 1 prism dioptre
* Monocular amplitude of accommodation over 10 D in both eyes
* With parents who were willing to perform vision therapy exercises for the children at home on a regular basis
* Both genders were acceptable as Eden et al (1994) stated that gender had no effect on oculomotor skills

Exclusion criteria:

* With strabismus
* Presence of eye diseases
* History of dyslexia (learning disability) or developmental delay
Observational Study of the Decision Making Towards Clinical Trials in Cancer Patients

This is a cross-sectional, observational and correlational survey study.This study is aim to survey the the knowledge, attitudes, and decision making towards clinical trials in cancer patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been experienced the treatment clinical trials' informed consent process. The research tool is a questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4) Satisfaction with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The investigators expect the research outcome can provide some instructions to improve patients' autonomy, satisfaction of the decision making and communication process between patients and Medical professors whenever cancer patients participating in clinical trials.

This study is been conduct in National Taiwan University Hospital , Taiwan. The main measurement tool is a self-report questionnaire, which is designed to answer some outcome measures for the following aspect:

1. To find out the knowledge, attitudes, shared decision making level, subjective norm, and behavior intentions towards clinical trials in cancer patients.
2. To find out the main influencing factors of behavior intentions towards participating in clinical trials

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients who have been approved lung cancer or liver cancer.
2. Patients who have been experienced the Informed consent process about clinical trial, which duration is in 6 months before they enter this study.

Exclusion Criteria:

1. Patients who have conscious disorientation that can not answer questionnaire
2. Patients only participate in some Gene clinical trials without treatment or drugs.
Endodontic Root-canal Treatments Evaluated After Long-term Time

The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.

See previous papers (Pirani et al., Odontology, 2015)

Eligibility Criteria:
Inclusion Criteria:

Patients affected by endodontic disease and able to attend a recall hygien program

Exclusion Criteria:

* Sistemic disease Cancer Inability to attend a recall hygien program
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes

BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
* Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
* Body Mass Index (BMI) of 18 to 40 kg/m2
* Fasting glucose in the range of 100-250 mg/dL
* Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%

Exclusion Criteria:

* Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
* Past history of diabetic ketoacidosis and/or C-peptide \< 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon the absorption of study drug
* Smoking more than 10 cigarettes per day
* Recent drug or alcohol abuse
* Women who are pregnant or breastfeeding
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
Varenicline Effects In Schizophrenic Smokers

This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
* Recent History of Cigarette smoking
* Ages 18-65
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension

The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH).

Part A:

An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants.

Part B:

A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.


Eligibility Criteria:
Key Inclusion Criteria Part A:

* overtly healthy
* Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.

Key Exclusion Criteria Part A:

* clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
* smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.

Key Inclusion Criteria Part B:

* diagnosis of pulmonary arterial hypertension (PAH)
* stable dose of standard of care PAH vasodilators
* BMI 16 to 32 kg/m2; and a total body weight \>45 kg.
* 6MWD ≥ 150 and ≤ 450.
* Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.

Key Exclusion Criteria Part B:

* Any medical or psychiatric condition or laboratory abnormality.
* Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
* Pulmonary capillary wedge pressure \> 15 mmHg on right heart catheterization (RHC) conducted during Screening.
* History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
* Major surgery within 8 weeks prior to randomization.
* Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.

The main objectives of the study are (1) to investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gastroesophageal reflux disease symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders and approximately 50-80% of the GERD patients experience nocturnal gastroesophageal reflux symptoms. Symptoms at night have a negative impact on sleep quality, daytime functioning and quality of life. When sleeping in left lateral decubitus position, the stomach is positioned below the esophagus, resulting in less reflux compared to sleeping in right lateral decubitus position. Sleep positional therapy, using an electronic wearable device which gently vibrates in an annoying way when turning in the sleep to the disadvantageous right lateral decubitus position, stimulates subjects to avoid sleeping in the right lateral decubitus position and effectively alleviates nocturnal gastroesophageal reflux symptoms. This prospective single center interventional pilot study will aim to (1) investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with GERD symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Both male and female patients will be included.
* Age 18 years or older.
* Symptoms of heartburn and/or acid regurgitation during at least three nights a week.
* A total reflux symptom score ≥8 (measured through the GERDQ questionnaire score).
* Able to wear the Apple Watch on the left wrist.

Exclusion Criteria:

* Complete PPIs non-responders.
* Nightshift workers
* Surgery of the esophagus or stomach.
* Regular use of sleep medication (benzodiazepines) or medication which affect gastrointestinal motility (e.g. prokinetics or opioids) that cannot be stopped during the duration of the trial.
* Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
* Patients with obstructive sleep apnea or esophageal motility disorders.
* Pregnant or lactating women.
A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects

The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K.

Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive
* The subject has been a non-smoker for at least 3 months prior to check-in
* The subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study period
* The subject's clinical laboratory test results are within normal limits
* The subject is medically healthy, with no clinically significant medical history or abnormalities

Exclusion Criteria:

* The subject has a history of any clinically significant gastrointestinal, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer
* The subject has a history of malabsorption syndrome or previous gastrointestinal surgery that could affect drug absorption or metabolism
* The subject has a recent history of irregular defecation, such as constipation or diarrhea
* The subject has a history of drug or alcohol abuse, or a positive urine screen for alcohol or drugs of abuse/illegal drugs
* The subject has had treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter (OTC) medication within past week
* The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
* The subject is known positive for human immunodeficiency virus (HIV) antibody
* The subject has a positive test for hepatitis C antibody, or positive test for hepatitis B antigen (HBsAg)
* The subject has positive tuberculosis (TB) or Quantiferon Gold test
* The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
* The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
* The subject has had exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
* The subject has participated in a radio-labeled-study within the last 6 months, participated in more than one other radio-labeled study within the past 12 months
Reversal of Tobacco-Related Sinusitis

This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.

By using patient screening questionnaires and measuring hair nicotine, a well acknowledged biomarker of exposure to tobacco smoke, we will attempt a more objective study to examine the association between tobacco smoke and chronic rhinosinusitis. (CRS) Likewise, zinc deficiency is documented in numerous animal and human studies to decrease resistance to infectious diseases and is especially common among smokers. We will explore our hypothesis that SHS exposure and zinc deficiency contribute to CRS. To accomplish this, we will measure serum zinc and hair nicotine levels in CRS patients and correlate them to a variety of CRS diagnostic indicators. A second objective of this study is investigating alterations within the epithelium lining the sinonasal cavities in patients with chronic rhinosinusitis. The alterations may be one or a combination of anatomic, genetic, inflammatory, or infectious etiologies. To further investigate these possibilities we plan on taking residual clinical material from endoscopic sinus surgery specimens and performing various in vitro investigations including but not limited to microarray analysis, northern and western blot analysis, ciliary beat frequency analysis, immunohistochemistry, electron microscopy, and propagation of tissue with tissue culture techniques. Tissues taken from non-sinusitis patients undergoing sinonasal surgery will serve as a non-chronic rhinosinusitis control source of sinus mucosa.

Eligibility Criteria:
Inclusion Criteria:

* CRS and skull base surgery patients; CRS patients that meet the objective and subjective guidelines for CRS set forth by the Sinus and Allergy Health Partnership.

Exclusion Criteria:

* Ciliary dysfunction, autoimmune disease, CF or any known immunodeficiency.