cyrilzakka/clinical-trials huggingface dataset:
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.


Eligibility Criteria:
Inclusion Criteria

* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
* Body weight considering body mass index (BMI) within the range of 18 to 32 kilogram per meter square (kg/m\^2), inclusive.
* Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 55 years of age inclusive, at the time of signing the informed consent.

Exclusion Criteria:

* History or presence of/significant history of or current cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or study procedures or interfering with the interpretation of data.
* Past or intended use of over-the-counter or prescription medication including herbal medications within 28 days prior to dosing, with the exception of supplemental vitamins, hormonal medications (contraceptives or hormone-replacement therapy), or occasional oral acetaminophen (not to exceeding 2 g total daily dose).
* Current enrollment or past participation in another investigational/observational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days, or 5 half-lives whichever is longer.
* Positive COVID-19 screening test using PCR or antigen assay at Day -1
* Donation of, or significant blood loss of, more than 500 mL of blood within 56 days prior to dosing.
* Receipt of a blood transfusion within 1 year prior to enrollment or plasma donation within 7 days prior to dosing.
* QTc \>450 msec.

Note: Other inclusion/exclusion criteria may also apply
The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.

Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of CD8+T cells in the case of hepatitis and the function enhancement of CD8+T cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD8+T cells function, or recovery of CD8+T cells function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage CD8+T cells function, and the loss of HBsAg and HBeAg led to recovery of CD8+T cells function.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
The Modum Bad Complex Posttraumatic Stress Disorder Study

This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.

Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings.

96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).

Eligibility Criteria:
Inclusion Criteria:

* childhood trauma (e.g. sexual abuse, violence prior to age 18),
* a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5
* a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11)

Exclusion Criteria:

* severe psychotic disorder
* dissociative identity disorder (DID)
* active phase substance dependence
* acute suicidality
* major current life crisis
* severely disturbed group functioning
* mental disability
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. Currently, patients with transplant-related lung disease are treated with some combination of steroids and other immunosuppressant drugs, but only about 1 out of 5 improve.

The importance of our study is that the investigators aim to prevent the development of transplant-related chronic lung disease in the first place. Because a strong risk factor for such chronic lung disease is a prior viral respiratory tract infection, the investigators think there is a window of opportunity to intervene. As soon as "cold and flu" symptoms start, the investigators will treat patients with a combination of drugs aimed at eliminating damaging immune responses triggered by the virus. In the absence of such treatment, the investigators believe these lung-damaging immune responses would persist even after the virus disappears. Our hope is that preventive treatment might avoid the development of chronic lung disease, and this would substantially increase long-term survival in our transplant patients.

This is a pilot study. Once feasibility is established, the investigators will seek to expand this study into a definitive clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic transplant within the prior 1 year
* Age greater than or equal to 18 years
* Capable of informed consent
* Neutrophil engraftment has occurred
* This is the first clinically-recognized episode of viral respiratory tract infection after transplant

Exclusion Criteria:

* Proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia
* CMV, VZV or HSV pneumonia
* Prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: BO, COP)
* Treating physician believes the risk of systemic steroids is too great
* Currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid
* Currently receiving pentostatin
* Mycophenolate initiated de novo or increased within the past 4 weeks
* Use of inhaled corticosteroids within the past 2 weeks for at least 1 week
* Haploidentical or T-cell depleted graft
* Lack of pre-transplant pulmonary function tests
* Evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not
* Allergy or adverse reaction to any of the study drugs
* Relapse or progression of the underlying malignancy
* Palliative care
Effect of Lubricating Gel for Pain Relief During Speculum Examination in Gynecologic Oncology Patients

Pelvic examination, an important part of gynecologic oncology patients to help detect cancers recurrence or infections.Despite its importance, many women are reluctant and anxious about the procedure because of fear, as well as discomfort and pain. The objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water in gynecologic oncology patients


Eligibility Criteria:
Inclusion Criteria:

\*Female patients WHO came for surveillance for malignant gynecologic disease such as uterine cancer, cervix cancer, and ovarian cancer with or without radiotherapy and chemotherapy

Exclusion Criteria

* Women were undergoing Vulvectomy or Vaginectomy
* Women with narrow vagina for standard medium size of speculum for examination
* Women who underwent fertility sparing surgery.
* Women had vaginitis
Partial Least Squares Regression Modelling for Glaucoma Detection

A partial least squares regression model for visual field testing among glaucoma patients will be developed.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* written informed consent prior to surgery
* any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".

Exclusion Criteria:

* Secondary glaucoma
* In case of pregnancy (pregnancy test will be taken in women of reproductive age)
The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study

Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a long-term effect on the risk of diabetes and provide evidence that early intervention by traditional Chinese medicine could delay the progression from impaired glucose tolerance to diabetes.

Study contents: 1.420 participants were followed up for 8 years to assess the long-term effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To participants that determined the status of glucose metabolism, a variety of ways were used to find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed to assess the state of glucose metabolism. 4. Questionnaires were given to all the participants to investigate their condition of treatment, diet, exercise and other lifestyle.

Study design: Perspective study Study drug: Tianqi CapsuleInclusion criteria: 1. Subjects have participated in the REDUCES study before; 2. Informed consent forms were needed to participants performed to blood test; 3. Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism; 4.Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.

Exclusion criteria: 1. Subjects did not participate the REDUCES study; 2. Subjects suffered serious mental illness; 3. Subjects suffered severe mental or cognitive impairment; 4. Subjects had a history of drug or alcohol dependence; 5. Subjects have participated in other drug clinical trials in the past 1 month.

Main outcome index: Incidence of diabetes. Secondary outcome index: Body mass index, fasting blood-glucose, postprandial blood sugar, blood lipids, blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have participated in the REDUCES study before;
* Informed consent forms were needed to participants performed to blood test;
* Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism;
* Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.

Exclusion Criteria:

* Subjects did not participate the REDUCES study;
* Subjects suffered serious mental illness;
* Subjects suffered severe mental or cognitive impairment;
* Subjects had a history of drug or alcohol dependence;
* Subjects have participated in other drug clinical trials in the past 1 month.
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients

This trial investigates how well bright white light therapy works in improving sleep, fatigue, distress, depression, and anxiety, side effects that are often experienced during an intense leukemia treatment regimen, in hospitalized leukemia patients. Bright white light therapy may help to control these symptoms, and information from this study may help doctors and nurses learn more about methods for decreasing these symptoms.

PRIMARY OBJECTIVE:

I. To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.

SECONDARY OBJECTIVES:

I. To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.

I. To assess the efficacy of BWLT on anxiety in patients diagnosed with leukemia during their hospitalization.

III. To assess the efficacy of BWLT on depression in patients diagnosed with leukemia during their hospitalization.

IV. To assess the efficacy of BWLT on distress in patients diagnosed with leukemia during their hospitalization.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

GROUP II: Patients receive standard of care during hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Acute Leukemia Unit for an anticipated stay of 3 weeks or longer
* English speaking
* Able to comprehend and sign a consent form
* Able to read and complete surveys
* Alert and oriented
* Without BWLT for seven days prior to initiating the trial

Exclusion Criteria:

* Current eye disorders which is defined as:

  * Iritis, uveitis, keratitis, cataract, glaucoma, macular degeneration, retinal detachment, or retinitis pigmentosa
* Diagnosed bipolar disorder
* Persons with pacemakers

  * The manufacturer of the BWLT unit used for this study mentions the light unit contains magnets
Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.

Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.

After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.

Eligibility Criteria:
Inclusion Criteria:

* patients allergic to grasses pollen
* patients with bronchial asthma
* patients with controlled asthma
* patients who were qualified for immunotherapy and gave written informed consent for immunotherapy

Exclusion Criteria:

* patients allergic for other perennial and seasonal allergens
* patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion

The study aims to evaluates if the treatment with HFCWO Via The Vest® Airway Clearance System, in addition to standard care in critically ill patients admitted in the Respiratory Intensive Care Unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute respiratory failure (ARF) or acute on chronic respiratory failure (including patients having home oxygen therapy, HFNC, NIV) both hypercapnic ARF (PaCO2 \> 45 mmHg; PaO2/FiO2 \<300) or hypoxaemic (PaCO2 \<45 mmHg; PaO2/FiO2 \<300);
* Informed consent from patient or legal tutor;
* Accessory respiratory muscles use;
* Respiratory rate above 25 apm;
* Use of non invasive respiratory therapy (NIRT) NIV+/-HFNC or HFNC alone since RICU admission
* Kelly neurological index ≤ 3
* Excessive airway mucus secretion (clinical evaluation asking the patient to cough) and inability to efficiently remove secretions (evaluated with the Cough Peak Flow (CPF) measurement. A CPF under 270 Lpm is highly suggestive of inadequate cough which prevent the patient from adequately manage and remove airway secretions.
* Cough score \< 3: in the case of inability to perform CPF measurement due to poor patient collaboration, cough adequacy will be evaluated by a respiratory physiotherapy with a semiquantitative score ("Cough score") based on the measurement of sputum volume produced after coughing three times (1 point: less than 2 mL, 2 points: 2-6 mL, 3 points: more than 6 mL).

Exclusion Criteria:

* Patient unwillingness or incapability to provide informed consent
* Need for subcontinuous NIV(more than 20 hours per day)
* Kelly neurological index \>3
* Cardiac arrest
* Severe haemodynamic instability (more than two amines required);
* acute coronary syndrome;
* Psychomotor agitation unresponsive to analgo-sedation (RASS\> 1)
* Contraindications to HFCWO use: acute pneumothorax (even if chest drainage is not required ); severe chest wall deformities (pectus excavatum, pectus carinatum or pectus arcuatum); severe obesity (BMI \>40 kg/m2); pregnancy; thoracic or abdominal surgery in the six previous weeks
* Nasal swab positivity to Sars-CoV-2
* Need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus
Improving Pneumococcal Vaccination Rates in an Ambulatory Pre-surgical Testing Setting

The purpose of this quality improvement project is to improve the immunization rates of an at-risk adult population seen in an ambulatory healthcare environment, through the use of targeted health education messages regarding pneumococcal immunization. Patients seen in an out-patient pre-surgical testing center will receive 1) a one-page written information sheet that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this message, provided by the clinical staff, during the patient's interview.

At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed" message that emphasizes the benefits of pneumococcal vaccinations. This educational material will be reviewed and reinforced by clinical staff during the assessment phase of the clinical visit. Among this group, there will be increased vaccination rate compared with at-risk adult patients who did not receive this communication (prospective vs retrospective data).

The purpose of this project was to improve the immunization rates of an at-risk adult population seen in an ambulatory environment, through the use of targeted and evidence-based health education messages regarding pneumococcal immunization and staff training on the use of gain-framed messaging.

We hypothesized that there would be an increase in immunization rates for at-risk adults following implementation of the intervention.

The objective of the project was to increase our local immunization rate by 30% (from 20% to 50%) and to provide tools and processes that can be utilized in other ambulatory healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

* Patient seen in out-patient pre-surgical testing center
* At-risk adult patient as defined by the Centers for Disease Control (CDC)

Exclusion Criteria:

* Minors