cyrilzakka/clinical-trials huggingface dataset:
A Study of Oral Hymecromone and Hyaluronan Synthesis

The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate.

This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-65 years of age
* Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam
* BMI between 18.5 - 30 kg/m2
* Taking no medications for at least 1 week before and during study enrollment, including drugs of abuse, prescription or OTC medications
* Male subjects who are heterosexually active must use an acceptable method of contraception (abstinence, condom with or without spermicidal agent, or partner contraceptive use as described in requirements for female subjects) to avoid pregnancy in their partner for the entire study period
* Female subjects who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
* Be able to provide written informed consent and comply with requirements of the study
* Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
* Be able to read, speak and understand English
* Able and willing to understand the study, adhere to all study procedures, and provide written informed consent

Exclusion Criteria:

* Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia
* Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
* Subjects with liver failure or LFTs above the upper limit of normal
* Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician
* Subjects with a baseline corrected Fridericia's QT interval (QTcF) \>450ms and a baseline ECG abnormalities which in the opinion of the study physician, is clinically significant
* Subjects with ongoing alcohol or illegal drug use
* Subjects who are pregnant, lactating or attempting to conceive
* Known allergy to hymecromone or any component thereof
* Physician concern that participant may not adhere to the study protocol
* Current participation in another clinical trial
Synergistic Effect of Plasmid Inhibitors and Antimicrobial Drugs Against Clinical MDR-hvKP

1. Screening for MDR-hvKP causing VAP in patients admitted to chest ICU in Assiut University Hospital.
2. In vitro evaluation of the synergistic activity of combined meropenem/levofloxacin with and without kasugamycin against clinical MDR-hvKP isolates by checkerboard and time killing assay.
3. In vivo evaluation of the synergistic activity of combined meropenem/levofloxacin with and without kasugamycin using MDR-hvKP septic rat model.

New "hypervirulent" Klebsiella-pneumoniae (hvKp) strain has emerged as a clinically-significant-pathogen in both healthy and immunocompromised individuals . HvKp, at its discovery, was rarely resistant to antimicrobial-agents , however, nowadays, antibiotic-resistant hvKP isolates are being reported .

Plasmids are important vectors that bacteria use to transfer resistance and virulence determinants. Typically, genetic elements conferring resistance and virulence were encoded by different plasmids . Most recently, clinicians have been faced, the confluence of resistance and virulence-determinants on the same or coexisting-plasmids with the evolution of multidrug-resistant (MDR) and hypervirulent Klebsiella pneumoniae hvKP .

One approach to combat MDR infections is to combine antimicrobial drugs during a treatment-regimen . Fluoroquinolone plus carbapenems is one of-the most useful-combination used in cases which suffer from MDR to most available monotherapies . Another-approach is Plasmid curing, using plasmid inhibitors, which is the method of removing plasmids from the bacterial populations while leaving the population intact leading to reversal of the plasmid-mediated antibiotic resistance .

Kasugamycin, an-aminoglycoside; is a compound exhibiting significant-antiplasmid activity-up-to-complete suppression of plasmid-replication . Kasugamycin was found to block plasmid replication by inhibiting-expression of plasmid replication initiation-protein, RepE, and to reduce plasmid-levels by 90% . Accordingly, we hypothesize that, using dual-antibiotics supplemented with plasmid inhibitor will be efficient in inhibiting MDR-hvKP, both in vitro and in vivo.

This is the first-study to evaluate the effect of addition of plasmid inhibitor on improving the efficacy of antibiotics and improve their synergistic activity. The results of this study will open the door for-using plasmid-inhibitor-compounds on restoring the usefulness of many conventional-antibiotics to which-resistance has emerged.

Eligibility Criteria:
Inclusion Criteria:

VAP patients (patients under mechanical ventilation for more than 48 h with new or progressive infiltrate on chest X-ray and have at least two of the following criteria:

1. Fever (\>38 oC) with no other recognized cause
2. WBCs \< 4000/mm3 or \>12000/mm3
3. New onset of purulent sputum.
4. Increase in respiratory secretion or increased need for suctioning.
5. New-onset or worsening cough, or dyspnea, or tachypnea worsening gas exchange.

Exclusion Criteria:

Patients with chest diseases other than VAP .
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.

Patients follow the fully standard sleep test according to the normal procedure. This means that they undergo a polysomnography and fill in a questionnaire. If according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. If the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. If the patient agrees, the CPAP-therapy will be started as usual, simultaneously with CGT-i. The latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. Because of the design of this study (starting CGT-I as soon as possible after the diagnosis of OSAS) and the groups already planned for CBT-I, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. The patient comes for monitoring at set times.


Eligibility Criteria:
Inclusion Criteria:

* All patients, male and female, with an OSAS diagnosed by full polysomnography and insomnia diagnosed by questionnaires.
* Age between 18 and 75 years
* Dutch as native language

Exclusion Criteria:

* Patients younger than 18 years and older than 75 years
* Patients with a burn-out
* Patients with restless legs
* Pregnant woman
* Patients who work as shift workers
* Patients with severe psychiatric disorder
* Patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy
* Patients with daily alcohol abuse (men \> 3 drinks on any day or 14 per week, women \> 2 drinks on any day or 7 per week)
A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass

The goal of the trial is to measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment with Verapamil.

The VER-A-T1D (Verapamil SR in adults with Type 1 Diabetes) study is an intervention study within the INNODIA project (an Innovative Medicines Initiative consortium (IMI-2), established through Horizon 2020 initiative of the European Union, involving academic, industry and charitable partners).

In the VER-A-T1D study, the effects of treatment of newly diagnosed patients with T1D with Verapamil will be evaluated. Verapamil appears to protect beta cell function, an effect that could in part be caused by protection against beta cell apoptosis. GLP-1 receptors are expressed in high densities in beta cells. Exendin, a GLP-1 receptor agonist, can be labeled with radionuclides and thus be utilized for visualization of beta cells in vivo by positron emission tomography (PET). This technology has been demonstrated to deliver quantitative information of the radiotracer uptake in the pancreas demonstrating a linear correlation with beta cell mass. In VER-A-T1D, we propose to measure beta cell mass at the time points of inclusion and at evaluation after 12 months. If verapamil protects beta cells against apoptosis, we expect that the uptake of the radiotracer will be higher at 12 months in comparison to the first measurement in the treatment group. The study will be a substudy to VER-A-T1D.

Eligibility Criteria:
Inclusion Criteria:

* • Have given written informed consent
* • Age ≥18 and \<45 at consent
* • Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin
* injection)
* • Must have at least one or more diabetes-related autoantibodies present at screening
* • Must have random C-peptide levels ≥200 pmol/L measured at screening
* • Be willing to comply with intensive diabetes management

Exclusion Criteria:

* Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of VER-A-T1D)
* Renal disease defined as MDRD \<40 ml/min/1.73 m2
* Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.
Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).

The aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. The first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.

Eligibility Criteria:
Inclusion criteria:

* Adult subjects
* Normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order.

The targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss.

Exclusion criteria:

* Children
* Subjects in whom the ossicle chain is missing or incomplete
* Missing informed consent form
* Incapacitated subjects or subjects with impaired judgment capability.
Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10 million people in the US. To understand the clear etiology and mechanism of carpal tunnel syndrome, the measurement of median nerve intraneural blood flow needs to be further scrutinized as the common fluctuating physiological conditions and functional hand activities might contribute to the fluctuation of the measurement and serve as measurement error. This study aims to examine how intraneural blood flow within the median nerve is affected by physiological factors (i.e., body temperature and blood pressure) and functional hand activities (i.e., typing, using a mouse, and cooking).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65
* English-speaking
* Ability to endure a moderate-intensity physical activity
* Ability to type without looking at the keyboard

Exclusion Criteria:

* Pain, tingling, or numbness in the hand or wrist region within the past week
* History of corticoid injection in the upper extremity
* History of surgery in the wrist region
* Carpal tunnel syndrome
* Amyotrophic lateral sclerosis
* Diabetes
* Hypothyroidism
* Pregnant
* Positive Phalen's test
* Persistent median artery within wrist region
* Bifid median nerve
A Sleep Hygiene-based Intervention Program for Infants and Toddlers

Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.

Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton infant born at gestational age \>= 37 weeks

Exclusion Criteria:

* Infants born before 37 weeks gestation
* Infants born with a congenital abnormality or a genetic disorder
* Parents with insufficient Chinese
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology

This study aims to investigate the effect of the formation of social networks using smartphones can help increase physical activity and reduce stress in survivors after breast cancer treatment surgery.


Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III breast cancer
* ECOG Performance Status 0
* Patient who underwent surgery for breast cancer
* Patients with their own smartphones and who can use smartphone apps

Exclusion Criteria:

* Breast cancer recurrence or metastasis
* Severe medical illness
* need to Adjubant Chemotherapy
Comparison of Virtual Reality to Tablet-based Distraction in Children

The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

After receiving IRB approval from our institution and consent from parents or guardians, ASA I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were recruited for this study. They were assigned to either tablet- or VR-based groups. At our institution, tablet-based distraction is widely used and represents standard practice. Children in this control group were given tablets in the preoperative holding area before transport to the operating room. Content consisted of entertainment apps providing access to music videos, movies and games targeting various age groups.

The study group was given a Virtual Reality Smartphone headset in the preoperative holding area prior to transport to the operating room. This headset was chosen because of its low cost and wide compatibility for a variety of smartphones. The content consisted of several VR environments that the child/parent could choose from.

In both groups, the distraction with tablet or VR was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. Anxiety at time of separation was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was determined by using the Mask Acceptance Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-10 years of age
* Undergoing procedure that requires general anesthesia

Exclusion Criteria:

* Emergent procedure
* ASA III-IV
* Patients with facial skin lesions
* Patients with significant history of motion sickness
* Visually impaired patients
* Patients unable to wear a virtual reality headset
* Patients receiving pharmacological intervention to decrease preoperative anxiety
Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer

Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety lead-in.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of a gastrointestinal, abdominal, or pelvic cancer for which the use of continuous definitive or adjuvant external-beam RT to the abdomen or pelvis to a minimum dose of 4500 cGy is planned.
* Scheduled to receive concurrent administration of fluoropyrimidine chemotherapy (5-FU or capecitabine) during radiation therapy.
* Age ≥ 18 years.
* Life expectancy ≥ 6 months.
* Negative pregnancy test done ≤7 days prior to registration (for women of childbearing potential only).
* The following laboratory values obtained ≤ 28 days prior to registration:

  * Hemoglobin ≥ 9.0 g/dL
  * WBC ≥ 3,500
  * Absolute neutrophil count ≥ 1,500
  * Platelets ≥ 100,000
* ECOG Performance Status (PS) of 0, 1, or 2.
* Willingness to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment.
* Ability to complete questionnaire(s) alone or with assistance.
* Ability to understand and willingness to sign informed consent.

Exclusion Criteria:

* Previous bowel resection which, in the opinion of the investigator, would decrease the benefit of the probiotic. Patients who have undergone recent bowel surgeries which would not decrease the benefit of the probiotic are eligible provided they are more than 30 days from surgery with no serious complications.
* Known allergy to a probiotic preparation.
* Any history of inflammatory bowel disease.
* Grade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool ≤7 days prior to registration.
* Any medical condition that may interfere with ability to receive protocol treatment.
* Prior abdominal or pelvic RT.
* Use of probiotics ≤ 2 weeks prior to registration.
* Use of antibiotics ≤ 3 days prior to registration.
* Planned continuous antibiotic treatment during RT.
* History of gastrointestinal or genitourinary obstruction or porphyria.
* History of irritable bowel syndrome (IBS).
* History of hypersensitivity to all of the following antibiotics: penicillin, erythromycin, clindamycin, and any fluoroquinolone.
Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cyclophosphamide plus peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the toxicity of autologous peripheral blood stem cell transplantation following involved field radiotherapy, high dose cyclophosphamide, and total body irradiation in patients with recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma. II. Determine the response in patients treated with this regimen.

OUTLINE: Patients undergo involved field radiotherapy on days -16 to -7. Patients receive cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo total body irradiation twice daily on days -4 to -1. Autologous peripheral blood stem cells are reinfused on day 0. Patients are followed every month for 1 year.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease or non-Hodgkin's lymphoma that is refractory to standard therapy or has relapsed following initial response Eligible non-Hodgkin's lymphoma: Low grade Intermediate grade Immunoblastic large cell lymphoma (high grade) Eligible for involved field radiotherapy, cyclophosphamide, and total body irradiation No CNS non-Hodgkin's lymphoma or Hodgkin's disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Physiologic age 65 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min if creatinine 1.5-2 mg/dL Cardiovascular: No active heart disease (congestive heart failure, history of myocardial infarction within the past 3 months, or significant arrhythmia) requiring medication Pulmonary: No nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude intensive chemotherapy DLCO at least 50% predicted\* FEV1 and/or FVC at least 75% predicted\* \* Unless due to underlying lymphoma or Hodgkin's disease Other: No other concurrent medical condition that would preclude aggressive cytotoxic chemotherapy HIV negative No clinical evidence of AIDS

PRIOR CONCURRENT THERAPY: See Disease Characteristics