cyrilzakka/clinical-trials huggingface dataset:
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants

The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of non-childbearing potential.
* Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
* Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
* Able to comply with all study procedures, including the 25-night stay at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria:

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  * liver disease
  * pancreatitis
  * peptic ulcer disease
  * intestinal malabsorption
  * gastric reduction surgery
  * history or presence of clinically significant cardiovascular disease.
* Participants with out-of-range, at-rest vital signs.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee), and Sponsor.
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) through the end of the trial.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
* Receipt of blood products within 2 months prior to Check-in (Day -1).
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), GI, neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)

This study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. The benefit will be evaluated in noisy environments regarding speech intelligibility when the CROS system is adjusted to different microphone settings. Additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the CROS system in combination with smartphone and accessories. This study is a confirmatory study.

Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.

One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so- called CROS transmitter together with a hearing aid.

The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Eligibility Criteria:
Inclusion Criteria:

* hearing impaired adults, with \& w/o hearing aids (experiences)
* good written and spoken (Swiss) German language skills
* ability to fill in a questionnaire conscientiously
* informed consent as documented by signature
* asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
* availability of Smartphone
* availability of TV or Tablet
* ability to operate and handle the investigational device
* ability to describe listening impressions/experiences and the use of the hearing aid
* Ability to produce a reliable hearing test result

Exclusion Criteria:

* Contraindications to the medical device:
* aidable hearing loss on the intended CROS side
* acute tinnitus (in either one ear and occurrence less than three months)
* anatomical deformity of the CROS ear (e.g. absence of the auricle)
* Known hypersensitivity or allergy to materials of the investigational device
* any auricle deformities, that prevents secure placement of the (test) devices
* no willingness to test the investigational device system
* no willingness to test the investigational device system for at least 8h a day
* Hint for psychological problems from investigators point of view
* reported fluctuating hearing that could influence the test result
* reported symptoms of vertigo and dizziness by participants
The Impact of Vitamin D on Tuberculosis Among Koreans

Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on TB development will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* older than 19 years
* diagnosed and treated having a tuberculosis

Exclusion Criteria:

* positive HIV antibody
Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient

In this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. The purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

Patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate poor nutritional status. Recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. The aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated
* Informed consent signed

Exclusion Criteria:

* stage IV, underwent palliative chemotherapy or radiotherapy patient
* clinically significant cardiac or pulmonary disease
* Unable to walk or exercise
A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection

The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.

This is a randomized, patient, investigator and sponsor blinded, placebo-controlled study in pregnant women with primary HCMV infection. The study has three periods: (I) screening (II) double-blinded placebo-controlled treatment and (III) post-delivery follow-up of women and neonates/infants. Pregnant women with confirmed primary HCMV infection will participate in periods I and II. Mothers and neonates/infants born to mothers enrolled in the study will participate in period III.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Pregnant women ≥ 18 years of age with primary HCMV infection occurring between 6 and 24 weeks of gestation
3. Ability to receive study drug within 6 weeks of the presumed onset of primary maternal infection.
4. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Confirmed or suspected fetal HCMV infection, defined as positive HCMV DNA in amniotic fluid or fetal ultrasound abnormalities suggestive of fetal HCMV disease.
2. Prior treatment with any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (\>25 mg/kg/day IV), valacyclovir (\>3 gm/day oral), famciclovir (\>1500 mg/day oral), HCMV immune globulin, immune globulin (\>500 mg/kg), or any other medication with anti-HCMV activity.
3. Any surgical or medical condition (other than pregnancy) which might increase the risk for thrombotic events if the patient is given immune-globulins. These conditions include cryoglobulinemia, monoclonal gammopathies, and hypertriglyceridemia (fasting level \>1000 mg/dL). The investigator should make this determination based on the patient's medical history and laboratory data.
4. History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
5. Patient request for medical interruption or termination of pregnancy before inclusion.
6. Any surgical or medical condition which may jeopardize the patient or fetus in case of participation in the study. The investigator should make this determination in consideration of the patient's obstetrical history.
7. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
8. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
9. Body weight \> 100 kilograms.
Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history \> 2 weeks duration) or malnutrition.

This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history \> 2 weeks duration) or malnutrition (assessed by height-for-age Z-score less than -1). Secondary objectives of the study include determining the effect of 7 days of supplementation of alanyl-glutamine or glycine on diarrhea frequency and duration; weight gain; protein loss and intestinal inflammation, and lactoferrin excretion; and weight gain at 2-4 weeks after treatment. One hundred and eight children who meet the inclusion criteria will be prospectively randomized to one of two treatment groups: (1) Glycine or (2) Alanyl-Glutamine. All children will be given vitamin A and Zinc supplementation; and if they have diarrhea, standard oral or IV rehydration therapy will be administered.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for \> 2 weeks or height-for-age Z-score (HAZ) less than -1, which is the median of HAZ scores in children at HIAS.
2. Be an inpatient and willing to stay for 7 nights at HIAS.
3. Child's parent or guardian must sign informed consent.

Exclusion Criteria:

1. Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
2. Children who participated in the "community study" or any other study within the past two years (Reason: The children in the "community study" will have received glutamine.)
3. Children with suspected other illnesses as indicated by fever \>102 degrees F at time of screening off antipyretics.
4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
5. Severe malnutrition defined as HAZ \<-3.
Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India

The purpose of this study is to describe the effectiveness (overall response rate \[ORR\] and time to progression \[TPP\]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
* CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians

Exclusion Criteria:

- Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
Dapagliflozin Efficacy and Action in NASH

This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged≥18 years;
* Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
* Patients with T2DM at screening had to have stable glycaemic control (HbA1c \<9.5%) .

Exclusion Criteria:

1. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
2. A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
3. Obstructive biliary disease;
4. Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
5. Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
6. Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
7. Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
8. Serum alanine aminotransferase (ALT) greater than 300U/L
9. A history of Type 1 diabetes;
10. A history of bladder cancer;
11. Women who are pregnant or plan to become pregnant;
12. Serious medical disease with likely life expectancy less than 5 years;
13. Patients who cannot be followed for 24 months (due to a health situation or migration);
14. Participation in other clinical trial in the 30 days before randomization;
15. Patients who are unwilling or unable to give informed consent.
Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery

With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia.

The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing foot and ankle surgeries under the care of Dr. Steven Raikin with continuous popliteal blocks at Riverview Surgical Center will be considered for enrollment.

Exclusion Criteria:

* Patients who present with a) known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type,
* Existing use of narcotics,
* Pregnant women,
* Individuals under the age of 18
* Procedures involving any other forms of anesthesia other than general anesthesia with a continuous popliteal nerve block.
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
* Macular edema with average central retinal thickness ≥ 250 µm
* A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
* Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
* Daily prednisone dose \< 1 mg/kg

Exclusion Criteria:

* Patients with choroidal neovascularization.
* Patients with the following forms of uveitis:

  1. Serpiginous choroidopathy
  2. Acute multifocal placoid pigment epitheliopathy
  3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)
* Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
* Patients who had a prior vitrectomy
* Any eye condition that may affect the evaluation of visual acuity and retinal thickness
* Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)
* Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months
* Other protocol-defined inclusion/exclusion criteria may apply
Perioperative Administration of Pregabalin for Pain After Septoplasty

Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Persons who scheduled for elective septoplasty under general anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours postoperatively.

Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Patients will be randomly assigned to one of two groups to receive either pregabalin (Lyrica®, Pfizer, Inc.) or placebo (vitamin complex). According to their assigned study group, patients received either pregabalin (75 mg) or placebo twice, one hour before surgery and 12 hours after the initial dose. The assessment of pain and side effects, such as nausea and vomiting, headache, dizziness, sedation, and blurred vision, were made at one, six, 12, and 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 ≥ and ≤ 65 years
* Patients with nasal packing after septoplasty

Exclusion Criteria:

* previous septal surgery history
* postoperative complications including septal hematoma, bleeding ets.
* Current therapy with pregabalin, gabapentin, or any opioid
* Renal insufficiency
* History of seizure disorder
Electrical Control of Bladder in Spinal Cord Injury Patients

The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R\&D, PVA and a commercial stimulator company.


Eligibility Criteria:
Inclusion Criteria:

Spinal cord injury with bowel \& bladder problems

Exclusion Criteria:
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
3. Be at least 18 years old.

Exclusion Criteria:

1. Be blind (no light perception), have missing or non-functional eyes.
2. Be unable to open their eyes.
3. Have a history of unresolved strabismus, diplopia, amblyopia.
4. Have a history of unresolved cranial nerve III, IV, or VI palsy.
5. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
6. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
7. Have a prior history of unresolved ocular-motor dysfunctions.
8. Have used cannabis, alcohol etc. 24 hours before study commences.
9. Be 100% naïve to cannabis usage.
10. Be pregnant.