cyrilzakka/clinical-trials huggingface dataset:
OTO-201 for the Treatment of Otitis Externa

This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 80 years, inclusive
* Subject has a clinical diagnosis of unilateral otitis externa
* Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has tympanic membrane perforation
* Subject has a history of known immunodeficiency disease
* Subject has fungal otitis externa, based on clinical signs
Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old ASA I-II patients
* Clinical diagnosis of gastroesophageal reflux patients

Exclusion Criteria:

* Allergic reactions to NSAIDs or opioid analgesics
* Body mass index exceeding 35
* Pregnancy
Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda

Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries

Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood

Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

This study has been set up as part of the response to the international outbreak of the novel Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The aim of the study is to answer important questions about the impact of the novel coronavirus on pregnant women and their infants. The investigators aim to describe the sero-epidemiology and burden of COVID-19 disease among pregnant women, as well as the impact on maternal and neonatal health, by collecting epidemiological data and by collecting samples during pregnancy, labour and delivery and in the neonatal period.

Data from this study will be pooled from 5 countries; Malawi, Uganda, Mozambique, the Gambia, and Kenya to provide robust and generalisable evidence from the different regions in sub-Saharan Africa. the investigators hope that with this information, they can contribute to the evidence base for recommendations, guidance and policy decisions for the clinical management and public health response to protect pregnant women and their infants.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman or emancipated minor at any gestation, up to and including day of delivery. Individual study sites may have their own specific inclusion/exclusion criteria which is not listed here.
* Accepts to read or to be read to and sign or fingerprint the approved study consent form
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available.

This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies.

The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

A protocol amendment in May 2016 created two parts to this trial: Part A (the extended treatment period) and Part B (the safety treatment period), whose objectives are as follows:

Primary Part A: To evaluate the efficacy of Cannabidiol Oral Solution in treating refractory infantile spasms (IS).

Secondary:

Part A:

* To evaluate the safety of Cannabidiol Oral Solution in treating refractory infantile spasms.

Part B:

* To assess the long-term safety of Cannabidiol Oral Solution as an adjunctive treatment for subjects with Infantile Spasms (IS)
* To establish the continued efficacy of Cannabidiol Oral Solution in maintaining seizure control in subjects with IS
* To assess the global status of subjects taking Cannabidiol Oral Solution for an extended period of time determined by various qualitative assessments
* To monitor for changes in plasma levels of Cannabidiol Oral Solution during long-term treatment of subjects with IS

Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification, including infantile spasms
* Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the Investigator and study coordinator.

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the analysis of results
* During the Safety Treatment and Follow-up Periods, subjects are not to receive the following:

  1. any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or marijuana)
  2. any other investigational drug or investigational device
Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years
* Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary and/or musculoskeletal disease; glaucoma; a psychiatric disorder or any other chronic disease, whether controlled by medication or not.
Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1), a Topical Ophthalmic Drug for Presbyopia

A study to establish safety, tolerability, and efficacy of PresbiDrops (CSF-1) in presbyopic subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women between 40 and 65 years of age (inclusive).
2. Subjects who provide written informed consent to participate in the study.
3. Subjects have signs of presbyopia upon ophthalmic examination.
4. Subjects have normal presbyopia with low distance refraction (sphere no greater than ±0.75 diopter cylinder no greater than ±0.75 diopter cylinder \[DC\], refraction along any principal meridian no greater than 1.00 diopter).
5. Subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is \> +1.00 diopter.
6. Subjects in general good health in the opinion of the Investigator as determined by medical history.
7. Women with childbearing potential must have a negative urine pregnancy test at Screening and be willing and able to use a medically acceptable method of birth control or they must be postmenopausal. Acceptable methods of birth control in this study include: Vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device (IUD), hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
8. Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.

Exclusion Criteria:

1. History of macular disease or any other ocular conditions or congenital malformation.
2. Any medical condition known to affect the structure of the uvea, cornea, lens, or retina or main function of the eyes.
3. No cataract or minimal nuclear sclerosis.
4. Severe dry eye.
5. Any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before the Screening visit.
6. Contact lenses for the past three months before the Screening visit.
7. A difference of more than 0.50 diopter between the manifest spherical equivalent and the wave front refraction spherical equivalent.
8. Pupil size less than 2,5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the Baseline visit.
9. A history of herpes (of any kind) in either eye.
10. Cataract surgery and/or refractive surgery in either eye.
11. Known contraindication, hypersensitivity, and/or allergy to any study drugs or excipients.
12. Any acute illness (eg, acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator.
13. Participation in another clinical trial with drugs received within 30 days of Screening.
14. Pregnant or currently lactating women.
Attention Training for Learning Enhancement and Resilience Trial

Healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. The long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related problems with independent functional abilities. This study aims to understand how the experimental computer program can affect cognition and attention in participants with age-related cognitive decline.

Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at the participant's convenience (the recommended time commitment is 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 65 years of age or older
* Participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments
* Participants must be fluent English speakers
* Participants must have adequate visual, auditory, and motor capacity to use computerized intervention

Exclusion Criteria:

* Participants with diagnosis of PTSD, depression or other psychologically diagnosable emotional disorder
* Participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), HIV/AIDS will be excluded
* Participants enrolled in another concurrent research study will be excluded
* Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded
* Participants with a current or significant past history of substance abuse will be excluded
* Participants who show signs of suicidal ideations or behaviors will be excluded and referred for appropriate treatment
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock

Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients.

While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO.

The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.

This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record.

Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Assistance with VA ECMO

Exclusion Criteria:

* Opposition to the use of data.
* Persons under legal protection (curators, guardianship), judicially safeguarded.
* VA ECMO for refractory cardiac arrest.
Bioequivalence of Two Different Capsule Types of Dabigatran

The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Age =21 and = 55 years
3. Body Mass Index (BMI) =18.5 and BMI = 29.9 kg/m\^2
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Clinically relevant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug
3. Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
4. Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy in particular to study drug or its excipients) which is deemed relevant to the trial as judged by the investigator
8. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
9. Alcohol abuse (more than 20 g/day)
10. Drug abuse
11. Any laboratory value outside the reference range that is of clinical relevance (especially hemoglobin, thrombocytes, prothrombin time (PT) and Activated Partial Thromboplastin Time (Measure of the clotting time) (aPTT) or positive drug or virus screening
12. Planned surgeries within four weeks following the end-of study examination
13. Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding within 14 days before or after end-of study examination
Chlorhexidine Lavage for Recurrent Urinary Tract Infection

A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.

There is a critical need for low-cost, non-antibiotic interventions that are feasible for patients to utilize for risk reduction and prevention of recurrent urinary tract infections (UTIs). The current most effective non-antibiotic prophylaxis for recurrent UTI is vaginal estrogen; however, approximately 50% of women will continue to experience UTIs. The investigators propose a randomized control trial of postmenopausal women on vaginal estrogen with the diagnosis of recurrent UTIs to evaluate a novel post-defecation hygienic strategy utilizing a 2% chlorhexidine perineal lavage. Participants will be randomized to either a 2% chlorhexidine perineal lavage or a water lavage. Study participants will be followed for up to 6-months, and UTIs will be tracked with culture proven samples throughout study participation.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal female between age 55 and 89
* No post-menopausal bleeding
* Diagnosis of recurrent urinary tract infection (UTI) in the electronic health record or as two culture proven UTIs in 6 months or three culture proven UTIs in 12 months
* At least one UTI in the 6 months prior to entering the study
* Asymptomatic for UTI symptoms at the time of enrollment.
* On vaginal estrogen therapy for at least 6 weeks prior to enrollment
* Ready access to email and internet

Exclusion Criteria:

* Recent prophylactic antibiotic use (washout period of 4 weeks)
* Neurogenic bladder
* Diagnosis of urinary retention
* Uncorrected Stage III-IV prolapse
* Indwelling catheter or need for intermittent self-catheterization
* History of complicated UTIs
* History of interstitial cystitis or bladder pain syndrome
* History of fecal incontinence/accidental bowel leakage
* Greater than 14 bowel movements per week
* Non-English speaking
* Allergy to chlorhexidine gluconate
* Inability to utilize vaginal estrogen therapy
* Recent urogynecological or urologic surgery (\<12 weeks)
Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma

The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is associated with significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. Hence, for safety reasons, patients frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose) dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher (three-weekly) dosing frequency.

Eligibility Criteria:
Inclusion Criteria:

* Age at or above 21 years
* Clinical diagnosis of MM
* Active MM with measurable disease
* Signed written informed consent
* Signed consent for drug safety program for thalidomide

Exclusion Criteria:

* Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Patients with Indolent MM (IMM), or Smouldering MM (SMM)
* Known hypersensitivity (including severe cutaneous reactions) to d, t or Z
* Fulminant sepsis
* Females in the reproductive age group who refuse contraception
* Pregnancy
* 24 hr urinary creatinine clearance time (CCT) \<30 ml/min
* Previous renal transplantation
* Severe peripheral neuropathy
* Recurrent DVT or PE
* Severe arrhythmias and cardiac conduction disorders
* Liver dysfunction of active viral hepatitis
* Osteonecrosis of the jaws (ONJ)