cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing KB407 for the Treatment of Cystic Fibrosis

This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions
2. Subjects aged 18 years or older at the time of Informed Consent
3. A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:

   * A historical sweat chloride value \>60 mmol/L
   * Two copies of a disease causing mutation in the CFTR gene
4. Clinically stable in the opinion of the Investigator
5. Percent predicted FEV1 ≥50% and ≤100% of the predicted normal for age, gender, and height at Screening
6. Resting oxygen saturation ≥92% on room air at Screening

Exclusion Criteria:

1. Initiation of any new chronic therapy (eg, CFTR modulator, hypertonic saline, inhaled antibiotic) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to the first dose
2. Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness 14 days prior to the first dose that, in the opinion of the Investigator, may confound study results
3. Treatment for Burkholderia cenocepacia, Burkholderia dolosa, or Nontuberculosis Mycobacteria infection within 3 months prior to the first dose
4. Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to the first dose
5. History of or listed for solid organ transplantation
6. Any condition (including a history or current evidence of substance abuse or dependence, uncontrolled asthma, or is considered to be immunocompromised) that, in the opinion of the Investigator, would impact a subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB407
7. An active oral herpes infection 30 days prior to the first dose
8. Has received a vaccine within 72 hours prior to the first dose or has a planned vaccination during the treatment period
9. Women who are pregnant or nursing
10. Subject who is unwilling to comply with contraception requirements per protocol
11. Clinically significant abnormalities of hematology or chemistry testing at Screening that the Investigator believes may interfere with the assessment of safety and/or efficacy of the study treatment
12. Subject has a known hypersensitivity to inhaled glycerol
13. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
14. Bronchoscopy participants only: Unable to tolerate bronchoscopy procedure and airway sampling, in the opinion of the Investigator
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

The aims of this study are:

* to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
* to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for inclusion in the study if all of the following criteria are met:

1. Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:

   * Gleason 3 + 3 prostate adenocarcinoma as a maximum,
   * Two (2) to three (3) cores positive for cancer
   * A maximum cancer core length of 5 mm in any core.
2. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)
3. Serum prostate specific antigen (PSA) of 10 ng/mL or less
4. Prostate volume equal or greater than 25 cc and less than 70 cc.
5. Male subjects aged 18 years or older.

Exclusion Criteria:

Subjects will not be eligible for the study if meeting any of the following criteria:

1. Unwillingness to accept randomisation to either of the two arms of the study
2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
3. Any surgical intervention for benign prostatic hypertrophy
4. Life expectancy less than 10 years.
5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
7. Subject unable to understand the patient's information document, to give consent or complete the study tasks.
8. Subject in custody and or in residence in a nursing home or rehabilitation facility
9. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis)
10. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.
Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).

This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF \[NCT00103662\]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).

Eligibility Criteria:
Inclusion Criteria:

* All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)

Exclusion Criteria:

* No Exclusion Criteria
Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss

* To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL).
* To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL.

Sudden sensory neural hearing loss (SSNHL) is defined as sensorineural hearing loss of at least 30 dB over 3 consecutive frequencies within 3 days. Different treatment modalities have been used in treatment of SSNHL including systemic corticosteroids alone or in combination with vasodilators as pentoxifylline and hydroxyethylstarch (HES) or low molecular weight dextran, hyperbaric oxygen therapy \& plasmapheresis.

Intratympanic (IT) dexamethasone application has shown significantly higher perilymph steroid concentrations with lower systemic concentrations, thus avoiding the side effects associated with the systemic route. It has been used with varying results for the treatment of Meniere's disease, SSNHL, low frequency hearing loss and tinnitus. After IT injection, the drug concentration in the inner ear depends on the drug being in contact with the round window membrane (RWM), absorbing it from the middle ear into the inner ear. However, large amount of the injected drugs are either absorbed by the middle ear mucosa or evacuated via the eustachian tube.

It has been postulated that combining the drug with a biodegradable material will prolong its availability in the middle ear and/or aid its diffusion across the RWM. Between these materials, Hyaluronic acid (HA) is a natural product normally present is humans' perilymph in small amounts along with many other tissues throughout the body. Several postulations have been given to HA mechanism of action in drug delivery in the middle ear either by its osmotic effect on the perilymph, modulating RWM permeability or altering blood viscosity thus increasing blood and oxygen delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged 18 and over)
2. Patients with sudden sensory neural hearing loss (SSNHL)

Exclusion Criteria:

1. Patients with middle or external ear pathology.
2. Patient with history of traumatic skull base fracture.
3. Patients with previous ear surgery.
4. Patients with other neurological symptoms or signs (Other cranial nerves affection).
Effect of Neurostimulator Usage on Block Success

The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block


Eligibility Criteria:
Inclusion Criteria:

* Class I, II and III of American Society of Anesthesiologists (ASA) classification
* being between 18 and 80 years of age,
* body mass index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

* Patients who did not give consent,
* were above ASA III,
* pregnant,
* had a neuromuscular disease,
* bleeding diathesis,
* a local anesthetic allergy,
* an infection in the area where nerve block would be applied, and
* had previously operated from the infraclavicular fossa were not included in the study
Myasthenia Gravis Inebilizumab Trial

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 230 participants (188 acetylcholine receptor antibody positive \[AChR-Ab+\] and 42 muscle-specific tyrosine kinase antibody positive \[MuSK-Ab+\]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with \> 50% of this score attributed to non-ocular items, or an MG-ADL score \>=11, Quantitative Myasthenia Gravis (QMG) score \>= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.

Study acquired from Horizon in 2023.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MG with anti-AChR or anti-MuSK antibody.
2. MGFA Clinical Classification Class II, III, or IV.
3. MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
4. QMG score of 11 or greater.
5. Participants must be on:

   1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
   2. One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
   3. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.

Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.

Exclusion Criteria:

1. Receipt of the following medications within the 4 weeks prior to Day 1:

   1. Cyclosporine (except eye drops)
   2. Tacrolimus (except topical)
   3. Methotrexate
2. Current use of:

   1. Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
   2. Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
   3. Azathioprine \> 3 mg/kilogram (kg)/day
   4. Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day
   5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
Stress Hormones, Mood and Women's Sexual Desire (MODEST)

Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although DHEA is a precursor of testosterone it has other actions including involvement in the stress system. It is also linked to mood. This study focuses on measures of childhood stress, current mood and salivary stress hormones, in women with and without HSDD. We hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system involving the brain, pituitary and adrenal glands where DHEA is produced.


Eligibility Criteria:
Inclusion Criteria for HSDD Group:

* (1) diagnosis of HSDD
* (2) over 19 years of age
* (3) sexual complaints of low desire of at least 12 months duration.

Inclusion criteria for Control group:

* (1) sexually healthy, i.e., must not meet criteria for any sexual dysfunction, as determined by a telephone screening, followed by an in-person structured assessment, the Decreased Sexual Desire Screener (DSDS)
* (2) over 19 years of age.

Exclusion Criteria for both Control and HSDD groups:

* (1) lack of fluency in English
* (2) currently meeting DSM-IV-TR diagnostic criteria for major depressive disorder as measured by an in-person, semi-structured interview based on the Major Depressive Disorder Module of the Structured Clinical Interview for DSM-IV-TR (SCID-I
* (3) current use of prescription drugs such as antidepressants or other medications with known sexual side effects (e.g., glucocorticoids, aromatase inhibitors), or known effects on cortisol metabolism, or use of illicit drugs
* (4) use of hormone replacement therapy or hormonal contraceptives;
* (5) a body mass index (BMI) \<18.5 or \>29.9
* (6) cigarette smoking
* (7) chronic medical or psychiatric disease with potential to interfere with sexual function (e.g., chronic neurological disease, cardiac and liver disease, eating disorders, anxiety disorders)
* (8) chronic pain with intercourse not relieved by a vaginal lubricant
* (9) loss of genital responsiveness
* (10) significant relationship discord
* (11) not having a family physician who we could contact if depression is diagnosed during the assessment
* (12) difficulty in complying with questionnaires or in completing interview.
Genetic Risk Assessment of Defibrillator Events

Arrhythmias remain a major health problem, causing at least 250,000 deaths annually in the United States. Pharmacological treatments often do more harm than good, and device therapies are limited by high cost and effects on quality of life. Ion channel mutations cause rare inherited arrhythmopathies, but account for only a small fraction of patients with life- threatening arrhythmias and sudden death. Most arrhythmias occur during myocardial ischemia, following myocardial infarction, and in patients with poor left ventricular (LV) function of any etiology. Aside from ejection fraction (EF), few clinically useful indicators to stratify the risk of sudden death have been identified. The role of subtle difference in ion channel expression and/or structure in predisposing patients to arrhythmias and modulating the risk of sudden death is unknown.

In this study, we are prospectively testing whether polymorphisms in ion channels and ion channel modifying genes are associated with arrhythmias in a population with internal cardioverter-defibrillators (ICDs) and poor LV function. We will test the hypothesis that functional polymorphisms in the coding sequences and promoter regions of cardiac genes (e.g. ion channels, beta-adrenergic receptors) predispose individuals to arrhythmias and /or heart failure progression.

We hope to identify genetic predictors for the common forms of sudden cardiac death. This would allow the identification of a subpopulation of heart failure patients that would benefit most from ICD placement.


Eligibility Criteria:
Inclusion Criteria:

* An ICD placed during the last 5 years, or a planned ICD within 1 month
* Age 18 or older
* Left Ventricular Ejection fraction \< or = 30%
* Ability to give informed consent

Exclusion Criteria:

* Patient refuses or is unable to give consent
* A life expectancy \<6 months from a non-cardiac life threatening disease
* Ongoing Class IV heart failure symptoms despite treatment
* History of cardiac transplant or left ventricular assist device
Tracking Breathing During Sleep With Non-contact Sensors

The purpose of this study is to evaluate the feasibility of tracking breathing during sleep with non-contact sensors (for example, microphones or wireless movement sensors). The investigators will use the data collected with these sensors to develop algorithms for tracking breathing during sleep. The investigators will assess the performance of the algorithms by comparing automatic output against manually-generated labels.

Subjects will be asked to place non-contact sensors (for example, ambient microphones, wireless movement sensors) in their home sleep environment. No sensors will be attached to or otherwise in contact with the subject's body. The subjects will start the data collection before they fall asleep, and stop the data collection the next morning when they wake. The subjects will then return the sensors to the investigator for analysis.

The investigators will study the data and associated manual labeling. The investigators will develop algorithms that use statistical and machine-learning methods to train computer models designed to track breathing automatically. The investigators will compare the automatic output against manually generated labels to determine breath-tracking accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-89
* No self-reported sleep breathing problems

Exclusion Criteria:

* Positive diagnosis for sleep breathing problem (e.g., obstructive sleep apnea)
Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

Eligibility Criteria:
Inclusion Criteria:

* Verified medical history of overactive bladder for at least 6 months
* Capable of walking unassisted to use the bathroom
* Able to measure voided urine volume and complete the diary without assistance
* If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study

Exclusion Criteria:

* Diagnosis of a neurological disease affecting bladder function
* Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula
* History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume \> 150 mL
* Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more
* Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis
* Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years
* Myasthenia gravis
* Angle closure glaucoma
* Current implantation of interstim electrodes or vaginal surgical mesh
* Presence of a clinically significant medical condition at any time during the study
* Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
* Participated in an investigational drug trial within 3 months of screening
Decrease of Recurrent Pancreatitis

Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.


Eligibility Criteria:
Inclusion Criteria:

* Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital

Exclusion Criteria:

* Other etiologies of pancreatitis besides alcohol
* Uncertain diagnosis
* Recurrent disease
* Refusal