cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069

Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069

The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of AZD5069 given twice daily for 3 days

Eligibility Criteria:
Inclusion Criteria:

* 1.Provision of signed and dated, written informed consent prior to any study specific procedures.
* 2.Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG and performed before first dose administration.).
* 3.Healthy volunteers should have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).

Exclusion Criteria:

1. Pyrexial with a body temperature higher than 37.7°C at Day -1 (Visit 2), or as judged by the investigator.
2. Screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (Visit 1).
3. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in the previous 90 days, or history of skin abscesses within the previous 90 days.
4. Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (Visit 1), as determined by the investigator.
Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial

It is known that alcohol consumption can lead to cognitive impairment and dysregulation of inflammatory responses. A preliminary randomized controlled trial conducted by our research team has suggested that nitrate may improve cognition in hospitalized patients with alcohol dependence. To further expand the population and applicability, this study aims to explore the effects of nitrate on cognition in a real-world population of heavy drinkers. The researchers have designed a two-stage clinical trial: the first stage involves the analysis of existing data, and the second stage will recruit 43-54 new participants for a 14-day dietary inorganic nitrate (nitrate-rich beetroot juice, \~750 mg NO3- /d) intervention.

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Eligibility Criteria:
Inclusion Criteria:

A. Individuals with a history of heavy alcohol consumption (as defined below), who have continued heavy drinking within the past week and have no plans to quit drinking within the next month.

B. Individuals with a history of heavy alcohol consumption who are currently hospitalized due to alcohol dependence or alcohol use disorder, and are still undergoing treatment.

The CDC (Centers for Disease Control and Prevention) defines heavy alcohol consumption as follows: For males: more than 15 standard alcoholic drinks per week. For females: more than 8 standard alcoholic drinks per week. Here, one standard drink unit is approximately 14 grams of pure alcohol- C. A Montreal Cognitive Assessment (MoCA) score greater than 13.

Exclusion Criteria:

A. Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.

C. Individuals who are allergic to any substances used in the trial, such as beets.
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years of age
* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

(There are additional inclusion criteria)

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)
Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman

In this study at least 24 sportswoman (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress.

In this study at least 24 sportswoman (18-50 years old) with pelvic floow symptos (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. They should havo no children, other relevant systemic disorders and assume no drugs. They should practice sports by at least one year.

one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress. In partiqular they fill in:

* Pelvic Floor Distress Inventory (PFDI-20)
* Incontinence Severity Index (ISI)
* Quality of life questionnaire (SF-36)
* King's Health Questionnaire (KHQ)
* Intestinal related symptoms questionnaire (ICIQ-B)
* Depression Anxiety Stress Scale (DASS-21)

Eligibility Criteria:
Inclusion Criteria:

* practicing sports by at least one year

Exclusion Criteria:

* no systemic disorders
* no drugs assumption
* no children
Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)

This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.

Ureteroscopic stone treatment is a minimally invasive procedure commonly performed for kidney stones. Recently, the thulium fiber laser (TFL) has demonstrated effectiveness in this procedure. A new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG. Moreover, the p-Tm:YAG laser has been shown to be effective in treating a wide range of human stone types. The Dornier Thulio p-Tm:YAG laser has been tested clinically in a limited fashion via pilot studies in URS and the RevoLix Hybrid Thulium Laset (HTL) was studied in mini-PCNL. However, limited research has directly compared its efficacy and safety and no prospective comparative trials have been published.

This study aims to investigate whether Dornier Thulio p-Tm:YAG laser is non-inferior to TFL in terms of dusting ablation efficiency (J/mm3) and dusting ablation speed (mm3/s) for ureteroscopic stone treatment. To our knowledge no large-scale study has examined the outcomes of p-Tm:YAG compared to TFL for the treatment of kidney stones which warrants an investigation giving the promising results previously reported.

The primary objective is to assess stone dusting ablation efficiency (Joules/stone volume ablated) between both laser systems in vivo for ureteroscopic stone treatment . Secondary objectives include assessing stone dusting ablation speed (stone volume ablated/lasing time) and complication profile of both laser systems.

The investigators hypothesize that dusting ablation efficiency and speed of the p-Tm:YAG laser will be non-inferior to TFL for the treatment of renal stones totaling 7-20 mm in diameter with similar clinical and safety/complication outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
* Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
* Must be able to give consent
* Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study
* Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology

Exclusion Criteria:

* Concomitant stones in the ureter
* Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
* Prior radiotherapy to the abdomen or pelvis
* Neurogenic bladder or spinal cord injury
* Pregnancy
* Untreated UTI
Head Position on Preventing Emergence Cough

The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.

During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.

Eligibility Criteria:
Inclusion Criteria:

* Operation schedule of laparoscopic cholecystectomy
* Must be performed under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2
* Respiratory infection
* Uncontrolled hypertension
Impact of Nonsurgical Periodontal Therapy on Oral Health Related Quality of Life

Periodontitis is a destructive inflammatory disease of tooth supporting tissues and it adversely affects oral and general health as well as lowering the quality of life. Nonsurgical periodontal therapy is a gold standard technique for treating mild to moderate periodontitis and it was reported to significantly improve oral health related quality of life.

Periodontitis is a chronic disease characterized by progressive loss of tooth-supporting tissues. It is adversely affecting function, esthetic, and general wellbeing. Oral health related quality of life (OHRQoL) is the part of quality of life which is affected by oral cavity-related status. Majority of clinical studies emphasize on periodontal outcomes after periodontal therapy. However, tangible outcomes perceived by the patient such as need for re-treatment, tooth survival, and OHRQoL are mostly neglected. OHRQoL is mainly measured by using self-reported questionnaires and the most commonly used one is Oral Health Impact Profile (OHIP).

Nonsurgical periodontal therapy (NSPT) is the gold-standard technique for treating shallow to moderately deep periodontal pockets. The principle of this technique is based on mechanically disrupting subgingival dysbiotic biofilm, consequently; restoring homeostasis and healthy state of periodontal tissues. Indeed, halting progressive periodontitis is a major contributor for improving oral health and increasing tooth survival rate which are positively perceived by the patients. Previous studies consistently reporting improvement of OHRQoL following periodontal treatment. Therefore, this study aimed to investigate the impact of NSPT on OHRQoL for Stage (S)2 and S3 periodontitis patient and the factors predicting the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Not reporting history of any systemic disease
* Non-smoker
* Can read and understand the questionnaire.

Exclusion Criteria:

* Patients with depression or any psychological issues
* Those not willing to participate
Study Evaluating Drug Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606

To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when co-administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
A Study of Patients With Major Depressive Disorder and Residual Apathy

The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.

Apathy is reported by up to 30% of patients with major depressive disorder (MDD) and is hypothesized to be a treatment emergent adverse effect associated with selective serotonin reuptake inhibitor medication. While there is currently no consistent method for treating apathy among psychiatrists, it has been proposed that switching MDD patients to antidepressant medications containing both serotonin and norepinephrine, such as duloxetine, may reduce the incidence and severity of apathy in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
* Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
* Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score \>30 at screening and randomization.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of \<2 at screening and randomization.
* Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
* Have previously completed or withdrawn from this study or any other study investigating duloxetine.
* Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
* Presence of an Axis II disorder
* Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
* Positive urine drug screen for any substance of abuse or excluded medication.
* Are pregnant or breast-feeding.
* Serious medical illness, requires hospitalization during the study
* Have uncontrolled narrow-angle glaucoma.
* Have acute liver injury or severe cirrhosis
* Abnormal thyroid stimulating hormone (TSH) concentration
* Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.
A Study of Incoxil Food Supplement in Female Patients With Stress Dominant Urinary Incontinence.

The purpose of this study is compare the effectiveness of Incoxil food supplement and pelvic floor muscle training with pelvic floor muscle training alone in the treatment of women with stress dominant urinary incontinence.

Pelvic floor muscle training (PFMT) is the first line therapy recommended for the treatment of stress urinary incontinence. The study aims to investigate how poor pelvic floor muscle function can be strengthened by performing pelvic floor exercise and using a special dietary supplement at the same time, and if stress urinary incontinence can be improved more effectively than by performing pelvic floor exercise alone.

The study aims to compare the clinical improvement in the symptoms of stress urinary incontinence in women who do pelvic floor muscle training exercise (PFMT) or who do PFMT exercise and use a dietary supplement. Incoxil dietary supplement contains ingredients that are specifically designed to help strengthen muscles (creatine, l-leucine, zinc, calcium and magnesium).

The randomized controlled clinical trial is proposed involving 34 women diagnosed with stress dominant urinary incontinence and randomized into two groups: 1) treatment with Incoxil dietary supplement and PFMT; 2) treatment with placebo dietary supplement and PFMT. All women will perform PFMT daily and women in group 1 take Incoxil every day, while women in the control group will take daily placebo dietary supplement for 6 weeks.

At baseline assessment, patients shall undergo anamnesis, general gynecological exam, assessments of the pelvic floor based on the modified Oxford scale, the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system, pelvic muscle contraction will be measured using a pelvic Perineometer and Vaginal Tactile Imaging will be used for evaluation of vaginal and pelvic floor conditions. We also assess the general health of the vagina with Vaginal Health Index scores. Participants shall complete UDI-6, PGI-S/I and IIQ-7 questionnaires.

After 6 weeks treatment the same assessments will be done to compare treatment and control group results.

Eligibility Criteria:
Inclusion Criteria:

* stress UI or stress-dominant mixed UI (stress percent score more than urge percent score)

Exclusion Criteria:

* pregnancy or less than 12-month postpartum
* more than three vaginal deliveries or any prior operative delivery
* self-reported symptoms of pelvic organ prolapse or POP-Q stage \>2
* history of supervised PFMT within 12 months
* current medications for UI
* known zinc or copper deficiency or sensitivity
* connective tissue disease
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study

Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy.

Observations made in this study may be used to plan a more definitive follow-on investigation.


Eligibility Criteria:
Inclusion Criteria:

* a polysomnogram study or home sleep test within the previous six months that shows either an AHI \> 15 and AHI \<= 30
* able, in the opinion of the investigator, to understand and comply with all study procedures
* the vNEP collar is determined by the investigator to properly fit the subject and is well-tolerated after application to the neck.
e-Mobile Tablet for People With Chronic Conditions

Maintaining a healthy diet and engaging in routine physical activity may help decrease severity of symptoms, prevent secondary conditions, and slow functional decline in people with disabling neuromusculoskeletal conditions. However, people with these conditions face many health barriers to engaging in healthy behaviors. With the advent of portable technologies, such as smart phones, tablets and PDAs, there is a need to explore whether these technologies can help people with disabling conditions to stay motivated and overcome barriers to engaging in healthy behaviors.

The overarching goal of this mixed methods, comparative effectiveness randomized controlled pilot study is to evaluate whether goal setting, self-monitoring, and barrier management using a computer tablet can increase physical activity behavior, improve nutritional habits, and promote health-related quality of life in people with disabling neuromusculoskeletal conditions. Our hypothesis is that, in comparison to the standard care contact control group, participants in both the tablet group and the paper and pencil group will yield significant improvements in healthy behaviors,with the tablet group yielding significantly larger increases.

Eligibility Criteria:
Inclusion Criteria:

* Physician-confirmed diagnosis of a neuro-musculoskeletal condition or disease of the nerves, muscles, and/or bones that results in functional limitations
* Physician consent to engage in home exercise/physical activity program
* Regularly inactive (i.e., engaging in 90 minutes or less of purposeful physical activity each week)
* Scoring ≤17 mental composite and ≤16 physical composite on the Global Health Questionnaire.
* Have internet access (i.e., home, library or other WiFi location)

Exclusion Criteria:

* If the only disabling condition reported is not considered a neuro-musculoskeletal disease
* Have hand-motor function impairments that would limit use of the tablet
* Often engage in healthy eating habits
* Are frequent fallers (i.e., more than 3 falls per month)
* Have a diagnoses of chronic obstructive pulmonary disease, serious mental health disorder, chronic heart failure, myocardial infarction, and other unstable/severe cardiovascular conditions, and uncontrolled diabetes mellitus (e.g., admission to the hospital within the past 6 months for uncontrolled diabetes)
* Have severe cognitive deficits
* Reports consistently tracking and monitoring health behaviors
* Unable to effectively use the tablet technology during the pre-intervention usability demonstration