cyrilzakka/clinical-trials huggingface dataset:
Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment.

While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. Fortunately, the FDA has recently approved a long acting subcutaneous injectable formulation of buprenorphine. While this drug has proven effective in retaining patients in care and decreasing drug cravings as compared to placebo, this drug has not been tested in a real world clinic setting and no studies exist comparing it to the current formulations of buprenorphine. The objective of this study is to perform a randomized pilot study directly comparing sublingual buprenorphine/naloxone to long acting buprenorphine subdermal injection in a standard Office-Based Opioid Agonist Treatment (OBOT) clinic. The study team will compare patient retention, percentage of negative urinary drug screens, and withdrawal scores between the two groups. The findings will provide insight for US providers seeking more effective and efficient ways to treat Opioid use disorder (OUD) in the outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who present to the WFBMC Medication-Assisted-Therapy (MAT) clinic seeking OBOT.

Exclusion Criteria:

* Those patients who have:
* history of cirrhosis, \>= CKD stage 3
* congenital long QT syndrome
* those on antiarrhythmic medications
* liver enzymes more than 2 times the upper normal value at baseline assessment
* elevated bilirubin
* chronic pulmonary condition
* current unstable and untreated psychiatry comorbid disorder
* pregnant
* use of benzodiazepines/other CNS depressant medications
App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Sleep can affect frequency and occurrence of interictal spikes and occurrence, timing, and threshold of seizure. Epilepsy can worsen sleep architecture and severity of sleep disorders. Thus, a vicious cycle is set. Certain epilepsy syndromes are so intertwined with sleep that they are considered sleep-related epilepsies. Poor sleep in epilepsy is multifactorial and is worsened by poorly controlled seizures. App-delivered intervention has shown promise as a method to overcome health issues; however, the long-term effectiveness has not been proven in epileptic patients with chronic insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age
* diagnosis of epilepsy according to the International League Against Epilepsy criteria
* Self-report "moderate or severe" insomnia as indicated by a score of 15 or higher on the Insomnia Severity Index
* Can speak, understand, and write in Persian
* No surgery planned in the next 6 months
* Have access to an Android smartphone or a desktop computer with Internet access
* absence of major cognitive impairment or active psychiatric disorders

Exclusion Criteria:

* presence of a rapidly progressing neurological or medical disorder
* a diagnosis of mental retardation
* use of drugs or alcohol
* Untreated sleep apnea
* Current pregnancy
First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 50 years (inclusive) at the first screening visit
* Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

Exclusion Criteria:

* Clinically relevant findings in the physical examination
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration
External Nitric Oxide Measurement Through SNO Degradation

In this study, we aim to explore the feasibility of a novel, noninvasive SNO assay to acquire physiological SNO quantification from various parts of the human body and test this new method of analysis. This study aims to help with the currently cumbersome and invasive procedures used to measure SNOs in the body. The proposed activities do not unnecessarily duplicate previous experiments.

S-nitrosylation is the covalent attachment of a nitric oxide group to cystine thiol within a protein to form an S-nitrosothiol (SNO); it has diverse regulatory roles in all mammalian cells and thus operates as a fundamental mechanism for cellular signaling and accounts for a large part of nitric oxide activity. Though SNOs are relevant to many biological disciplines like neuronal, muscular, respiratory, and cardiovascular biology, currently there is no way to measure SNOs that is both easy to use in a clinical setting and accurate in detecting low concentrations; detection is challenging due to the labile nature of the molecules. Low or high concentrations of these molecules could be vital indicators of incoming dangerous issues in the body. A system to easily and accurately measure SNOs could prove useful in preventative treatments. Ultra Violet (UV) light can break SNOs and can be used to measure nitric oxide release, but this method is not fully developed and further research is needed on the potential effect for UV to measure nitric oxide release.

Eligibility Criteria:
Inclusion Criteria

* Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment

Exclusion Criteria

* Subjects meeting the following criteria will be excluded:
* Smokers.
* Any chronic skin conditions.
* Pregnant.
* Subjects that are unable or unwilling to cooperate with specimen collection.
* Subjects with diagnosis of any medical condition that in the investigator's opinion would make them unsuitable for study participation.
* (for subjects ≥ 18) Subjects that lack the capacity to consent for themselves.
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Eligibility Criteria:
Inclusion Criteria:

Part A:

* Able to provide written informed consent
* Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
* Additional inclusion criteria apply

Part B:

* 18 - 55 years old inclusive at Screening
* Active but clinically stable, plaque psoriasis
* Psoriasis involving ≥ 10% of the body surface area
* A minimum PASI score of ≥ 10 obtained during the screening period
* Additional inclusion criteria apply

Exclusion Criteria:

Part A:

* History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c \> 7%, history of splenectomy)
* Additional exclusion criteria apply

Part B:

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
* Additional exclusion criteria apply
Comparison of Transfemoral Amputees in Different Prosthesis Use Periods

Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Prostheses offer the potential to help these individuals regain their mobility as well as optimise their physical function. Especially for unilateral transfemoral amputees, there are a number of physical challenges they face during prosthesis use. These challenges can manifest as posture, balance and weight transfer problems that prosthesis users face in their daily lives. Correcting trunk posture, increasing the ability to maintain static balance and optimising plantar load distribution are critical factors affecting the success of prosthesis use. These challenges faced by unilateral transfemoral amputees during prosthesis use are closely related to post-amputation biomechanical changes. These changes can often lead to problems with balance, gait and functionality during activities of daily living. There is no effective comparative study based on computerised analysis data on posture assessment, static balance and plantar pressure distribution of transfemoral amputees.The aim of this study was to investigate the effects of prosthesis use by comparing posture, balance, gait and plantar pressure parameters of unilateral transfemoral amputees at different prosthesis use periods


Eligibility Criteria:
Inclusion Criteria:

* To be using unilateral hydraulic knee joint and carbon foot prosthesis.
* Being amputee at the transfemoral level
* Being new or using prosthesis for at least 3 years.
* Having undergone amputation due to trauma.
* To have completed prosthetic period rehabilitation.
* To be between the ages of 18-45

Exclusion Criteria:

* Having a wound-ulcer problem
* Having amputation due to diabetes, peripheral arterial disease, tumour or venous insufficiency
* Being diagnosed with any systemic or neurological disease
* Affected perception and cognition
* Body mass index above 30.
* Having lower extremity contracture
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.


Eligibility Criteria:
Male or Female 20-79 years old
Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. The purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS (criteria 2003)
* Healthy controls

Exclusion Criteria:

* any condition mimicking PCOS
* any systematic disease
Project Powerfood: Promoting Food Security, Equity, and Health

Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are:

1. Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
2. Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a fruit and vegetable box. Participants will have the option to purchase 2 boxes per month for 6 months.
3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese children who are food insecure and/or receive SNAP and/or WIC benefits. Examine/evaluate:

   1. Feasibility of program in a busy primary care practice
   2. Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
   3. Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)


Eligibility Criteria:
Inclusion Criteria:

* Food insecure and/or receive SNAP and/or WIC
* Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%)
* Pediatric patients: obesity, ages 5-11
* Speak English or Spanish

Exclusion Criteria:

* Food secure and do not receive SNAP or WIC
* Adult Patients: do not have diabetes
* Pediatric Patients: not obese, under 5 years old or between 11 and 18
* Speak neither English or Spanish
* Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)
Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation

Rhinoscope is useful to exam intranasal structure. This information could be utilized to select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more patent nose could be associated with decrease of the development of epistaxis which is most common complication in nasotracheal intubation.

Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In addition, even when there are no structural abnormalities in the nasal cavity, the wider nasal cavity can be intuitively identified. This information is expected to assist in the selection of nostrils. It has not yet been studied whether anesthesiologists select nasal cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis.

The purpose of this study is to determine whether the selection of a nostril for nasotracheal intubation by rhinoscope affects the incidence and severity of epistaxis.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II undergoing surgery under nasotracheal intubation

Exclusion Criteria:

* expected difficult intubation based on history, physical examination, weight.
* bleeding tendency
* past history of nasal surgery
* symptom of difficulty of nasal respiration
Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors. Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment

PRIMARY OBJECTIVES:

I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term work ability among breast cancer survivors (BCS).

SECONDARY OBJECTIVES:

I. Explore individual and workplace factors associated with work ability in BCS.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.

ARM II: Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.

After completion of study treatment, patients are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer
* Employed at time of cancer diagnosis (defined as paid employment \> 20 hours/week)
* Within six months of completion of active treatment
* Working during treatment or intending to return to work following active treatment
* Computer and internet access

Exclusion Criteria:

* Patients who do not intend to continue/resume working following treatment
* Develop distant metastases or progressive disease
* Prior diagnosis of malignancy at any other site except for in situ carcinomas of the cervix or non-melanomatous skin cancers
Tradipitant for Functional Dyspepsia

To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent
* Body Mass Index (BMI) of 18-35 kg/m2
* Absence of other diseases which could interfere with interpretation of study results

Exclusion Criteria:

* Current H. pylori infection
* Pregnancy or nursing
* Recent history of Alcohol Use Disorder or Substance Use Disorder
Coronary Anomalies in Congenital Heart Disease

This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now.

Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies.

Coronary artery anomalies will be described and statistical analysis will be performed.


Eligibility Criteria:
Inclusion Criteria:

* cradiac catheterization with angiography with congenital heart disease.

Exclusion Criteria:

* no congenital heart disease.
Making Intergenerational Connections Through Arts

The purpose of the study is to evaluate the impact on older adults' wellbeing of participating in a 10-week conversation about arts and culture with an international university student whose native language is not English.

Older adults residing in subsidized housing will participate in a series of online conversations over 10 weeks about various arts and culture with an international university student enrolled at the University of Alabama at Birmingham (UAB); each weekly session will last for about 30 min to one hour.

Participants will complete survey questionnaires before and after the 10-week conversation program, and an exit interview at the end of the conversation program.

Eligibility Criteria:
Inclusion Criteria:

1. Live alone
2. older than 60 years old
3. Residence in a subsidized apartment for at least one year
4. Able to carry on a daily conversation with or without hearing aids
5. Intact cognition as indicated by a score of greater than 5 on the Short Portable Mental Status Questionnaire (SPMSQ)
6. have a working smart phone that can do video-conferencing
7. being able to provide informed consent

Exclusion Criteria:

1. having physical, or sensory (visual or hearing) deficits or language barriers (non-English communicators) that may impede study participation
2. non-English speaker
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus

This study is a 2-part study.

Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.

Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).


Eligibility Criteria:
Inclusion Criteria:

* Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
* Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)

Exclusion Criteria:

* Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
* Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)
Beatboxing and Residual Speech Errors

This project will study the effect of practicing speech sounds via beatboxing on speech accuracy, engagement in therapy, and functional outcomes for older children and adolescents with speech sound disorders (SSDs). Though SSDs exhibited by young children are often considered, SSDs are among the most frequent communication disorders in school-aged and adolescent children. SSDs can persist until adulthood. Individuals exhibit residual speech errors (RSE) when speech sounds are produced incorrectly after the age of eight, the age at which speech production is expected to be error-free. Common RSE include /r/, /s/, and /z/, all of which have high frequency in American English.

Beatboxing is a unique manipulation of the speech mechanism in which the individual creates repetitive, percussive and other instrumental sounds by actually being the instrument. Beatboxing is engaging and increasingly found in a variety of musical contexts and mainstream culture. The broad objective of this investigation is to explore the impact of beatboxing as an intervention tool on the speech produced and the functional outcomes attained by children with RSE compared to a traditional articulation therapy approach.The effect of a beatboxing intervention approach (BEAT-Speech) will be compared to traditional articulation therapy and employs a two-group pretest-posttest design. Specifically, the research aims to 1) assess the impact of beatboxing on speech sound production accuracy and amount of targets produced during therapy; 2) examine the relative level of client engagement of individuals exposed to beatboxing intervention; and 3) explore influences of beatboxing experiences on communication, activities, and participation in social and daily interactions.


Eligibility Criteria:
Inclusion Criteria:

• diagnosed with a speech sound disorder due to residual speech sound errors

Exclusion Criteria:

* out of age range
* history of hearing, neurogenic, behavioral diagnoses that can contribute to speech disorder
* English is not first or preferred language
* concurrent treatment for speech goals