cyrilzakka/clinical-trials huggingface dataset:
Mindful Breaths: Mindfulness for Young Adult Vaping

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based interventions (MBI) as a vaping cessation intervention in young adults aged 18-29 who vape nicotine at least 25 days per month and are interested in cutting down or quitting. The main questions it aims to answer are:

* Can mindfulness practice reduce nicotine cravings in young adults?
* Is mindfulness practice an acceptable and feasible intervention for vaping cessation in this population?

Researchers will compare participants in the mindfulness intervention group to a control group that watches a video with calming music and images to see if mindfulness practice has a greater effect on reducing nicotine cravings.

Participants will:

* Complete a baseline survey and craving cue reactivity assessment.
* Engage in a 10-minute guided mindfulness meditation (intervention group) or view calming music and images (control group).
* Rate their cravings and the acceptability, appropriateness, and feasibility of the intervention after the session.


Eligibility Criteria:
Inclusion Criteria:

* Young adults aged 18-29 years old
* Residing in the United States
* Able to read and speak English
* Vape nicotine at least 25 days/month,
* Interested in cutting down or quitting vaping in the next 30 days (rated at least a 5 on a 10-point scale).

Exclusion Criteria:

* Using any nicotine-containing products other than e-cigarettes
* A current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric diagnosis of severe mental illness
* A current DSM diagnosis of substance use disorders other than tobacco use disorder
* Involved in regular mindful practice
* Undergoing current smoking/vaping cessation treatment (counseling and/or medication)
* Taking any medications that may potentially affect nicotine craving, consumption, or mood within the past 30 days.
Hairstetics Hair Implant Device Safety and Efficacy

This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study.

The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 19 years old.
2. Subject has hair loss and has chosen to undergo synthetic hair implantation.
3. Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
4. Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
5. Subject has Good general health.
6. Woman of child bearing potential must have a negative pregnancy test.
7. Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.

Exclusion Criteria:

1. Previous synthetic hair implantation or hair transplantation in the past 6 months.
2. Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
3. Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
4. Currently using steroid product with Immunosuppressive treatment.
5. Impaired coagulation.
6. Serious illness that may affect subject compliance to protocol.
7. Subject is using illegal drugs.
8. Participating in other clinical study.
9. Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
10. For woman: Pregnancy or breast feeding.
11. Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed
The Effect of AR in Patient Pre-operative Education

The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in adults undergoing spinal surgery. The main aims of this study are:

Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.

Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.

This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices.

This study will be performed on patients scheduled to undergo elective spinal surgery. The study will be a non-blinded, randomized clinical trial with a treatment arm and a control arm. After patient screening to determine eligibility and after patients are informed about the study and potential risks, all patients giving written informed consent will be randomized in a non-blinded manner in a 1:1 ratio to traditional preoperative patient counseling (control arm) or AR enhanced preoperative patient counseling (treatment arm). In the traditional preoperative patient counseling group, surgeons will explain the patients pathology and the surgery with only words and with or without pictures (MRI, CT, etc) and/or a generic 3D model. In the AR enhanced preoperative patient counseling group, the surgeon will have virtual, interactive models of the patients own anatomy projected through AR to show patients while describing the problem and how the surgery will be performed.

For all patients included within the treatment arm, the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection. When using Surgical AR, patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System (PACS) on the Medivis workstation. During preoperative consultation, the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset. For AnatomyX, a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient, patient family, and surgeon can exist.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years-of-age
* Undergoing elective anterior cervical discectomy and fusion (ACDF)

Exclusion Criteria:

* Prior surgery
* Vestibular dysfunction
* Cannot tolerate AR immersion secondary to physical or psychiatric impairments
* Cognitive impairment
* Emergency procedures
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)

The goal of this study is to obtain data about the effectiveness, reach, adoption, and implementation potential of an innovative, combined urinary/bowel continence workshop through a randomized controlled trial in six Wisconsin communities. This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers. We hypothesize that workshop participants will experience improvements in urinary and bowel incontinence symptoms, will have increased levels of care-seeking and self-efficacy for these conditions, and will maintain the self-management strategies taught in the workshop 3 months following completion of the workshop. We further hypothesize that this workshop will reach its intended target population (independent senior women with incontinence) and will improve their mental health by destigmatizing the condition of incontinence.


Eligibility Criteria:
Inclusion Criteria:

* qualifying symptoms within last 3 months
* able to speak English
* lives independently

Exclusion Criteria:

* new treatment for target symptoms within last 3 months
Action Mechanisms of Shock Waves on Pain

The aim of this study is to evaluate whether the intensity of pain perceived during the application of extracorporeal shockwave therapy (ESWT) is determinant for producing changes in pressure pain threshold (PPT) in asymptomatic subjects. The investigators will perform a single controlled random trial to three groups. Two of them will receive ESWT whereas the third group will get a cold pressure test (CPT).


Eligibility Criteria:
Inclusion Criteria:

* Absence of pain or illness
* No changes in cognitive ability
* Good command of Spanish, both spoken and written

Exclusion Criteria:

* People with systemic diseases, tumors, infections, pacemakers, clotting disorders, skeletally immature, fibromyalgia, whiplash history, dizziness or in physiotherapeutic or pharmacological treatment
* Pregnant women
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
* Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
* Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
* Infant is not receiving steroids.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
* Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

* Participation in another study that has not been approved as a concomitant study by AN
18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions

This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.

PRIMARY OBJECTIVES:

I. To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.

OUTLINE:

Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
* No restrictions based on gender or racial/ethnic background

Exclusion Criteria:

* Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors

TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
* Age: 18\~75 years old.
* Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
* Patients voluntarily joined the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

* Patients has had or is currently having other malignant tumors within 3 years.
* Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
* The patient had unmitigated toxic reactions due to any prior treatment.
* Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
* Patients have long-term unhealed wounds or fractures.
* The patient had experienced an arterial/venous thrombosis event in the past 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
* The patient has a history of psychotropic drug abuse and cannot quit or has mental disorders.
* Patients are taking cytochrome P450 3A (CYP3A) inhibitors or inducers.
* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
* Patients with brain metastases with symptoms or control of symptoms for less than 2 weeks.
* The patients were currently breastfeeding or planned to breastfeed during the study period.
* Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons
Performance and Safety of Otinova® Ear Spray

The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.

After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 5 years old
* Clinical diagnosis of otitis externa based on otoscopic exam:

  a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the OE signs (swelling, erythema and otorrhea)
* Ability to correctly administer Otinova as spray (not requiring tamponade), as judged by the Investigator
* Subject agrees to refrain from water immersion of the ears during the investigation
* Subject agrees to refrain from using other ear treatment products during the investigation
* For pediatric patients, provision of informed consent by subject and legal -Subject, and if applicable legal representative(s), are willing to comply with the protocol and attend all investigation visits.

Exclusion Criteria:

* Duration of OE signs/symptoms longer than 6 weeks
* Suspected perforated eardrum or eardrum fitted with drainage tube
* Post-mastoid surgery
* Prior otologic surgery within 6 months of enrollment (must be successfully healed)
* Conditions which may make it difficult to evaluate the therapeutic response (e.g malignant OE, abscess, granulation, polyps, congenital disorders)
* History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiation therapy
* Known allergy or sensitivity to any component of the device
* Use of topical or systemic antibiotics, corticosteroids or other treatment that could affect the study result within 7 days prior to enrolment
* Pregnancy or lactation at time of enrolment
* Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
* Participation in another clinical investigation within 30 days of screening
Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient is greater than or equal to 18 years of age
* Patient is referred to EUS-FNB for pancreatic mass lesions

Exclusion Criteria:

* Patient is younger than 18 years of age
* Patient refused and/or unable to provide consent
* Patient is a pregnant woman
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures


Eligibility Criteria:
Inclusion Criteria

1. Male or female and greater than or equal to 12 years of age;
2. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2
4. Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment
5. During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week
6. Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed

Exclusion Criteria

1. Presence of nonmotor simple partial seizures only;
2. Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;
3. Presence or previous history of Lennox-Gastaut syndrome;
4. A history of status epilepticus within 1 year prior to screening
5. Seizure clusters where individual seizures cannot be counted
6. A history of psychogenic seizures within 5 years prior to screening
Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed thymic carcinoma
* surgically inoperable Masaoka stage III or IV
* ECOG 0-2
* at least one measurable disease

Exclusion Criteria:

* previous myocardiac infarct history within 1 year before the enrollment.
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to or capable of providing consent to participate in the clinical investigation.
* Subject is between the ages of 20-75 years, inclusive.
* Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
* Subject has sufficient bone stock for the hip replacement device.
* Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.

Exclusion Criteria:

* Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
* Subject with a known allergy to metal (e.g. jewelry).
* Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
* Subject has active or recent joint sepsis.
* Subject with marked atrophy or deformity in the upper femur.
* Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
* Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
* Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
* Subject with known, active metastatic or neoplastic disease.
* Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
* Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.