cyrilzakka/clinical-trials huggingface dataset:
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.

The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.

We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified \<8ppm).

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 - 70 years old
* Must indicate willingness to make a quit attempt in the next 30 days
* Must report being a daily cigarette smoker (including those labeled "little cigars") for past month
* Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV)
* Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks
* Must have a smartphone, tablet, or computer with ability to download apps
* Must currently receive mental health treatment
* Must sign release of information for current mental health treatment providers

Exclusion Criteria:

* Must not currently (in past 10 days) be taking varenicline (Chantix),
* Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
* Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
* Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
* Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
* Must not have pending legal matters with potential to result in jail time
* Must not be planning on moving outside local area in next 3-months
* Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
* Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE).

The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto Part 3. Patients meeting the eligibility criteria for enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering Part 3 of the study, if eligible. In Part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE.
* Active disease at the time of screening.
* Agreement to use an effective form of contraception for the duration of the study.

Exclusion Criteria:

* Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).
* Pregnancy or breastfeeding.
* History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.
* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.
* Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.
* History of cancer within 5 years of screening.
* Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.
* History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening
Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm

Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. The precision of an algorithm to predict bilirubin values 24-48h into the future is evaluated in this study.

Neonatal jaundice is common and mostly transient without need for intervention. To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. As the peak bilirubin concentrations are reached at days 4-6 after birth, and most infants are discharged home around 48 hours after birth, parents are often asked to return to hospital one or two days after discharge with their newborn baby to have the bilirubin value checked in order to prevent that hyperbilirubinemia requiring treatment is not missed. A precise prediction of the course of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to avoid unnecessary follow ups (both for the families and the health care system).

This study aims to evaluate the precision of the NeoprediX B1 algorithm. This algorithm predicts bilirubin values 24-48h into the future based on preceding values and some clinical variables. Five different scenarios will be explored, differing in the type, number and timepoints of measurements used for the prediction as well as the timepoint that is to be predicted.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infant
* gestational age at birth ≥ 34+0/7 weeks

Exclusion Criteria:

* Birth weight \< 1500g
* Gestational age at birth \> 42+6/7 weeks
* Genetically defined syndrome
* Severe congenital malformation adversely affecting life expectancy or admission for a priori planned palliative care
* Parents not fluent in German
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Liposomal Doxorubicin
* Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Prior adjuvant/neoadjuvant treatment allowed
* Measurable disease
* Able to perform activities of daily living with minimal assistance
* Age 18 years or older
* Adequate bone marrow, liver and kidney function
* Normal heart function
* Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Pre-existing moderate peripheral neuropathy
* History of significant heart disease
* Meningeal metastases.
* Prior chemotherapy for metastatic breast cancer
* No measurable disease (including bone only, pleural effusions, etc.)
* Receiving Herceptin therapy.
* Women who are pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Clinical and Neuropsychological Investigations in Batten Disease

This study aims to assess the natural history of Batten disease (Neuronal Ceroid Lipofuscinosis) by obtaining information about the motor, behavioral, and functional capabilities of individuals with Batten disease. This study will also refine and validate the Unified Batten Disease Rating Scale (UBDRS) as a clinical rating instrument for Batten disease.

Batten Disease is an inherited disorder that causes progressive cognitive and behavioral decline in children. There have been no systematic clinical studies of Batten Disease using standardized rating instruments with known inter-rater reliability and validity.

The Batten Study Group developed the Unified Batten Disease Rating Scale (UBDRS), a clinical rating instrument used to assess the motor, behavioral, and functional capabilities of individuals with Batten disease. Using the UBDRS, study investigators will evaluate participants approximately every year to track disease progression. The UBDRS is the primary natural history tool, but the study also includes neuropsychological assessment, adaptive function, quality of life measures, and other measures to assess the impact of Batten Disease. Participants will be examined at the University of Rochester Batten Center, Batten Disease Support and Research Association annual meeting, or remotely via televideo. Information related to racial and ethnic background, medical history, symptoms, medications, and diagnostic testing will be collected.

Eligibility Criteria:
Inclusion Criteria:

* child or adult with any form of Batten disease
* parent or legal guardian of a child or adult with any form of Batten disease

Exclusion Criteria:

- parent or guardian unable or unwilling to provide permission for the affected individual
Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy

The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* Born before 32 WA or having a birth weight under 1500g

Exclusion Criteria:

* Brain malformations
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 21 to 75
* Has osteoarthritis of the hip or knee
* Requires therapeutic doses of medications for osteoarthritis
* If female, must be of non-childbearing potential or practicing birth control
* Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

* Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
* Has certain medical conditions which may interfere with pain assessments
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Has had certain infections, injuries or illnesses within the last month
* Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
* Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
* Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
* Cannot discontinue pain medications, even for a short time, prior to the study start
PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel

Eligibility Criteria:
Inclusion Criteria:

* Healthy women

Exclusion Criteria:

* HIV infected women
Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children

The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.

Functional constipation (FK) is a common functional gastrointestinal disorder that affects children's quality of life. The reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. Laxatives and probiotics are commonly used to treat functional constipation. Therefore, treating constipation is very costly and there is not enough reliable data on this subject. When the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. When the studies were examined, studies using different methods were found. The main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. The effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.Based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to Rome IV criteria on constipation.

This study is a prospective, randomized and controlled trial. The study population consisted of infants and children aged 6 to 24 months. Sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: intervention gorup (n=30) and control group (n=30). Data were collected using the Interview and Observation Form, Primary Results Follow-up Form, and Bristol stool form scale.

Eligibility Criteria:
Inclusion Criteria:

* The infant is between 6-24 months,
* The infant was born at term,
* Birth weight between 2500-4500 g,
* Must have been diagnosed with functional constipation by the physician according to ROMA IV criteria,
* Mothers' ability to read, write and speak Turkish,
* Parent's willingness to participate in the research.

Exclusion Criteria:

* The infant has a congenital anomaly,
* The infant has any chronic disease,
* Having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,Children with any organic or metabolic diseases
* The parent has a verbal and written communication barrier.
Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic Therapy on Initial Peri-implantitis

Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.

Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, ages over 18.
2. Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.
3. Availability for the 12 month duration of the study.
4. Good general health (ASA classification I-II).
5. Signed Informed Consent Form.

Exclusion Criteria:

1. Medically compromised subjects (ASA classification III-V)
2. Pregnant or lactating females.
3. Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
4. Subjects treated for \>2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
5. Unwilling to participate in the study.
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis.

Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.

Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females age 30 and up
* Subjects with Fitzpatrick 4 to 9 degrees of elastosis
* Subject able to comprehend and give informed consent for participation in this study
* Subject must commit to all treatments and follow-up visits
* Subject must sign the Informed Consent Form

Exclusion Criteria:

* Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
* Subjects with any implantable metal device in the treatment area
* Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months or photosensitizing medications
* Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 9 months (in the treated area) Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treated area at the period of the study
* Subjects who have any form of malignant skin cancer on the treatment area
* Subjects with history of keloid formations or hypertrophic scarring
* Pregnant or lactating Subjects
* Subjects with Epilepsy or severe migraines
* Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
* Subjects with any Infection / abscess / dermatitis/ pains in treatment target area.
* Subjects who suffer from autoimmune disorders or diabetes
* Subjects with clotting disorders
* Subjects are suffering from psychiatric disorders and treated with psychiatric medications.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol
* Concurrent participation in any other clinical study
* Physician objection
Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups children were evaluated three times in the same day in order to verify cardiorespiratory parameters, clinical score of respiratory dysfunction and adverse effects.

Children up to 12 months old, admitted for acute viral acute viral bronchiolitis were selected. All children participating in the study should be in the first 48 hours of hospitalization. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance (RRC) technique with physiological solution (0.9%) instillation. In both groups children were evaluated three times in the same day (data collection 1 (C1) - performed early in the morning; data collecting 2 (C2) - performed in the early afternoon; and data collecting 3 (C3) - performed in the evening). In each data collection, cardiorespiratory parameters and clinical score of respiratory dysfunction were evaluated before procedures (T0), 10 minutes after (T1) and 30 minutes after (T2). Adverse effects were evaluated during the whole day of the study.

Eligibility Criteria:
Inclusion Criteria:

* acute viral bronchiolitis diagnosis
* indication for hospital admission

Exclusion Criteria:

* history of lung disease related to prematurity (bronchopulmonary dysplasia)
* heart diseases
* chronic lung diseases (cystic fibrosis)
* pneumonia
* unstable hemodynamic process (ARDS or sepsis)
* subcutaneous edema
* admission to the intensive care unit
* need for mechanical ventilation or tracheostomy
* neurological diseases