cyrilzakka/clinical-trials huggingface dataset:
Extended Cessation Treatment for Teen Smokers

This study is designed to test the efficacy of an extended smoking cessation program for teen smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.

Adolescent smokers (aged 14-18; \> 10 cigarettes/day) attending continuation high schools in the San Francisco-San Jose Bay Area will serve as the target population for this study. 280 smokers meeting eligibility criteria will be randomized. Our primary goal is to examine the effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking abstinence. All 280 smokers will receive 10 weeks of open label treatment consisting of nicotine patch therapy and group-based, intensive self-regulatory skills training (ST). Following open label treatment, half (n=140) will receive nine additional group-based ST sessions delivered over a 14 week period. Telephone counseling will also be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=140) will not receive any additional therapy beyond that provided in the open label treatment phase. Abstinence and relapse will be assessed at the end of open label (10 weeks) and extended treatment (24 weeks) and at 52 weeks from the time of study entry. Our primary hypothesis is that smokers randomized to extended treatment will have a higher prolonged abstinence rate (PA) at 52 week follow-up than participants receiving only open label treatment. PA at 52 weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking following an initial 2-week grace period during which any smoking is not counted as a failure and an expired-air carbon monoxide level of \<9PPM. Here, failure is defined as either seven consecutive days of smoking or smoking on at least one day on each of two consecutive weeks. Point prevalence abstinence will be examined as a secondary outcome and defined as no smoking, not even a puff, for seven consecutive days prior to assessment and an expired-air carbon monoxide level of \<9PPM. With 150 participants per cell, we will have, in general, 80% power at a 2-tailed alpha of .05 to detect a difference in abstinence rates of at least 15% over a large range of success probabilities.

Eligibility Criteria:
Inclusion Criteria:

Age 14-18 at the beginning of the study

Smoking at least 10 cigarettes per day

At least one quit attempt in previous 6mos

Exclusion Criteria:

Current DSM-IV disorder (depression, panic disorder, social anxiety disorder and agoraphobia)

Current self report of daily or heavy use (more than three times per week) of any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.)

Positive urine pregnancy test

Currently on bupropion (Wellbutrin, Wellbutrin SR, Zyban) or other antidepressants, MAOI's, antipsychotics, benzodiazepines

Currently on NRT

Currently receiving formal treatment for substance abuse problem, depression or anxiety
Higher Intensity Interval Training in Cardiac Rehabilitation

The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Male or female
* Angiographic documentation of CAD

Exclusion Criteria:

* Unstable angina pectoris
* MI / PCI \< 3 weeks
* CABG \< 4weeks
* Exercise induced ischemia \> 1mm ST depression
* LVEF \< 40%
* complex ventricular arrhythmias or atrial fibrillation
* orthopedic limitations to treadmill exercise
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation

The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
* Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
* A positive urine drug test.
Treatment of Mild and Moderate Cases of Gynaecomastia

This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay.

This study will be carried out on patients with gynecomastia presented to the Plastic Surgery Department, Sohag University, in the period between January 2021 to January 2022 as a retrospective and prospective study.

Patients will be divided into 2 groups:

group A treated with suction-assisted liposuction. group B treated with peri-areolar surgical excision. Each group contains 20 patients.


Eligibility Criteria:
Inclusion Criteria:

- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.

Exclusion Criteria:

* Patients with endocrine causes. Patients with genetic causes. Severe cases of gynecomastia. Patients who refused surgical intervention. Patients who are not fit for surgery. Patients with chronic illness.
Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy

The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations

Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). Patients with a VAS≤ 3 will be excluded.

PecFent and Placebo will be delivered by Archimedes Pharma When starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (Pecfent® ) 100µg in naive patients or 1 dose of Pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient VAS collected before and at the end of the radiotherapy session. Finally patient \& radiotherapists global satisfaction will be collected An assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a Patient global satisfaction

Study follow up:

Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* More than 18 years old
* Proven histological cancer with bone metastasis
* SignedInform consent form
* Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session

Exclusion Criteria:

* VAS\>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session
* Any SAO treatment on going
* Pregnant or lactating woman
* Hypersensitivity or safety issues to any opioïd treatment
* Poor nasal mucosa (defined on clinical doctor assessment)
* Severe obstructive lung conditions or respiratory depression
* Renal insufficiency with creatinine clearance inferior to 45 ml/min
* Hepatic insufficiency
* Patient misunderstanding of the content and objective of the trial
* Patient under supervision or guardianship
* SAO intake 4 hours before the radiotherapy session
* Patient participating to any other pain management trial
* Morphine pump usage
Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand

The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hand osteoarthritis
* Joint tenderness and/or redness
* At least one erosion by X-ray (as determined by the central reader)
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* History of inflammatory disease other than hand erosive osteoarthritis (EOA) including: secondary post-traumatic osteoarthritis (OA); rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
* History of gout, pseudogout, or hemochromatosis
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply
Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease.

OBJECTIVE: To determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.

MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that will include 150 patients with moderate-severe COPD (age \<75; BODE 4-10) with a 3 years follow-up. All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1) 2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment.

OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and reduction of health expenditures in GR1 compared to GR2.


Eligibility Criteria:
Inclusion Criteria:

* COPD Patients
* Less than 77 years
* BODE index of 3-10 (BODE 3 when FEV1\<50% v. Ref.).
* clinically stable (at least one month)
* Informed consent signed

Exclusion Criteria:

* Bone or muscle disease that limits the exercise training.
* Heart disease that disable physic exercise.
* Bronchiectasis or other Respiratory diseases different than COPD.
* Comorbidity that difficult o disable respiratory rehabilitation program carrying out.
* Life expectation less than 2 years.
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.

This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.

Eligibility Criteria:
Inclusion Criteria:

One of the following VT events (within the last 6 months) + Ejection Fraction \<40%:

A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic.

B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD.

Exclusion Criteria:

* Contraindication to VT ablation
* Renal failure (CrCl \< 15 mL/min)
* NYHA IV or CCS IV angina
* STEMI within 1 month
* CABG within 3 months
* PCI within 1 month
* Pregnant
* Life expectancy \< 1 year
Assessing the Quality of Life of Patients With Rosacea

The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* the inclusion criteria were: age ≥ 30 years,
* diagnosis of rosacea according to the criteria of the National Rosacea Society Expert Committee (NRSEC) from 2019,
* tolerance to the ingredients of the preparation used in the cosmetic intervention,
* lack of pregnancy and lactation,
* completion of a survey,
* signed informed consent

Exclusion Criteria:

* age \< 30 years,
* patients with other facial skin diseases (e.g. acne, psoriasis, eczema),
* intolerance to the ingredients of the preparation used in the cosmetic treatment,
* patients with neuropsychiatric diseases, pregnancy, lactation,
* patients who did not sign informed consent to participate in the study
* did not complete the survey questionnaire.
A Study of LY3502970 in Healthy Overweight and Obese Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants with stable body weight for at least one month prior to randomization.
* Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
* Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %
A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants

This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator.
* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive.
* Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion Criteria:

* Any significant acute or chronic medical illness as determined by the investigator.
* Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable).
* Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention \[uncomplicated appendectomy and hernia repair are acceptable\]).
* History of known risk of bleeding.
* Inability to tolerate oral medication.
* Individuals (only females) who are of childbearing potential.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Long-term Outcomes in Patients With COVID-19

Long-term outcomes from coronavirus disease 2019 (COVID-19) are currently unknown. This study will collect daily living status of survivors of COVID-19.

The ongoing pandemic of coronavirus disease 2019 (COVID-19), due to the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2), has caused a worldwide increase in hospitalization for pneumonia with multi- organ disease. Survival from sepsis is associated with increased risk for mortality for at least 2 years. Therefore, substantial sequelae including new physical disability, new cognitive impairment and increased vulnerability to further health deterioration are likely to be seen in survivors of COVID-19. The investigators conduct this study to investigate daily living status of survivors of COVID-19 using telephone interview questionnaire including Activity Daily Living(ADL), modified Medical Research Council(mMRC),modified Telephone Interview for Cognitive Status (TICS-m), Zung Self-rating Depression Scale(SDS), Carcinologic Handicap Index (CHI), and New York Heart Association (NYHA) functional class.

Eligibility Criteria:
Inclusion Criteria:

* Survivors who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China

Exclusion Criteria:

* Patients who were \< 18 years
The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens

This study will test the efficiency of the Freespira Breathing System in youth.

The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or lower acceptability for long-term medication use for adolescent PD.

In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In children adolescents, PD itself is less common than in adults, but when present, PD is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.

Eligibility Criteria:
Inclusion Criteria:

* SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder
* Participants must be 9-17 years of age
* If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment

Exclusion Criteria:

* Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease
* Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study
* Currently undergoing breathing biofeedback elsewhere
* Demonstrate evidence of severe suicidal ideation or psychosis
* There is an active condition of asthma
Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* HIV-1 infection
* HIV RNA \<50 copies/mL \>12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)
* On treatment with dolutegravir/abacavir/lamivudine \>6 months

Exclusion Criteria:

* Previous AIDS events
* Pregnancy or pregnancy plan
* Decompensated cirrhosis (B or C CPT status)
* Intake of alcohol, substances, other drugs that may affect neurocognitive performances
* Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
* Certified diagnosis of major depression, psychosis, history of suicidal attempts
* Treatment with antidepressants or antipsychotic drugs
* History of virological failure with INSTIs
* Lack of knowledge of italian language
* Impossibility to obtain informed written consent
* HBsAg positivity
* Estimated glomerular filtration rate by CK-EPI \<50 mL/min per 1.73 m2