cyrilzakka/clinical-trials huggingface dataset:
Theta-Burst Neuromodulation for PTSD

The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.

The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.

TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic PTSD according to DSM-5 criteria
* Veteran (male or female)
* age between 18-70 years
* clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
* capable of independently reading and understanding patient information materials and providing informed consent

Exclusion Criteria:

* Cardiac pacemaker
* implanted device (deep brain stimulation) or metal in the brain
* cervical spinal cord
* or upper thoracic spinal cord
* pregnancy/lactation, or planning to become pregnant during the study
* lifetime history of moderate or severe traumatic brain injury (TBI)
* current unstable medical conditions
* current (or past if appropriate) significant neurological disorder, or lifetime history of:

  * seizure disorder
  * primary or secondary CNS tumors
  * stroke
  * cerebral aneurysm
  * primary psychotic disorder
  * bipolar I disorder
  * active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
  * active suicidal intent or plan
Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)

A 6-week treatment study to compare the reduction in cholesterol of two drugs MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.


Eligibility Criteria:
- Men and women greater than or equal to 18 years of age with elevated cholesterol levels and coronary heart disease (CHD), or atherosclerotic vascular disease may be eligible to participate in this study.
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.


Eligibility Criteria:
Inclusion Criteria:

* Patients, as defined by local regulations and local faricimab product label, who are initiating treatment with faricimab at time of enrollment or have initiated treatment with faricimab within 3 months prior to patient enrollment, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye according to the investigator's discretion in routine clinical practice for anti-VEGF treatment naïve and pre-treated patients.
* Patients have received at least one faricimab treatment (the first dose) in the study eye.

Exclusion Criteria:

* Concomitant participation of the patient in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to enrollment
* Current participation in any interventional clinical study
* Active ocular inflammation and/or suspected/active ocular infection in either eye
* Patients in whom the study eye has been treated with faricimab for more than 3 months prior to enrollment
* Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)
* Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)
* Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)
Pre to Postoperative Smoking Cessation

The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.

This study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention (i.e., varenicline + monetary incentives + brief counseling) into a hospital setting by recruiting elective bariatric surgery patients and assessing theoretically relevant baseline characteristics (e.g., factors influencing smoking decisions, such as smoking motivation, delayed discounting, and distress tolerance) that may predict smoking cessation and post-surgical recovery outcomes. Participants will be required to attend a screening visit at the Behavioral Pharmacology Research Unit (BPRU) located on the Johns Hopkins Bayview Medical Campus, during which the participants will answer questionnaires, complete computerized tasks, and undergo sensory testing. Participants will then attend approximately 6 weekly study visits leading up to their bariatric surgery, and approximately 6 more weekly study visits after the surgery, as well as a 30-day follow-up visit, all located at the BPRU at Johns Hopkins Bayview. During the 6 pre-surgery visits and 6 post-surgery visits, participants will undergo an intensive smoking cessation treatment that includes administration of a medication called varenicline that has been FDA-approved for smoking cessation, as well as behavioral counseling sessions and monetary incentives for remaining smoke-free. After completing all study visits, participants will be asked to return for a 30-day follow-up visit, during which they will complete several study measures once more. Throughout the study, participants will be asked to periodically complete questionnaires, computerized tasks, and sensory testing. Investigators will also track outcomes associated with post-surgical recovery, including duration of hospital stay, hospital readmission, post-surgical complications, and prescription pain-killer use post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Smoker who has surgery scheduled 5-10 weeks in advance

Exclusion Criteria:

* being contraindicated for varenicline use
* evidence of psychiatric instability
* being unwilling/unable to adhere to the study schedule
* be unwilling to provide study access to medical records
* being otherwise judged by the study team to be inappropriate for study participation
The Long Term Effects of COVID on Pulmonary Function

An observational cohort study of patients discharged from the ICU following admission with COVID19 infection, looking at their medical wellbeing 6 months after discharge from the ICU.

The COVID-19 epidemic has placed an unprecedented strain on medical services worldwide. Throughout 2020 and early 2021, hospitals and their critical care services have been inundated with patients suffering from critical illness due to COVID-19, some of whom developed multi-organ failure and required a prolonged ICU stay. While the medical literature is now replete with publications and research on the acute phase of illness due to COVID-19, including critical illness, there is a paucity of studies detailing the long-term outcomes following COVID-19 critical illness.

While the negative long-term physical health, mental health and quality-of-life related effects of ARDS have been well documented, there has been very little long-term COVID-19 ARDS specific outcome studies published.

This is an observational cohort study that aims to assess the long-term health outcomes of adult patients admitted to Mater Dei Hospital Intensive Care Unit with COVID-19 infection. Patients will initially be assessed at 6 months after discharge from ITU. They will be interviewed by trained researchers using validated questionnaires. These questionnaires will assess their physical health, mental health and functional status. Participants will be examined and asked to do a 6minute walk test also using validated non-invasive physical assessment tools. They will be offered pulmonary function tests to be carried out at the Pulmonary function laboratory.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Intensive Care Unit with organ failure secondary to acute COVID-19 infection and successfully discharged from Mater Dei Hospital and surviving beyond 6 months after discharge, will be offered inclusion in the study.

A positive COVID PCR result before or during the patient's admission will be necessary for inclusion in the study. Participants will be over 18 years of age, with no restriction as regards race, ethnicity or gender.

Exclusion Criteria:

* There are no exclusion criteria
A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Either have not started an EGFR TKI or may have started osimertinib within the last 9 weeks
* Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA
* Evidence of a concurrent P53 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
* Evidence of a concurrent RB1 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
* Must have a site of disease amenable to repeat biopsy and be willing to undergo a biopsy during treatment
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* Karnofsky performance status (KPS) ≥ 70%
* Age \>18 years old
* Ability to swallow oral medication
* Adequate organ function

  * AST, ALT ≤ 3 x ULN
  * Total bilirubin ≤ 1.5x ULN
  * Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min
  * Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3
  * Hemoglobin≥8.0 g/dL
  * Platelets ≥100,000/mm\^3

Exclusion Criteria:

* Pregnant or lactating women
* Started an EGFR TKI other than osimertinib or started osimertinib more than 9 weeks ago
* Any radiotherapy within 1 week of starting treatment on protocol.
* Any major surgery within 1 weeks of starting treatment on protocol.
* Any evidence of active clinically significant interstitial lung disease
* Continue to have unresolved \> grade 1 toxicity from any previous treatment
* Have pure small cell histology
* Corrected QT interval using Fridericia's formula (QTcF)\>475msec or any clinically significant (as deemed by the investigator) abnormalities in rhythm or conduction or morphology of the resting EKG.
* Patients are to be excluded from cisplatin treatment arm if they meet any of the following criteria:
* Creatinine clearance \< 60 ml/min
* Hearing impairment requiring assistive device
* Neuropathy
* The treating provider does not feel as though the patient should receive cisplatin
Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing diagnostic GIT endoscopy
* ASA I-II

Exclusion Criteria:

* Emergency endoscopy
* Respiratory infection and hyperactive airways
* History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
* Morbid obesity, and neuropsychiatric disorders
Stories to Prevent (StoP) HPV Cancers

This randomized controlled trial (RCT) evaluates the association of a narrative communication intervention on human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds. The intervention is a brief video from local cancer survivors narrating their stories with an HPV-related cancer diagnosis and recommending the HPV vaccine for cancer prevention. RCT participants will be the parents (n=200) of children ages 9-12 who have not initiated HPV vaccination. Participants will be randomized (1:1) to our intervention or control (placebo video) one week before their child's next primary care visit. Our primary outcome is HPV vaccine initiation (first dose of the HPV vaccine series) among children ages 9-12 at the time of the wellness visit. The study also explores the effect of narratives on theory-based mediators of HPV vaccination, including parents' cognitive (e.g., risk perception) and emotional reactions (e.g., hope, anticipated regret).

Despite the availability of the human papillomavirus (HPV) vaccine that can prevent over 37,300 HPV-related cancers in the US every year, only 62.6% of girls and boys were up-to-date in 2022. Low-quality provider recommendations and time constraints during clinic visits limit parents' opportunities to discuss and make HPV vaccination decisions. Pre-visit education to parents could complement provider communication to promote HPV vaccination. There is a critical need to identify better communication strategies to increase HPV vaccine uptake, including the use of narrative messaging and existing digital technologies in clinics and at home (electronic health records, patient portal, mobile devices). The Stories to Prevent (StoP) HPV Cancers Study is a randomized controlled trial (RCT) to evaluate the association of a narrative communication intervention delivered through digital and mobile technology before clinic visits on HPV vaccine initiation rates. A sample of 200 parents of unvaccinated children ages 9-12 will be randomized to receive our intervention or control (placebo video). Participants will be recruited from general pediatric and family medicine clinics affiliated with Penn State Health. We will also examine the effect of narrative communication on theory-based psychological mediators of HPV vaccine initiation and narrative communication processes, specifically parents' cognitive and emotional reactions.

Eligibility Criteria:
Inclusion Criteria:

* Parent/guardian of a 9-12 year old receiving primary care at a Penn State Health clinic
* Their child has not previously received or initiated the HPV vaccine
* Is able to read and understand spoken English or Spanish
* Has a valid email address and access to a mobile phone, table, desktop or laptop computer to engage in the intervention

Exclusion Criteria:

* Parent of guardian is less than 18 years of age
* Unable to read and understand spoken English or Spanish
* Does not have access to a mobile phone, table, desktop or laptop computer
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients.

The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

The trial consists of three cohorts

1. Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)
2. Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)
3. Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 yrs
* HOCM diagnosed by experienced cardiologists (European Society of Cardiology (ESC)-certified imaging cardiologists and/or finalized fellowship imaging)
* LVOT obstruction \>30 mmHg pressure gradient in rest, or \>50 mmHg during exercise by TTE and/or invasive measurement, performed experienced (imaging) cardiologists
* Symptomatic (NYHA class \>2 or CCS class \>2)
* Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction

Exclusion Criteria:

* LV wall thickness \<15 mm
* Other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease)
* Moderate to severe mitral valve regurgitation
* Systolic anterior motion of the mitral valve
* Coronary artery disease requiring intervention
* Pregnancy
Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy

This intervention study evaluates the effectiveness of a digital game intervention supporting smoking refusal self-efficacy among early adolescents (10-13 y). The participants are randomly allocated to two groups: the experimental group that receives the digital game intervention, and the control group that receives no intervention.


Eligibility Criteria:
Inclusion Criteria:

* Goes to school at 4th, 5th, or 6th grade
* Sufficient skills in Finnish or Swedish

Exclusion Criteria:

-
A Observational Study of Assessment and Treatment Adequacy of Emergency Cancer Pain in Tertiary Cancer Hospital

EMERGENCY CANCER PAIN MANAGEMENT HAS BEEN INCONSISTENT AND INADEQUATE ACROSS THE GLOBE. THIS STUDY AIMS TO KNOW EMERGENCY ROOM CANCER PAIN PATTERNS AND TREATMENT ADEQUACY IN TERTIARY CARE CANCER HOSPITALS.


Eligibility Criteria:
Inclusion Criteria:

* ADULT CANCER PATIENTS REPORTING TO EMERGENCY ROOM WITH COMPLAINTS PRIMARILY OF PAIN

Exclusion Criteria:

* PATIENTS BELOW 18 YEARS OF AGE AND PATIENTS WITH INCOHERENT BEHAVIOUR.
Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II

Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.

A pilot study in which semi-structured interviews will be conducted (Qualitative research).In addition, patients will be asked to fill in a questionnaire about the usability of the prototype. A small group of patients (n=15) that have been treated for early stage NSCLC in the past will be asked to participate. The persons involved in this pilot are asked to assess a patient decision tool and will be interviewed only once. After the interview they will be asked to fill in a questionnaire. The burden of the pilot study is very low. No medical examinations or procedures will be carried out. Pilot study in lung cancer patients treated in the past with radiotherapy or surgery. The participants will all give informed consent. The investigators are using a qualitative design. Semi-structured interviews will be carried out. In addition the investigators will ask the participants to fill in a questionnaire with 35 questions.

No age limits are defined. The pilot study will be carried out in stage I-II NSCLC patients who were treated with radiotherapy or surgery, at least 6 months ago. Patients should currently be free of disease, no disease progression. The semi-structured interview consists of 17 open questions and text recorded, in order to be able to analyze the date afterwards. The interviews will take place when the patients come to the hospital for a regular follow-up appointment. After the interview, the patient is asked to fill in a questionnaire about the usability of the decision aid. In total, the expected duration is about 2 hours.

Eligibility Criteria:
Inclusion Criteria:

Early stage non-small cell lung patients, Treated with curative intent minimum 6 month ago, max 5 years. Doctors IT

Exclusion Criteria:

Others