cyrilzakka/clinical-trials huggingface dataset:
Internet-based CBT vs. TAU for Stress-related Disorders

Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.

Non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. Cognitive behavior therapy (CBT) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. The overall evidence-base for CBT for these disorders is however fairly week and access to treatment is low. In a previously published randomized controlled trial we found that internet-based CBT can yield large effects on core symptoms of stress for these disorders. Delivering CBT via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. In the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. It is now therefore important to take the next step and investigate the effects of internet-based CBT in comparison to an active control condition. The primary aim of this study was to compare two internet-based treatments, CBT vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

Eligibility Criteria:
Inclusion Criteria:

* primary adjustment disorder or exhaustion disorder
* regular access to a computer and to the internet
* ability to read and write in swedish

Exclusion Criteria:

* substance abuse in the past 6 months
* lifetime psychosis or bipolar disorder
* suicide risk
* initiated or changed psychopharmacological treatment for depression or anxiety in the past month
* concurrent psychological treatment
* cognitive behavior therapy for stress-related symptoms in the past year.
ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Documented atrial fibrillation;
* Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Conditions preventing the patient from adhering from the study protocol;
* Emergency procedures.

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:

* Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
* Severe allergic reaction against body surface electrodes

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:

• Status after esophageal or gastric surgery

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:

• Contraindication to MRI

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:

• Prior catheter or surgical AF ablation.

Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):

* Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
* Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
* Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
The Role of CVP and EF in Patients With Cardio-renal Syndromes

The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

OBJECTIVES

The aim of the study is to explore association between increased central venous pressure (CVP), Ejection Fraction (EF) and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2.

BACKGROUND

The pathophysiology of impaired renal function in cardiovascular disease is multifactorial. Recent investigations suggest that management of patients based on low-flow theory does not lead to improved outcomes. Relative importance of right heart dysfunction (manifested as increased CVP) has not been evaluated . Precise understanding of bidirectional pathways by which the heart and kidneys influence each other is necessary to define optimal treatment strategies specific to the subtypes, as therapies directed towards one organ system may have beneficial or unfavorable effects on the other.

METHODS

The study is of non-experimental (observational) type, based on retrospective chart review. The patients' personal identifiers are concealed and an anonymized datasets used (unique code given to each patient, which is kept secure under the control of hospital staff).

Eligibility Criteria:
Inclusion Criteria:

* HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)

Exclusion Criteria:

* Independent risk factors for renal impairment (e.g. diabetes, sepsis)
* Primary nephropathy or secondary nephropathy due to diseases other than HF
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects who are 18-65 years of age.
* Non-childbearing potential females or those using birth control.

Exclusion Criteria:

* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
* History of significant gastrointestinal disease
* Any significant medical illness
* Gastrointestinal disorder or surgery leading to impaired drug absorption
* Currently using gastrointestinal medications
Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients

The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects.

The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks' treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure of patients were in normotensive limits according to the JNC VII
* Diabetes mellitus treated with oral antidiabetics or diet

Exclusion Criteria:

* Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease
* Anti-hypertensive treatment
A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System

The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.


Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 18 years of age.
* The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
* The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
* The patient has been informed about the nature of the study and has provided informed consent.

Exclusion Criteria:

* Patient has no distal runoff.
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
* Patient is pregnant or nursing a child.
* Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
* Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.
Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment

The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The investigators hypothesize that children receiving active "brain training" will show greater improvements in EF and related skills immediately after treatment than children receiving passive "brain training." The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.

* Investigators will talk to you by telephone to determine if your child might be eligible for the study.
* Children complete two baseline testing sessions to evaluate executive function (EF) and related skills
* Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills.
* After completion of the baseline testing, we will inform you of eligibility for the "Brain Training" phase.
* During "Brain Training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions.
* Children return for 3 more time points, immediately after the completion of "Brain Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "Brain Training."

Eligibility Criteria:
Inclusion Criteria:

* Age 4 or 5 years
* Born Full term (37 weeks gestation or greater)
* Diagnosis of ADHD or high ADHD symptoms (T-score 60 or greater on standardized behavior questionnaire)
* Able to comprehend task instructions

Exclusion Criteria:

* Major neurosensory impairment (ie blind, deaf) that interferes with testing
* Genetic syndrome
* Inability to comprehend task instructions
Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children.

Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication.

On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist .

Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients.

The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France)

Exclusion Criteria:

* Parental opposition to the participation of their child to the study
Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome

* The study will be a prospective open labelled double blinded randomized controlled study.
* The study will be conducted on patients admitted to Department of Hepatology from 2012 to 2014 at Institute of Liver and Biliary Sciences, New Delhi
* Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.
* Patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation)
2. Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)
3. AaDO2 \> 15 mm Hg on standing room air arterial blood gas (ABG)
4. Ability and willingness to give informed consent

Exclusion Criteria:

* Age \< 18 or \> 64
* Intrinsic significant cardiopulmonary disease
* Inability to perform pulmonary function tests
* Moderate to severe Pulmonary hypertension
* Advanced hepatic encephalopathy
* Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography
* Antibiotic use within the last one month
* Listed for liver transplant in next 4 weeks
* Current use of exogenous nitrates
* Active bacterial infections
* Known malignancy
* Known intolerance to Pentoxifylline or rifaximin
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis

The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.


Eligibility Criteria:
Main Inclusion Criteria:

* Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale.
* Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit 1.
* Have a negative viral conjunctivitis test in both eyes.
* Agree to discontinue use of eye/eyelid cosmetics during study participation.
* Agree to discontinue use of contact lenses during study participation.
* Be willing and able to provide informed consent and comply with the study requirements.
* Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study.

Main Exclusion Criteria:

* Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1.
* Have experienced signs and symptoms of bacterial conjunctivitis for \>48 hours prior to Visit 1.
* Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible.
* Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
* Have a known intolerance, sensitivity or allergy to the study medications or any of their components.
* Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1.
* Have a family member or household member enrolled in this study.
* Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
* Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

There will be 2 sequential parts to the study:

* Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening.
* Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.

Eligibility Criteria:
Key Inclusion Criteria:

* For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening.
* According to the assessment of the Investigator, is in good general health and can comply with study procedures.
* For participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following last study injection and is not currently breast/chest feeding.

Key Exclusion Criteria:

* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator).
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* History of myocarditis, pericarditis, or myopericarditis.
* Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed.
* Participant has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.