cyrilzakka/clinical-trials huggingface dataset:
An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)

The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.

Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.

The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.

Eligibility Criteria:
Inclusion Criteria:

* History of coronary heart disease
* English or Spanish Speaking
* Elevated Depressive symptoms (PHQ9 ≥10)
* Appointment at participating cardiology or primary care clinics

Exclusion Criteria:

* Under the care of a psychiatrist \[\*\*On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period\*\*\]
* Diagnosis/history of psychosis or schizophrenia
* Diagnosis/history of bipolar disorder
* Attempted suicide
* Non-English or Spanish speaking
* Dementia or severe cognitive impairment
* Non-elevated depressive symptoms
* Alcohol or substance abuse
* Pregnancy
A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia

The purpose of this study is to evaluate the effects of the amino acid supplement N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.

Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve performance of patients with schizophrenia on a battery of cognitive tasks utilized to test working memory and other cognitive domains, versus placebo. This pilot study will utilize a randomized, double blind, placebo controlled, crossover design.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be between 18-60
* Meet Diagnostic and Statistical Manual-IV (DSM) criteria for schizophrenia
* Be on a stable dose of antipsychotic medication for at least 1 month
* Be deemed clinically stable for 3 months by the regular clinical staff

Exclusion Criteria:

* Current substance or alcohol abuse
* Pregnancy
* Clozapine treatment
* Known sensitivity to sulphur containing compounds
* Previous diagnosis of mental retardation
* Nitroglycerin use
* Asthma diagnosis, verified and treated by a primary care doctor
* Use of any other medication that may interact with the study medication
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.


Eligibility Criteria:
Inclusion Criteria:

* receive at least 80% of their nutritional needs via gastrostomy
* receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula
* receive their bolus feeds within 30 minutes or less.

Exclusion Criteria:

* have undergone anti-reflux surger
* receive post-pyloric feeds
* receive regular daily prophylactic antibiotics.
CE Mark Study for the Harpoon Medical Device in Poland

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.

Eligibility Criteria:
Inclusion Criteria:

* All subjects referred for mitral valve surgery
* Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.
* Age \> 18 years
* Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
* Degenerative mitral valve disease
* Subject is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
* Women of child-bearing potential have a negative pregnancy test
* Able to sign informed consent

Exclusion Criteria:

* Age \< 18 years
* Infective endocarditis
* Anterior or bileaflet prolapse
* Functional mitral regurgitation
* History of Mediastinal Radiation
* Inflammatory (rheumatic) valve disease
* Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
* Symptomatic coronary artery disease
* Cardiogenic shock at the time of enrollment
* ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
* Evidence of cirrhosis or hepatic synthetic failure
* Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
* Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
* Previous cardiac surgery, or surgery on the left pleural space
* Left ventricular, atrial or appendage thrombus
* Severely calcified mitral leaflets
* Recent stroke (\< 6 months) with permanent impairment
* EuroScore (for mitral valve repair) \> 8%
* Subjects with contraindications to transesophageal echocardiography
* Severe left or right ventricular dysfunction
* NYHA Class IV
* Renal insufficiency CKD stage 3b or worse (GFR \< 45 ml/min/1.73 m2)
* Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
* Patient with non-cardiac co-morbidities and life expectancy \< 1 year
* Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures
Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction

The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. The main questions it aims to answer are:

does Coenzyme Q10 help with better tissue healing? does Coenzyme Q10 administration lower the prevalence of Dry socket after surgery? does Coenzyme Q10 prevent TMD (Temporomandibular disorders) while recovering from surgery? how does Coenzyme Q10 administration effect the answers to SF-36 health survey in patients? Researchers will compare Coenzyme Q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters.

Participants will:

* take coenzyme Q10 (100mg) daily for 30 days after surgery.
* will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.

Exclusion Criteria:

* The patient's departure from Sanandaj
* The patient's disagreement with the study protocol
* The Patient's demise
* The patient's hospitalization for unrelated illnesses
* The patient's discontent with the care they received
* The patient's failure to show up for follow-up appointments
* The patient's sensitivity to Coenzyme Q10
MI-based PrEP Intervention

Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy in preventing HIV infection among MSM. However, uptake in clinical settings has been slow for several reasons, including low awareness and education, low perceived HIV risk, concern for side-effects, and stigma associated with taking the medication. The purpose of the proposed study is to develop and evaluate a brief motivational interviewing (MI) intervention to promote PrEP uptake among MSM during the course of routine HIV screening at a public sexually transmitted disease (STD) clinic.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Assigned male at birth and currently identify as male
3. Score at least 10 on the HIV Incident Risk Index for MSM
4. HIV-negative based on results of antibody test
5. English- or Spanish-speaking
6. Have access to a working phone
7. Have not taken PrEP

Exclusion Criteria:

1. Have previously taken PrEP
2. Symptoms of acute HIV infection at baseline
3. HIV positive
4. A clinical contraindication to PrEP (e.g., renal dysfunction)
5. Non-English or non-Spanish speaking
Tunnel Access for Horizontal Alveolar Ridge Augmentation

Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .

Several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility.

The tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. The significant benefit of this approach is that it may be closed without the need for periosteal incisions. Several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. This clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using Biphasic Calcium Phosphate and Acellular Dermal Matrix.

This minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of Biphasic Calcium Phosphate) and its mucosal component (through the use of Acellular Dermal Matrix). Compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older

  * No general medical condition representing a contraindication to implant therapy
  * minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
  * No periodontal disease (periodontal probing depth \<4 mm) or treated periodontitis
  * Good oral hygiene (full mouth plaque index\<25%)
  * Adequate control of inflammation (full mouth bleeding on probing\<25%)

Exclusion Criteria:

* smoking of more than 15 cigarettes a day • untreated periodontal disease
* pregnancy or breastfeeding at date of inclusion • acute infections
* keratinized mucosal tissue less than 2 mm.
Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit

The overall aim of this study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

The frequency of stage T1 superficial colorectal cancer (CRC) is around 15% and its incidence increases. In France, T1 superficial CCR is mostly treated with endoscopic submucosal dissection (ESD), offering potentially curative, organ-preserving treatment. The presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. Strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. Organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes.

Our team showed that the type, density, and location of immune cells in CRC strongly correlated with patients' survival at all disease stages. Our team created an "Immunoscore" (IS) assay, based on CD3+ and cytotoxic CD8+ T-cell densities determined by digital pathology in the tumor and its invasive margin. The robustness and prognostic performance of IS was validated in CRC . Sub-analysis of T1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection.

The objective of the study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* patient with Stage T1 colorectal tumor
* treated by endoscopic resection between 2014 and 2019 in one of the participating sites
* sample of the resected tumor available for central analysis

Exclusion Criteria:

* Other Synchronous cancer
* Synchronous CRC
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study

The principal investigator hypothesize that premature newborns have disturbed cardiac performance and increased pulmonary pressures during neonatal life and at different pediatric ages.

The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes.

The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes and that novel echocardiography techniques will detect anomalies not uncovered by conventional imaging, and that early echocardiography may identify those with later pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at \<29 weeks' gestational age admitted to the NICU
* All infants born at \<29 weeks' gestational age followed at MCH clinic after an admission in the NICU for prematurity \<29 weeks

Exclusion Criteria:

* Congenital heart disease (except an atrial (ASD) or ventricular septal defect (VSD), or a patent ductus arteriosus (PDA))
* Congenital severe lung or airway malformation (choanal atresia, trachea-esophageal fistula or congenital pulmonary airway malformation)
* Genetic disorder (Trisomy 21).
Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.

Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.

The investigators want to assess the lung ultrasound performance compared with the gold standard.

Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
* Never received any biotherapy or targeted therapy
* Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)

Exclusion Criteria:

* Refusal to participate in the study
* Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
* Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
* Patient with signs of cardiac decompensation
* Patient with pulmonary auscultation suggestive of PID
* Pregnant or lactating woman
* Psychiatric pathology seriously hindering understanding
* Difficulty understanding oral French
* Person deprived of liberty or under legal protection
Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

Small bowel adenocarcinoma is a rare malignancy, and there is limited knowledge about its optimal clinical management and molecular background. The SBAMOL study is an observational biomarker study that aims to identify prognostic and predictive biomarkers. This effort is intended to lay the groundwork for personalized medicine tailored to this specific patient group.

Small bowel adenocarcinoma (SBA), an orphan cancer, has annual diagnoses of 12,070 in the USA and 100 in Denmark. Despite its rarity, patient management should prioritize evidence-based care, but large trials are not feasible, leading to data scarcity and suboptimal care. As a result, SBA is treated like colorectal cancer, yet its prognosis is worse, indicating this parallel approach is insufficient. The grasp on SBAs molecular landscape is limited compared to prevalent cancers. Scant mutational profiling studies, suggest SBA is a heterogeneous disease where subsets resemble other gastrointestinal cancers. This underscores the potential for personalized treatments, including targeted therapies and immunotherapies. Comprehensive molecular characterization, using DNA, RNA, and T-cell receptor characteristics, can provide much-needed strategic direction for patient care and future trials. Capitalizing on this, the investigators propose a comprehensive molecular characterization aiming to develop consensus molecular subtypes that can direct future trials and SBA therapeutic strategies.

The investigators hypothesize that a consensus molecular profiling approach can identify subgroups of SBA with distinct molecular, cellular, and histological characteristics, that will benefit from tailored treatment strategies using chemotherapy, targeted therapy, and immunotherapy.

To explore this hypothesis, the investigators will: (WP1) perform molecular and immunological characterization of tumor tissues from SBA patients (n=200) to establish consensus molecular subtypes of SBA and define their biological attributes; (WP2) ascertain therapeutic avenues tailored to each subtype and devise a molecular algorithm to prospectively categorize individual tumors in real-time, laying the groundwork for molecularly-driven management.

Eligibility Criteria:
Inclusion criteria:

Patients with histologically verified small bowel adenocarcinoma Patients older than 18 years

Exclusion criteria:

Insufficient material for molecular testing Patients registered in Vævsanvendelsesregistret\&

Vævsanvendelsesregistret; refers to a central Danish registry where patients can opt out of allowing their biological material to be used for purposes other than their own disease management.
Cat-PAD Exposure Chamber Study

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy.

This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years
* Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
* Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to cat allergen
* FEV1 of less than 70% of predicted
* Subjects who cannot tolerate baseline challenge in the EEC
* Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)