cyrilzakka/clinical-trials huggingface dataset:
Cognitive-behavioral (CBT) in ESRD Patients With Depression

Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has been little data so far particularly in terms of randomized clinical trials. Here, we investigate the effect of cognitive-behavioral group therapy for enhancing mental health and quality of life in patients with ESRD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease : on hemodialysis more than 3 months
* Patients with BDI-II score \>= 15 points
* Adult with age \>= 20 years old
* Patients who were able to understand and willing to sign the written informed consent

Exclusion Criteria:

* Patients on hemodialysis due to acute kidney injury
* Patients who are on admission
* Patients who are undergoing chemotherapy or radiation therapy due to progressive malignant disease
* Patients who are planning kidney transplantation within few months
* Patients with cognitive dysfunction, mental retardation, and drug addict
* Patients who are unavailable for adequate communication with researchers
* Patients who changed anti-depressive agent or dose within 2 months before/after the trial
Comparison of the VividTrac® Videolaryngoscope to Direct Laryngoscopy in Adults Under Manual Inline Stabilization

This is a prospective randomized clinical study to be performed in adult patients ages 18 and older who are undergoing surgical procedures requiring endotracheal intubation. Adult patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and the time to intubation will be compared and recorded. Patients in both treatment arms will receive manual inline stabilization. The study hypothesis is that the time to endotracheal intubation will be decreased in the VividTrac® video laryngoscope group when compared to direct laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be 18 years old and older requiring endotracheal intubation

Exclusion Criteria:

* Patients with increased pulmonary risk;
* Prior documentation of difficult endotracheal intubation;
* elevated intracranial pressure;
* those who lack legal representative consent
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)

This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

PRIMARY OBJECTIVES:

I. Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.

II. Development of a data bank of WES/WT and germline sequencing data for future analyses.

OUTLINE: This is an observational study.

Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.

Eligibility Criteria:
Inclusion Criteria:

* \* Subject age 18 years and older

  * Subject is scheduled for a bronchoscopy as part of standard of care
  * Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
  * Ability to provide blood or saliva sample
  * Enrolled in study IRB#16-009655
  * Ability to provide archived tissue
  * Subject is able to understand and adhere to study requirements and able to provide informed consent

Exclusion Criteria:

* \* Individuals who have situations that would limit compliance with the study requirements

  * Institutionalized (i.e. federal medical prison)
  * Pregnant
  * Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment
  * Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment
The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.

Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* Having mild to moderate depressive symptoms, with or without emotional lability
* Experiencing psychological distress

Exclusion Criteria:

* Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis
* Cognitive impairment
* The presence of an unstable medical illness that might preclude completion of the study -
Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction

Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using an ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA) anywhere from 24-72 hours after arriving to the hospital. When an invasive coronary angiography can not explain the cause of a myocardial infarction, an MRI of the heart (a CMR) is often done as a follow-up investigation.

A growing body of evidence suggests that performing a CMR before the planned ICA can provide an accurate diagnosis and defer the need for an ICA in many of these patients with NSTEMI.

KaPSICA-CMR is an observational pilot study at the Karolinska University Hospital which aims to validate, in a Swedish healthcare setting, the potentials of a CMR-first approach in patients with suspected NSTEMI. We plan on including 150 patients, both with (n=50) and without (n=100) previous myocardial infarction. In addition to a standard clinical CMR protocol, the study will test novel CMR techniques such as magnetic resonance angiography and magnetic resonance fingerprinting sequences in this cohort. Patients will be recruited at both the Solna- and Huddinge sites of the hospital and include patients referred to ICA from the Visby- and Södertälje hospitals. The findings on the CMR will be blinded to treating physicians, with exceptions for unexpected adverse findings. In the event that a CMR would be indicated in line with clinical practice, the CMR findings are unblinded.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation)
* Planned ICA where CMR can be performed without delaying ICA
* Able to provide written informed consent

Exclusion Criteria:

* Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR \<30ml/min/1.73m2, contrast allergy, and non-MRI compatible implants)
* Arrythmias which hinder CMR examination
* Previous CABG
* Hemodynamic instability
* Myocardial infarction \<6 months prior to inclusion
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation if an informed consent is obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years at time of consent.
2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
3. The site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.
4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
6. Subjects are with normal left heart function (EF ≥ 50%).
7. No indications for left-sided or pulmonary valve intervention.
8. Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC) width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram (TTE).

Exclusion Criteria:

1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
2. Subjects with previous transcatheter or surgical tricuspid valve procedure.
3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change (FAC) \< 20%).
5. Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+).
6. Subjects with active endocarditis or other infectious diseases.
7. Subjects with untreated severe coronary artery disease.
8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
9. Subjects with coagulation disorders.
10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
11. Subjects with cognitive disorders that can not cooperate the study or follow-up.
12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.
A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected.

This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable.

The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Eligibility Criteria:
Inclusion Criteria:

* Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid Arthritis
* Correction of Functional Deformity
* Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision of previously failed total hip arthroplasty
* Uncemented applications

Exclusion Criteria:

Absolute contraindications

* Infection, sepsis and osteomyelitis

Relative contraindications

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may be spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease
Communication Book in Pragmatic Communication in Vascular Aphasics

This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

Data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. In the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. The communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. Early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae.

This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent after information. Information is also given to the person of trust when it exists.
* aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted
* during the first year of onset of aphasia
* adults over 18 years old
* French
* phasic disorder of severe severity expression (overall severity score between 0 and 2 at the diagnostic battery for the assessment of aphasia scale)
* residual ability to understand clinical assessments and informed consent; information about the objectives and the procedure of the research will also be given to the patient's designated confidant
* motor capacity for comfortable sitting and transfers with help
* affiliation to health insurance
* no deficits in visual perceptual tests (researched using the visual decision of objects and Montreal protocol for the evaluation of visual gnosis), which allows the use of the communication book,

Exclusion Criteria:

* refusal or impossibility of consent
* disturbance of vigilance
* insane state
* psychiatric history requiring hospitalization in a specialized environment
* perceptual disturbance, visual agnosia not allowing the use of the image support
* pregnancy or breastfeeding
* administration after the occurrence of stroke of a product for which an effect on the recovery of aphasia has been reported: piracetam, bromocriptine, donepezil, dextroamphetamine (if treatment with these products has been performed, inclusion is possible after a weaning period of 15 days)
* simultaneous inclusion in another therapeutic protocol of language disorders
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).

In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 15 years,
* Currently pregnant,
* Attending first ANC visit,
* 27 weeks gestation or less
* Not currently experiencing CT/NG-related symptoms (determined by validated screening tool),
* Not treated for CT/NG in the past 30 days,
* Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care),
* Willingness to return for a test of cure if CT/NG test is positive during antenatal care,
* Will reside in Gaborone through the time of delivery and 1st postnatal visit,
* Willingness to have neonates tested for CT/NG at their first postnatal visit,
* Mentally competent to understand the informed consent.

Exclusion Criteria:

* Not mentally competent to understand study procedures or give informed consent,
* Individuals \< 15 years,
* Men,
* Women who are not pregnant,
* Pregnant women not attending their first antenatal visit,
* Pregnant women at \>27 weeks gestation
* Pregnant women with current STI-related symptoms (will receive standard of care),
* Treated for an STI in the past 30 days.
A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
* Reversibility to albuterol at least 12% and 200 mL

Exclusion Criteria:

* Any significant co-morbid disease, particularly cardiovascular
* Use of any maintenance therapy except short acting bronchodilators
* Smoking history \> or = 10 years
Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria

The objective of this study is to investigate the effect of Antimicrobial Photodynamic Therapy mediated by Erythrosine and blue LED in the reduction of bacteria in dental biofilm. This clinical trial will be carried out with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the Dental Clinic of Universidade Metropolitana de Santos. A split-mouth model will be used (n = 30), with group I control - conventional treatment and group II - conventional treatment and antimicrobial photodynamic therapy (aPDT). The bicarbonate jet will be used to remove dental biofilm in both groups. The treatment will be carried out in 1 session. aPDT will be performed before cleaning/prophylaxis, only in group II. Participants will rinse with the photosensitizer erythrosine (diluted to 1mM) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. Then, the D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2. The microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the irradiation procedure (group II) or prophylaxis (groups I and II). Biofilm samples will be collected before and after exposure, respectively, and sent to the microbiological laboratory for colony counting. After this period, the CFU's will be counted and the data will be submitted to statistical analysis for comparison of pre and post-treatment results and between groups (conventional X aPDT).


Eligibility Criteria:
Inclusion Criteria:

* The participant must present between 25% and 50% of biofilm index;
* Have at least 20 teeth present, without clinical probing depths greater than 3 mm.

Exclusion Criteria:

* Smokers;
* Uncontrolled diabetics or hypertensives;
* Cancer or its treatment;
* Pregnant women;
* Use of antibiotics in the last 6 months;
* Coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia and immunosuppression);
* Patients undergoing orthodontic treatment.
A Clinical Study of Bemcentinib with Standard of Care Chemoimmunotherapy in Untreated Advanced/metastatic Non-small Cell Lung Cancer Patients with a Mutation in the STK11 Gene

The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.


Eligibility Criteria:
Main Inclusion Criteria:

* Histologically-confirmed or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (Phase 1b) targetable with first-line treatment.
* Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (phase 2a) targetable with first-line treatment.
* Have not received prior systemic treatment for their advanced/metastatic NSCLC
* Have measurable disease per RECIST 1.1 as assessed by the investigator

Main Exclusion Criteria:

* Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung
* Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. \<=Grade 1 at baseline) from AEs due to a previous radiation therapy
* Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment