cyrilzakka/clinical-trials huggingface dataset:
HOBSCOTCH Phase II

The purpose of this study is to determine the feasibility and efficacy of the home-based cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers. It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.

HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.

HOBSCOTCH Phase II is a replication study of the original HOBSCOTCH study, designed to translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study, with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Confirmed diagnosis of epilepsy, with controlled or uncontrolled seizures
* Subjective memory complaints
* No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
* Literate
* Telephone access

Exclusion Criteria:

* Subjects age 66-70 with a mention of a dementing illness in their medical record
* Severe mental disability or estimated IQ less than 70
* Significant visual impairment precluding reading or writing
* No reliable telephone access
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease

The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.

This study will also explore:

* How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
* The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study).

Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law.
* Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
* Must be modified Hoehn \& Yahr Stage 1 to 2.5 (inclusive).
* Must have a baseline UPDRS (Part III) motor score of at least 10.
* Subjects may be receiving an anticholinergic agent and/or MAO-B inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other PD medication.

Exclusion Criteria:

* A Mini Mental State Examination (MMSE) score \<26.
* History or clinical features consistent with an atypical parkinsonian syndrome.
* Any significant non-PD central nervous system disorder.
* Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders.
* History of cognitive or neuropsychiatric conditions.
* History of surgical intervention for PD.
* History of L-DOPA-induced motor or non-motor complication.
* History of malignancy.
* History of severe allergic or anaphylactic reactions to any drug.
* Clinically significant renal dysfunction.
* HbA1c \>7.0%.
* Clinically significant baseline ECG.
* Orthostatic hypotension.
* Treatment with L-DOPA/carbidopa or L-DOPA/benserazide for more than 6 cumulative months at anytime since subject's initial PD diagnosis.
Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Subject was enrolled in the QCC374X2201 study and completed per protocol

Exclusion Criteria:

* Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e. selexipag) since the last study drug intake in the QCC374X2201 study.
* Females who are pregnant, or who plan to become pregnant during the study, or who are breastfeeding
* Any known factor or disease that may interfere with treatment compliance or study conduct (i.e. drug or alcohol dependence)
* Subjects who withdrew consent from the study QCC374X2201
Impact of Mobilization on Cardiac Surgery

The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.

The hypotheses this study is that patients if conduct the program of early mobilization during hospitalization achieve better performance in the walk test (distance) at hospital discharge and 60 days after the surgical procedure compared to patients who only carry out the program of respiratory exercises. Intervention and control groups will receive breathing exercises up to 24 hours postoperatively, and the intervention group will also receive early mobilization exercises.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60\<PAM\<100 mmHg, heart frequency (HR) 60\<FC\<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) ≤ 20 bpm without signs of infection were included in this study.

Exclusion Criteria:

* : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment.
Temporomandibular Disorders and Balance Performance

This study aims to investigate the relationship of the temporomandibular joint with head posture, pressure pain threshold, and body balance.

This cross-sectional study was conducted on university students aged 18-30 between April 2024 and December 2024. In the evaluation of the students, the Fonseca Anamnestic Questionnaire was used for temporomandibular joint dysfunction, the Research Diagnostic Criteria for Temporomandibular Disorders Examination Form was used for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of the temporomandibular joint and surrounding muscles. An algometer device was used for pressure pain threshold measurement, a goniometer for head-neck posture, EMG for measuring the activation of the masseter muscle, and the Korebalance Premier-19 device for static and dynamic body balance measurement.

Eligibility Criteria:
Inclusion Criteria:

* Must be a student at Bandırma Onyedi Eylül University
* Must be willing to participate in the study
* Aged between 18-30

Exclusion Criteria:

* Individuals who have undergone masseter botox treatment
* Individuals diagnosed with temporomandibular joint disorders and/or bruxism
* Individuals with musculoskeletal problems showing evidence of specific pathological conditions, such as fractures or rheumatoid diseases related to the lower extremities, spine, and/or temporomandibular joint
* Individuals who have undergone any surgery related to the lower extremities, spine, and/or temporomandibular joint
* Individuals who have received physical therapy related to the lower extremities, spine, and/or temporomandibular joint within the last six months
* Individuals diagnosed with psychiatric disorders
Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States

Retrospective, cohort study chart review in patients with hypercoagulable states.

* Retrospective, cohort study chart review in patients at Methodist Health System
* Data will be pulled on all patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 year-old
* Patients with diagnosis of hypercoagulable state identified by ICD-9/ICD-10 codes
* Patients who were prescribed DOACs or VKA for primary or secondary prevention of thrombosis

Exclusion Criteria:

* Patients with FDA-approved indications of oral anticoagulants including atrial fibrillation or treatment/prevention of thrombotic events unrelated to specified hypercoagulable states
* Patients with incomplete electronic medical records
The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases

This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

Eligibility Criteria:
Patients with widespread involvement (e.g. psoriasis patients with 10 percent or more of body surface area involved) or with severe, recalcitrant localized involvement with a cutaneous disorder (e.g. keratoderma palmaris et plantaris).

Patients (and parents of patients who are less than 18 years old) must be advised of presently available alternative forms of therapy.

Patient must be available for and agreeable to regular follow up examinations in the clinic for clinical evaluation, blood tests, diagnostic x-rays and possibly skin biopsies.

The patient (and parent, guardian, or surrogate where appropriate) must give written informed consent after protocol, including its limitations and risks, are thoroughly discussed with the patients (and parents).

Patients who have multiple skin cancers because of xeroderma pigmentosum (XP).

No patients with persistently abnormal (SGOT or SGPT greater than 3 times the upper limit of normal) liver function tests.

No patients with persistent pre-treatment hypertriglyceridemia (greater than 300 mg/dl).

No patients with persistently abnormal (creatinine greater than 3 times the upper limit of normal) renal function tests.

No patients with presence of a significant neurological, musculoskeletal or other internal medical disorder which may be aggravated by the addition of retinoid therapy.

Patient must not be pregnant or anticipate such an event. Because of the long-term storage of etretinate, a known teratogen, fertile women who may be treated in this protocol, must have skin disease that is severe and recalcitrant to all other standard modalities. These women must also use an effective form of contraception (oral contraceptives or an intrauterine device) while on treatment and at least for 3 years post treatment.

No patients with chronic intake of excessive dietary vitamin A (more than 25,000 iu/day).
S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at protein expression in tumor tissue samples from patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.

OBJECTIVES:

* Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected tumor tissue samples from patients with stage II or III rectal cancer enrolled in clinical trial SWOG-9304.
* Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression.
* Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence.
* Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304.

OUTLINE: This is a multicenter study.

Paraffin-embedded resected tumor tissue samples are analyzed for protein expression levels (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by tissue microarray and immunostaining.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the rectum

  * Stage II or III disease
  * No metastases
* Enrolled on clinical trial SWOG-9304

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Low Fluoroscopy Afib Ablation Registry

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
* First or subsequent ablation procedures may be included
* Age 18-75

Exclusion Criteria:

* Known venous malformations or implanted instrumentation (IVC filter)
* Known PV stenosis
* Unable to provide consent
* H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
* Documented left atrial thrombus
* Prior ASD repair Pregnancy
* NYHA \>=3
* EF less than 35%
* CHF within 90 daysRecent MI or coronary revascularization within 90 days
* NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
* Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations
Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients

This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19.

The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death.

Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.

This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization.

The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints.

The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SARS-CoV-2
* Recently admitted to the hospital (≤ 72 hours)
* Not yet proceeded to ICU care

Exclusion Criteria:

* Patients transferred from other hospitals
* Participants in delirium state
* Participants with a recent history of endotracheal intubation
Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy

The purpose of this study is to determine whether choosing antibiotics based on a biofilm antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial susceptibility assay to treat CF patients with chronic P. aeruginosa infection with an acute pulmonary exacerbation is a safe intervention that will result in improved microbiological and clinical outcomes and decrease markers of pulmonary inflammation.

Cystic fibrosis (CF) is the most common fatal genetic condition in the Caucasian population and affects over 3,000 Canadians. Respiratory failure caused by chronic pulmonary infection is the primary cause of death in CF patients. The improved life expectancy of CF patients in the past several decades is due in part to the more aggressive use of antibiotics in the treatment of respiratory infections. However, there is currently no antimicrobial susceptibility assay that can predict which antibiotics will result in improved patient outcomes. Since Pseudomonas aeruginosa is known to grow as a resistant biofilm in the CF lung, antimicrobial susceptibility testing based on biofilm growth of P. aeruginosa may lead to different antibiotic choices that significantly decrease the pulmonary bacterial density of P. aeruginosa. A biofilm antimicrobial susceptibility assay thus has the ability to change the way antibiotics are chosen to treat CF patients and result in improved lung function and longer lives for all CF patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF based on the following: sweat chloride \> 60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF
* Chronically infected with P. aeruginosa (\>50% of respiratory specimens positive for P. aeruginosa in the 24 months prior to screening)
* Able to produce sputum (expectorated or induced)
* Able to reproducibility perform pulmonary function testing
* Written informed consent provided

Exclusion Criteria:

* Sputum culture negative for P. aeruginosa or with a density of less that 10\^5 CFU/g at screening
* Sputum culture positive for Burkholderia cepacia at screening
* History of B. cepacia positive respiratory culture within 24 months prior to screening
* Use of antibiotics other than those prescribed by the principal investigator
* History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option
* History of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option
* Post lung transplantation or listed for lung transplantation
* Pregnancy
* A septic or clinically unstable patient
* Presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data
Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men

The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was to provide a quantitative characterization of the mass balance, rates and routes of elimination, and metabolic pathways after a single intravenous administration of \[14C\]berzosertib. The purpose of Period 2 was to assess safety and efficacy of berzosertib in combination with topotecan.


Eligibility Criteria:
Inclusion Criteria: .

* Histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) =\< 1
* Evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Screening
* Participant has adequate renal, hematological and hepatic function
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with uncontrolled intercurrent illness including, but not limited to, severe active infection including, acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019 (Covid 19), immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension and symptomatic congestive heart failure
* Concurrent participation in another interventional clinical study is not permitted.
* Known hypersensitivity to the study interventions, a similar structural compound, or to one or more excipients used
* Prior or concurrent treatment with a nonpermitted drug/intervention from the first dose of study intervention administration, as defined per protocol.
* Other protocol defined exclusion criteria could apply