cyrilzakka/clinical-trials huggingface dataset:
A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.


Eligibility Criteria:
Inclusion Criteria:

* Adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria
* Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of 30 mm/hour or CRP of 1.5 mg/dL
* MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit, The dose of MTX and route of administration must have been stable for at least 8 weeks prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

Exclusion Criteria:

* Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
* Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
* NYHA (New York Heart Association) Class III or IV congestive heart failure
* current or history of, tuberculosis
* history of chronic infection, recent serious or life-threatening infection (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
* High risk of infection
* Have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to Baseline
* Have received previous B-cell therapy (eg. Rituximab)
* Have received any other biological therapy for RA within 24 weeks prior to Baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
* Have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
* Failed to respond to previous treatment with an anti-TNF drug
* Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
HIV-HCV Coinfection: Impact of Immune Dysfunction

Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged survival in infected individuals. As a result, other diseases are now becoming clinically significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.

Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.

Eligibility Criteria:
Inclusion Criteria:

* HIV antibody positive
* Positive HCV-RNA
* Age \> 18 years

Exclusion Criteria:

* Coagulopathy (prothrombin time prolonged \> 2 seconds from control)
* Presence of ascites
* Thrombocytopenia (platelet \< 70,000)
* Active or recent (within 3 months) opportunistic infection related to HIV
* Advanced HIV disease with life expectancy less than 1 year
* Renal failure
* Hepatitis B surface antigen positive
* Inability to give informed consent
Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine in different dose levels as adjuvant to local anesthetic was not previously reported for femoral nerve block.


Eligibility Criteria:
Inclusion Criteria:

* all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery

Exclusion Criteria:

* Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
Predictive Models of Readmission in Heart Failure

This is a prospective nested case-control study.

Our goals are to create predictive models to readmissions for heart failure and also to define profiles for patients who are readmitted during the first month after the index episode.

Patients who will be admitted in five hospitals in spain by the reason of a heart failure will be recruited during 18 months. Those who will be readmitted in a hospital up to a month after the index episode will be considered cases. Controls will be selected from the initial cohort of hospitalized patients.

Objective: To create models for predicting the risk of readmission short term (30-90 days) and medium term (one year).To identify differences between patients readmitted and not readmitted, and profiles of frequently preventable readmissions in our setting.

Methodology: Observational prospective cohort of patients who are discharged with a diagnosis of heart failure in 5 participating centers. further, a nested case-control will be developed in the previous cohort, being cases those readmitted and controls will be chosen according to age, sex, etiology of heart failure, comorbidities and functional status. Sociodemographic, clinical and health related quality of life, empowerment and baseline self-efficacy as predictors of readmission were collected.

Regarding the cases and controls, the quality of life in post-discharge transitional period, empowerment and self-efficacy, caregiver burden, social support, discharge care model, use of health services and adequation, conciliation and adherence to treatment will be assessed . Cox proportional hazards models will be created, and conditional logistic regression models to identify differences between cases and controls.

Expected Results: National Health System will be provided with tools for predicting the risk of readmission useful to clinicians and managers to offer discharge individualized care. The most common characteristics of readmissions and preventable readmissions will be identified, which will be helpful to create specific actions in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted by acute heart failure (de novo and acute decompensated) (International Classification of Diseases, Ninth Revision, Clinical Modification: 428.x; some of the 402.x group), older tan 18 who will accept to participate.

Exclusion Criteria:

* patients who develop HF episodes during admission, if have been admitted for another reason,
* patients transferred from other health centers,
* myocardial infarction or stroke in the 4 weeks prior to admission,
* life expectancy less than one year, for HF at the terminal or cause different from the CI according to the assessment of the study subjects,
* inability to complete the questionnaires or with assistance external (reviewer, family, social) because of sensorineural reason, dementia or ignorance of the language.
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years old
* Acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (DWI)
* Cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer.
* with informed consent from the patient or next-of-kin, When the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject.

Exclusion Criteria:

* Patients with primary intracranial malignancy
* Patients with classic causes of cerebral infarction
* Patients with infectious or immunological disease that may affect blood D-dimer levels
* Patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue)
* Patients who can not use anticoagulants with thrombocytopenia (platelet \<50,000), anemia (hemoglobin \<8)
* Decreased renal function (creatine clearance \<15 mL / mim)
* Patients who received intravenous tissue plasminogen activator
* Patients with uncontrolled severe hypertension
* Patients who received prosthetic heart valve replacement requiring anticoagulation
* Patients with moderate to severe mitral stenosis
* Pulmonary embolism requiring hemodynamically unstable or thrombolysis or pulmonary embolization
* Pregnant and lactating women
* Patients who are hypersensitive to the major component or constituent of the test drug
* Patients with liver diseases associated with blood clotting disorders and clinically significant bleeding risks
Shoulder Rotational Flexibility and Throwing Arm Injuries of Baseball Pitchers

The evaluation of any relationship between the rotational resistance of the shoulder and shoulder flexibility with throwing arm injuries in professional and college level pitchers.


Eligibility Criteria:
Inclusion Criteria:

* Currently competing
* Healthy pitching arm

Exclusion Criteria:

* Inactive status
* Previous injury
A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence

This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.


Eligibility Criteria:
Inclusion Criteria:

* male adult
* has a pregnant partner
* at least smoke 1 cigarette per day on average in the last month
* be able to read or communicate in Chinese

Exclusion Criteria:

* be or was participated in other smoking cessation program in the past year
* mentally or physically unable to communicate with
* can't play videos by electronic devices
* the pregnant partner is a smoker
Latin America Hip Fracture Mortality Study

The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults 60 years and older
* Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation
* Primary surgical fracture treatment within 10 days after trauma
* No prior treatment for the fracture
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the clinical investigation according to the CIP
* Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria:

* Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)
* Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
* Active malignancy
* Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)
* Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
* Noncompletion of patient baseline questionnaires
* Prior implant on the fractured hip
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease

Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.

Eligibility Criteria:
Inclusion Criteria:

* severe primary mitral regurgitation due to degenerative mitral valve disease

Exclusion Criteria:

* previous open cardiac surgery,
* indication for concomitant aortic valve replacement,
* left ventricle impairment (ejection fraction \< 40%).
Toothpaste With Sodium Carbonate in Patients With Gingivitis

Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.

Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Systemic diseases.
Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Eligibility Criteria:
Inclusion Criteria:

* an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
* score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
* an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
* unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
* free of major post stroke complications
* able to attend therapy 2 days/week or 4 days/week for 2 weeks
* score at least a 16 on the Mini Mental Status Examination
* able to discriminate sharp from dull and light touch using traditional sensation tests.

Exclusion Criteria:

* hemiparetic arm is insensate
* motor impairments from stroke on opposite side of body
* pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
* Legal blindness or severe visual impairment; 5) Life expectancy less than one year
* Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension \< 40º; passive wrist extension \< 40º; passive elbow extension \<40º; shoulder flexion/abduction \< 80º)
* History of sustained alcoholism or drug abuse in the last six months
* Has pacemaker or other implanted device
* pregnant
Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (NSCLC) cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins), not amenable to curative therapy
* Has completed prior treatment with platinum-based chemotherapy. In the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved EGFR Exon 20 targeted tyrosine kinase inhibitor \[TKI\], or see guidelines such as those from national comprehensive cancer network \[NCCN\] or European society for medical oncology \[ESMO\] for alternative non-platinum-based treatments)
* Life expectancy is projected to be greater than or equal to (\>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed)

Exclusion Criteria:

* Has medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months
* Has leptomeningeal disease that is active or symptomatic
* Symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program)
* Known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies
* Is pregnant or breastfeeding