cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.


Eligibility Criteria:
Key Inclusion Criteria:

* Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
* Onset of persistent symptoms ≤ 2 years prior to screening
* Positive test result for anticyclic citrullinated peptides 2
* Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
* Biologic naive, including no treatment with an investigational biologic prior to screening
* Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
* Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
* If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
* Able to undergo magnetic resonance imaging

Key Exclusion Criteria:

* Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
* Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
* Scheduled for or anticipating joint replacement surgery
* Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
* History of malignancy in the last 5 years
* Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
* At risk for tuberculosis
* Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment
MiVideo - Video Visit Summary for Cancer Patients

Cancer patients about to begin chemotherapy receive large amounts of information regarding their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the chemotherapy during their first visit to the oncologist. Prior studies have documented that less than half of this information is retained after the visit, making it difficult for patients to participate in their care and difficult for them to enlist the help of their social support. The MiVideo project allows the physician to create a custom 5-minute summary video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The video will emphasize the major points of the forty-five minute office discussion, allowing patients to review the physicians' recommendations and share the information and recommendations with others. By providing the patient with this re-cap of their visit, the investigators hope to engage them more actively in their cancer treatment. Making the information available to friends and family can also help a patient receive both intellectual and emotional support during the course of treatment. The primary endpoint of this study is improvement of patient care, not research activity.

Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage, chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as compared to visits that do not include video production.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Diagnosis of colon cancer with treatment plan to include chemotherapy
* Sufficient command of English language to read and understand consent and survey forms
* Working email address and access to the Internet (computer, tablet, smartphone) to view treatment summary video

Exclusion Criteria:

* Previous history of chemotherapy or cancer (excepting in situ cancers)
* History of drug or alcohol abuse or unmedicated mental or psychiatric disorder
* Medical history or diagnosis of debilitating medical disorder such as progressive muscle paralysis, advanced cardiac, respiratory, or renal disease, or AIDS
Interprofessional Collaborative Communication in Acute Care Hospital Teams

Collaborative practice may improve patient outcomes in specific disease conditions and health care settings. The SCRIPT Programme is an intervention to implement informal, but structured, communication etiquette between members of interprofessional ward-based clinical teaching units (CTUs) in General Internal Medicine (GIM) hospital divisions.

A recent literature review commissioned by Health Canada for the Inter-Professional Education for Collaborative Patient-Centred Practice initiative (IECPCP) reported evidence that collaborative practice improves patient outcomes in specific populations. Interprofessional collaborative teaching and practicing are poorly articulated in the literature, however. Studies are needed that can develop a trial-based body of evidence to support education and practice of effective interprofessional care.

The SCRIPT project will attempt to develop sustainable transformation in the conduct, learning and evaluation of interprofessional teamwork in the Toronto Academic Health Science Network (TAHSN). SCRIPT has investigated interprofessional work relations in general internal medicine units at TAHSN hospitals using fieldwork observations and interview methods. These data were foundational for SCRIPT's design of a unit-based staff intervention intended to promote more--and more-effective--informal interprofessional communication and collaboration between GIM staff members outside of traditional, structured meeting times like morning report and bullet rounds.

The intervention is designed as part of a pragmatic trial. We will ask GIM division staff of intervention teams to implement a 4-step communication protocol in face-to-face, patient-related interaction. The steps are:

1. introduce oneself by name;
2. state one's role or responsibility in relation to the patient under discussion;
3. describe the issue, problem, or plan relating to the target patient;
4. elicit feedback from the other participant(s) in the interaction with a prompt, e.g., "do you have any concerns," or, "is there something else I should consider?"

The intervention will be evaluated as a cluster randomized controlled trial among five large Toronto (Canada) teaching hospitals. Two medical clinical teaching units and associated ward teams of nurses and other health professionals from each hospital's GIM division will be allocated at random to enact the intervention. Two other GIM CTUs in each hospital will continue their usual interprofessional practice, without intervention. In total, there are 20 CTUs, 10 in the treatment group and 10 in the control group. Intervention CTUs will be compared with control CTUs on the outcomes of interest.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to divisions of General Internal Medicine
* Health care providers working in divisions of General Internal Medicine
Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travellers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).

Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale=VAS, Health Assessment Questionnaire Disability Index = HAQ, Disease Activity Score =DAS-28, CRP and total IgG in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG \> 10mIU/mL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* TNF-alfa blocker and / or methotraxate in use as a medication against RA
* A desire to get protected against hepatitis A
* Men and women age 18-65 years
* Written informed consent
* Women of childbearing potential must use effective contraception -

Exclusion Criteria:

* Treatment with rituximab within 9 months before study start
* Known previous hepatitis A infection
* Previous vaccination against hepatitis A
* Allergy to eggs or formaldehyde
* Pregnancy or lactation
* Excessive use of alcohol
* Mental retardation
* Acute disease at the time of examination (fever \> 38 degrees)
* Volunteer works as an employee of the researchers
* Previous vaccination against hepatitis A
* Egg-, henprotein- or formaldehyde allergy
* Pregnancy or lactation
* Excessive use of alcohol
* Another vaccine given within a month
* Acute disease at the time of examination (fever \> 38 degrees)
* Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)
UCSF College Health Study on Contraceptive Training and Education at Community Colleges

The purpose of this study is to measure whether a training and education intervention for clinic staff and young women aged 18-25 on contraceptive methods, including intrauterine devices (IUDs) and the implant, will result in greater contraceptive knowledge and access among students in community colleges.

In the US, young women aged 18-25 years have limited knowledge of contraception or pregnancy risks and often experience challenges in accessing reproductive health care. They have little familiarity with the full range of contraceptives, particularly long-acting reversible contraception (LARC) including the IUD and implant. This campus-level, multiple component intervention provides evidence-based contraceptive training and education to clinic staff and students in this age group attending community colleges in California and Texas.

Eligibility Criteria:
Inclusion Criteria:

This study involves two groups of human subjects: students at 28 community colleges and staff at the student health center and referral clinics.

Students must be:

* Female;
* Age 18-25;
* Speaks English;
* Sexually active (vaginal sex with a male partner) in the last year;
* Not currently pregnant;
* Does not want to become pregnant in the next 12 months;
* At risk of pregnancy (including not sterilized);
* Enrolled in the current term at the participating community college;
* First-time college students, meaning no college enrollment prior to the current academic year; and
* Willing to be contacted by email and telephone over the next 12 months.

Clinic staff must:

* Be employed by a participating clinic; and
* Offer clinical care, counseling or education for contraception at the clinic.

For colleges to be eligible to be study sites, they must:

* Be an accredited community college;
* Not share health center staff with a participating college site;
* Have no active LARC intervention; and
* Enroll students ages 18-25 years.

Exclusion Criteria:

* Students and clinic staff will be excluded if they do not meet the inclusion criteria.
Fenretinide in Treating Children With Solid Tumors

Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors.

II. Determine the toxicities of HPR in these patients. III. Determine the pharmacokinetics of HPR in these patients. IV. Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study.

V. Determine the effect of HPR on plasma retinol levels in these patients. VI. Determine the activity of HPR in these patients. VII. Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma.

OUTLINE: This is a dose escalation study.

Patients receive oral fenretinide 3 times a day on days 1-7. Treatment repeats every 3 weeks for up to 8 courses. Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor. Patients with recurrent neuroblastoma, after prior myeloablative therapy with no measurable disease, will stop treatment after 8 courses. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed until death.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant solid tumor that is refractory to conventional therapy or recurrent neuroblastoma treated with myeloablative therapy and autologous stem cell transplant in second complete or partial response
* Bone marrow metastases with granulocytopenia, anemia, and/or thrombocytopenia are eligible

PATIENT CHARACTERISTICS:

* Age: Under 21 at diagnosis
* Performance status: CCG 0-2
* Life expectancy: At least 2 months
* Absolute neutrophil count at least 750/mm3
* Platelet count at least 50,000/mm3
* Hemoglobin at least 7.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT less than 2.5 times normal
* Creatinine no greater than 1.5 g/dL OR creatinine clearance at least 50 mL/min OR radioisotope GFR at least 50 mL/min
* Seizure disorders controlled with anticonvulsants allowed
* No CNS toxicity greater than grade 2
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* At least 1 month since prior autologous stem cell transplantation
* No prior allogeneic transplantation
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered
* No other concurrent chemotherapy
* No concurrent immunomodulating agents (including steroids)
* Concurrent corticosteroid therapy for increased intracranial pressure allowed
* Concurrent dexamethasone for CNS tumor allowed
* At least 2 weeks since prior radiotherapy
* Concurrent radiotherapy to localized lesions allowed
* At least 2 weeks since prior retinoids Prior isotretinoin or 9-cis-retinoic acid allowed
Simulated-based Program for Peripheral Nerve Blocks in Anesthesia Residents

The goal of this Simulated Based Program for Peripheral Nerve Blocks is build learning curves in anesthesia residents.

The research questions are:

How behave the learning curves in a simulate based training program in peripheral nerve blocks in anesthesia residents? Does the learning achieved during the program transferred to the real patient's scenario?

Participants will be subjected to 10 simulated training sessions of a sciatic popliteal nerve block, subsequently their performance will be recorded and a global scale will be applied and movements will be measured. In a second stage, the same subjects will perform a block on a real patient to determine the transfer of this simulated learning.


Eligibility Criteria:
Inclusion Criteria:

- Anesthesia first year residents

Exclusion Criteria:

* Previous regional anesthesia rotation
* Previous training in ultrasound guided punction
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation

In patients with acute rejection after lung transplantation the peptide profile in broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm that allows an non-invasive rejection therapy.

Goal of the study is the establishment of biomarkers for early diagnosis of acute rejection, followed by a late validation of the paradigm with prospectively collected samples, which will be examined blinded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable graft function
* Patients with acute rejection

Exclusion Criteria:

* Acute infection
* BOS
Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults

Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.

Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. This research will provide an initial first step towards answering the following three research questions:

1. Does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression?
2. Does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population?
3. Are changes in dysmetria and balance control correlated with a change in depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* You are over the age of 18.
* You have been diagnosed with depression.
* You are currently taking medication for depression or have previously taken medication.
* You have been or were on your depression medication for at least 3 months.
* You feel/felt that the medication is/was not helping.

Exclusion Criteria:

* Had a lifetime history of severe neurologic or mental illness (e.g. schizophrenia or substance abuse)
* Are pregnant
* Have pending litigation or a recent history of spinal fracture, metastatic cancer, chiropractic care within the past month
* Present with contraindications to chiropractic care
The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients; Surgical Fear, Anxiety and Comfort.

Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.

Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.

In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.

This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised in surgical wards and undergoing cholecystectomy,
* Patients who voluntarily agree to participate in the study will be included.

Exclusion Criteria:

* Mental retardation and any psychiatric disorder,
* Alcohol and drug addiction,
* Dementia, Alzheimer's disease etc. affecting cognitive functions,
* Patients who will undergo other operations other than cholecystectomy surgery.
Telerehabilitation Program and Detraining in Patients With Post-COVID-19 Sequelae

The primary objective of this study is to evaluate the effects of a 15-week home telerehabilitation program and a detraining period on cardiorespiratory fitness and muscular efficiency in patients with post-COVID-19 sequelae compared to a control group of COVID-19 patients. We hypothesize that cardiorespiratory fitness and muscular efficiency significantly improve in patients who carry out the home telerehabilitation program. However, the cardiorespiratory and muscular adaptations achieved and tolerance to exercise are lost over time as an effect of detraining.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* molecular diagnosis (reverse transcription polymerase chain reaction \[RT-PCR\]) of infection by SARS-CoV-2
* post-COVID-19 symptomatology

Exclusion Criteria:

* severe neurological disease
* active oncological disease
* neuromuscular disease and/or orthopedic disorders impeding normal development of cardiopulmonary exercise test
* the absence of signed informed consent
A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment

The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.


Eligibility Criteria:
Inclusion Criteria:

* at least 8 oocytes retrieved at pickup
* oocyte insemination with ICSI technique
* only elective single embryo transfer (eSET) at blastocyst stage
* sperm concentration ≥ 1 X 106 /ml
* absence of antibiotic treatment in the previous four weeks for male patients

Exclusion Criteria:

* recurrent miscarriages
* more than three in vitro fertilization treatment
* azoospermia
AXIOS Stent With Electrocautery Enhanced Delivery System

The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years old, male or female
2. Eligible for endoscopic intervention
3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
4. Symptomatic pancreatic pseudocyst having the following characteristics:

   * Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound).
   * Adherent to bowel wall, and
   * ≥70% fluid content
5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion Criteria:

1. The fluid collection to be drained is an immature pseudocyst
2. The fluid collection to be drained is a cystic neoplasm
3. The fluid collection to be drained is a pseudoaneurysm
4. The fluid collection to be drained is a duplication cyst
5. The fluid collection to be drained is a non-inflammatory fluid collection
6. There is more than one pseudocyst requiring drainage
7. Abnormal coagulation:

   * INR \> 1.5 and not correctable
   * presence of a bleeding disorder
   * platelets \< 50,000/mm3
8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
12. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.