cyrilzakka/clinical-trials huggingface dataset:
Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers

This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.

PRIMARY OBJECTIVES:

I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.

II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.

III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.

IV. To analyze health care utilization among participants receiving embedded onco-palliative care.

OUTLINE:

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

After completion of study, patients are followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
* Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
* New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
* Patient and caregiver must be able to read and understand consent form
* Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation

Exclusion Criteria:

* Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
* Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
* Patients who are unable to read or understand consent form
* Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted
A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

Patients must have either failed to achieve an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 \[NCT00160602\], or must have completed the entire Week 24 assessment of C87050 \[NCT00160602\] trial.

Exclusion Criteria:

* A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
* A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

This protocol represents the second in human study of TUTI-16, and is being conducted to continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.

HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies.

The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age ≥18 and ≤50 years at Screening
* HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for \>2 months (undetectable HIV plasma viremia), viral set point before ART \>3,000
* CD4+ T-cell count ≥ 500/mm3.

Exclusion Criteria:

* Pregnant/nursing females
* Positive for HBV or HCV
* Acute Herpetic event
* Any clinically significant out-of range laboratory value
* Routine or PRN consumption of immune suppressive medications that the subject is unable or unwilling to discontinue during the study
* Participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.
Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome

The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years and above
2. With severe malaria according to the following ciriteria:
3. A positive blood smear for malaria with P. falciparum mono-infection with parasitemia \> 500 parasites/ul of blood
4. Who according to the attending physician require parenteral treatment and admission for malaria
5. Willing to participate in the study
6. Who are or whose first degree parents/caretakers are able to provide written informed consent

Exclusion Criteria:

1. Patients with history of prior antimalarial use within the last 72 hours
2. Pregnant women
3. Patients with contraindications to taking the study drugs
4. Patients taking known inhibitors or inducers of cytochrome P450 -
Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to the stomach) will produce greater weight loss and better reduction of co-morbidities (diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24 months.

The patients will receive standard laparoscopic adjustable gastric banding treatment as well as truncal vagotomy. The vagus nerves will be cut just below the diaphragm using the same access ports that are used during the laparoscopic adjustable gastric banding. During the surgical procedure, the first fifteen patients will also receive a dose of Baclofen, a vagus nerve stimulant, and an endoscopy at the end of the procedure during which congo red dye will sprayed within the stomach. The Baclofen and endoscopy are used to ensure that all branches of the vagus nerve have been cut. If, after 15 complete vagotomies, are verified by the above testing then the use of Baclofen and endoscopy will be abandoned.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient between 18 to 60 years of age.
2. Patient has body mass index (BMI) between 40 to 50 or a BMI between 35 to 40 with one or more co-morbidities , and a stable weight for the last 3 months (+ 3 kg).
3. Female patients must be willing to use contraceptive methods during the course of the trial (18 months).
4. Patient must be motivated to lose weight.
5. Patient has a history of at least one professionally supervised 6 month attempt to lose weight or more than two serious attempts.
6. Patient must be fully ambulatory.
7. Patient is to sign and be given a copy of the written informed consent form. -

Exclusion Criteria:

1. History or signs of prior gastric or esophageal surgery
2. History of or signs and/or symptoms of gastro-duodenal ulcer disease.
3. Participation or plans for participation in another investigational study during the study period.
4. Patients with large hiatal hernias. -
Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal

This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.

The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.


Eligibility Criteria:
Inclusion Criteria:

* Currently using Nexplanon and requesting removal
* Qualifies for outpatient removal
* Ability to understand and sign informed consent

Exclusion Criteria:

* Pregnancy
* Any rashes or skin conditions around the insertion site
* Known allergy to lidocaine
* Known allergy to biocompatible plastics or stainless steel
Managing Medication-induced Constipation in Cancer: A Clinical Trial

The purpose of this research is to evaluate the effectiveness of the Constipation Treatment Protocol and to test whether management according to dose of constipation-inducing medications or according to on-going assessment is most effective.

Patients will undergo a baseline assessment during their regular outpatient visit. With their permission, the investigators will audio record this visit for quality control. After the study, the recordings will be erased. Patients will be asked to complete 4 questionnaires. The investigators will collect contact information so that the follow-up assessments can be done by phone.

Eligibility Criteria:
Inclusion Criteria:

* The study sample will consist of patients who are receiving outpatient care at the Moffitt Cancer Center.
* Patients will be identified as those who have a diagnosis of cancer and are being treated with either opioids or vinca alkaloids,
* are adults (or children 18-21 years old),
* either male or female,
* able to read and understand English,
* and able to pass screening with the Short Portable Mental Status Questionnaire and Karnofsky Performance Status Scale.

Exclusion Criteria:

* Patients will be excluded: if they have non-melanoma skin cancer or colorectal or gynecological cancer as their primary diagnosis;
* if they are excessively debilitated or deemed unlikely to survive for the eight weeks of the data collection period;
* if they are unable to read and understand English;
* if they have an ostomy that changes bowel function;
* if they have a current peritoneal catheter;
* if they have had abdominal surgery within the past six weeks;
* or have a disease process suggestive of mechanical obstruction (tumor or adhesion);
* if they have a history of chronic bowel disease (including irritable bowel syndrome, chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or diarrhea as a result of radiation to the pelvis), or report chronic laxative use prior to cancer onset.
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.

A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.


Eligibility Criteria:
Inclusion Criteria

1. Male or female patients, age between 16 and 70 years, inclusive.
2. Sustained a closed \[non-penetrating\] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;
3. TBI diagnosed by history, clinical examination with GCS of 12 or less.
4. Evidence of TBI confirmed by abnormalities on CT scan
5. Clinical indication to monitor ICP
6. Informed consent is given.

Exclusion Criteria

1. Any spinal cord injury;
2. Pregnant or lactating women;
3. Patients with penetrating head injury;
4. Bilaterally fixed dilated pupils at the time of randomization;
5. Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;
6. Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function);
7. Known treatment with another investigational drug therapy within 30 days of injury.
8. Life expectancy of less than 24 hours.
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE

Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).

The aims of this registry are the following :

* evaluate the feasibility of RIJ access for LP implantation;
* confirm the acute and chronic safety of RIJ access for LP implantation;
* compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;
* evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.


Eligibility Criteria:
Inclusion Criteria:

* Indication of pacemaker implantation
* Eligible to leadless pacemaker

Exclusion Criteria:

* Contraindication to right internal jugular vein access
* Age \< 18 year-old
* Patient already included in a clinical study
Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction

Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial infarction) is a common cause of death. It is well documented that sudden cardiac death after a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is a measure of beat-to-beat changes in heart rate, with a greater variation associated with a "healthier" heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the effect of coffee or tea on HRV after MI.

120 post MI patients on CCU will be studied during the first week of admission. Patients will be categorised using the following criteria: Infarct size and site; PMH; Co-morbidities; Drugs; Regular caffeine ingestion.

Patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea during admission. HRV will be assessed by non-invasive Holter-monitoring on the fifth day. Salivary caffeine concentration will be assessed concurrently to assess compliance.

Eligibility Criteria:
Inclusion Criteria:

* ST-segment elevation (trans-mural) MI; sinus rhythm.
* Age \< 80 years.

Exclusion Criteria:

* Cardiogenic shock
* Nothing by Mouth (NBM)
* Caffeine intolerance
* Atrial fibrillation, temporary or permanent pacing
* Complete heart block, bundle branch block, severe left ventricular impairment, non-ST segment MI/acute coronary syndrome
Electronic Chromoendoscopy for Polyp Characterization

To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing screening or surveillance colonoscopy
* written informed consent

Exclusion Criteria:

* inadequate bowel preparation
* polyposis syndromes
* history of colectomy
* use of anticoagulants
Improving the Outpatient Referral Process With Electronic Communications

An electronic referral application will be developed and integrated into the existing outpatient information system. The primary goal of this software is to improve the quality and coordination of patient care by increasing physician-to-physician communication. The investigators anticipate that improved communications will also enhance physician and patient satisfaction and provide cost savings. These outcomes will be formally evaluated following implementation of the application.

A trial will be performed to test and quantify the benefits of electronic referrals. Primary care physicians (PCPs) from 2 community-based clinics will be recruited for enrollment. The control group will initiate referrals using the pre-existing paper forms; physician-to-physician communication can occur by e-mail, phone, or mail at the discretion of the referring physician as is currently the standard. Physicians randomized to the intervention arm will be asked to use the electronic application for every referral during the study period. For 6 months, every new referral initiated within the study groups will be assessed for the completeness of patient information and timing of feedback to the referring physician via physician surveys. In addition, a subgroup of patients in the control and intervention arms will be surveyed to assess the impact of the intervention on patient satisfaction with the referral process.

Eligibility Criteria:
Inclusion Criteria:

* Any referral initiated by a PCP at the study sites for a patient to go to a specialist for the first time

Exclusion Criteria:

* Referrals for repeat specialist visits or referrals not initiated by a PCP
Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old

The aim of the investigator's study was to investigate translating the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old and using it in clinics reliably and validity with a Turkish version of the PedsQL Generic Core (Pediatric Quality of Life Questionnare) in children with Spinal Muscular Atrophy in Turkey

The PedsQL 3.0 Neuromuscular Module for 2-to 4- year-old will be translated into Turkish by following the language translation steps. First of all, the English form will be translated into Turkish by two people who are fluent in English. Then, the forms translated by another expert in the field will be reviewed. The revised text will be translated from Turkish into English by another person with a good command of English and will be compared with the original scale by the lecturer. If a significant change in meaning is not detected, the scale will be applied to 10 parents. In case of incomprehensible questions, which are reported to be lacking in expression, the scale will be finalized after revision and corrections are made by the research team.

Eligibility Criteria:
Inclusion Criteria:

* Having a child with spinal muscular atrophy
* Having a child between the ages of 2-4
* Accept to participate in the study

Exclusion Criteria:

* Lack of cooperation during work
* Presence of disease other than SMA, which will prevent participation in the study
Korean Post-marketing Surveillance for Onglyza®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who are at least 18 years of age
* Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea

Exclusion Criteria:

* Indication which is not approved for Onglyza® in Korea
* Patients with contraindication for the use of Onglyza® (as clarified in Korean label)
Health Effects Following Use of Lead Free Ammunition Used With HK416

The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* active respiratory disease
REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion

The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for a LAA occlusion device and treated with a commercially available device according to international and local guidelines and per physician discretion.

Exclusion Criteria:

* None