cyrilzakka/clinical-trials huggingface dataset:
Oral Health Recovery Group

The aim of the study is to test a brief, peer-led group-based oral health educational intervention - called the "Oral Health Recovery Group" - designed for individuals with psychiatric disabilities.

Participants at each site will obtain either: a) a Peer-led Oral Health Recovery educational group, representing the primary intervention; or b) viewing of an educational video about oral health, representing the comparison intervention. After participating in either condition, an onsite Peer staff member will offer to help the participant make a dentist appointment. They will follow up with the participant as needed for a two-month period to help arrange dental care and follow up on any dental self-care goals established by the participant, such as purchasing toothpaste with fluoride.

Eligibility Criteria:
Inclusion Criteria:

* An adult member/consumer with the selected site (JIMHO or Washtenaw CMH)
* Ability to understand and willingness to read a consent terms handout and discussion
* Participant must understand/read/speak English

Exclusion Criteria:

* Not a member/consumer with the site
* Not able to understand and/or not willing to read consent terms handout
* Does not understand/read/speak English
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers

This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 50 to 69 years of age
* Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
* Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
* Seronegative for human immunodeficiency virus (HIV)

Exclusion Criteria:

* History of HZ
* Previous vaccination against varicella or HZ
* If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
* Known history of HIV (HIV 1/2 antibodies)
* Has a history of sensitivity to any component of study vaccines
* Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period
* Has received the following prior to the first injection:

  * 14 days: any non-live vaccine
  * 28 days:
  * Any live vaccine, including a COVID-19 vaccine
  * Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
  * Granulocyte or granulocyte-macrophage colony-stimulating factor
  * Any other investigational medicinal agent, including a COVID-19 vaccine
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
* Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* History of autoimmune disease
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

This is a randomized trial investigating whether continuous norepinephrine administration via an infusion pump - compared to manual bolus administration - increases blood pressure stability within the first 15 minutes of anesthetic induction in non-cardiac surgery patients.

The secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg \[mmHg × min\], cumulative duration of a MAP \<65, \<60, \<50, and \<40 mmHg \[min\], area above a MAP of 100, 110, 120, and 140 mmHg \[mmHg min\], cumulative duration of a MAP \>100, \>110, \>120, and \>140 mmHg \[min\] and cumulative dose of norepinephrine indexed to body weight \[μg/kg\] within the first 15 minutes of anesthetic induction will be assessed.

not provided

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 45 years
* American Society of Anesthesiologists physical status II-IV
* scheduled for elective major non-cardiac surgery under general anesthesia
* continuous intraarterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the trial
* sinus rhythm

Exclusion Criteria:

* Clinical indication to use a continuous norepinephrine infusion via an infusion pump during anesthetic induction
* Need for femoral artery catheterization
* History of intracranial bleedings or aneurysms
* Patients who are incapable of giving consent
* Pregnancy
An Evaluation of Home-Based Telemedicine Services

Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.

Background:

Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.

Objectives:

The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.

Methods:

Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.

Status:

The study is completed, with a final enrollment of 37 patients. Three study manuscrip\[ts have been completed (two published and one under review).

Eligibility Criteria:
Inclusion Criteria:

Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.

Exclusion Criteria:
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B

To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including:

1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the incidences of adverse reactions under the routine drug uses.

3) Factors that may affect the safety of the drug 4) Factors that may affect the effectiveness of the drug

The patients who meet the inclusion criteria will be enrolled consecutively.

Eligibility Criteria:
Inclusion Criteria:

* Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
* Pediatric and adult patients who have been treated with original or reformulated BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for example, patients switching from pdFIX to BeneFIX).

Exclusion Criteria:

* Patients with a known history of hypersensitivity to original or reformulated BeneFIX or any component of the product.
* Patients with a known history of hypersensitivity to hamster protein.
* Patients participating in an interventional trial of any investigational drug or device.
Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

Multicenter, single-arm, open phase IIIb, conversion study where a Cyclosporine A-based immunosuppressive regimen is replaced by the administration of tacrolimus modified release formulation, MR4, once daily (morning dosing only) in stable renal transplant subjects. The initial recommended dose of MR4 is 0.1 mg/kg/day.

Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects, hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension.

Stable, adult kidney transplant recipients (≥ 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Serum creatinine \< 200 µmol/l (\< 2.3 mg/dl) at enrollment.
* Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.
* Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).

Exclusion Criteria:

* Previously received an organ transplant other than a kidney.
* Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy
Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)

This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)

Eligibility Criteria:
Inclusion Criteria:

* The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
* The participant must have bilateral MacTel;
* Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
* Participant must be medically able to undergo ophthalmic surgery for ECT implant;
* The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

Exclusion Criteria:

* Participant is \< 21 years of age;
* Participant is medically unable to comply with study procedures or follow- up visits;
* Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
* Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
* Participant has evidence of subretinal neovascularization in either eye;
* Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
* Participant has evidence of pathologic myopia in either eye;
* Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;
Modified Paramedic Sagittal vs. Transverse TMQLB

The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB) approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread for PVS. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent
* Able to cooperate with study process

Exclusion Criteria:

* Allergy to local anesthetic and other medications used in the study
* Patient refusal or lack of informed consent
* Coexisting hematological disorder or with deranged coagulation parameters
* Pre-existing major organ dysfunction such as hepatic and renal failure
* History of previous renal surgery.
The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care

Telephone medical advice in general practice is expanding. The Cochrane Database concludes in 2008 that there is not enough data about its use regarding out-of-hours general practitioners workload, emergency department visits, cost, safety and patient satisfaction. The aim of this study is to assess the effectiveness of telephone medical advice given by a general practitioner in a call centre for patient presenting isolated fever or gastroenteritis symptoms.

This is a prospective, open label, cluster randomized trial of 2 880 expected patients who calling a French emergency medical service Dial 15 for fever or gastroenteritis symptoms during out-of-hours periods. All calls will be taken by a general practitioner (GP). Out-of-hours period is defined as 8 PM to 8 AM on weekdays, 1 PM to 8PM on Saturdays in addition to Sundays and holidays.To be exhaustive, we will enrol patients during one year.

In the experimental arm, the GP will implement a protocol of care to each patient call. The protocol includes medical advice, drug prescription by phone and supervisory board. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their GP during working hours.

In the non-interventional arm, the GP will decide the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.

We will recall every patient at 15+/-4 days.

Eligibility Criteria:
Inclusion Criteria:

* Disease:

  * Fever: temperature ≥ 38 ° C
  * Symptoms of gastroenteritis include nausea and / or vomiting and / or diarrhea
* Onset of symptoms for less than 72 hours
* Age ≥ 18 years caller
* Patient age ≥ 1 year
* Affiliation to the French National Health Service

Exclusion Criteria:

* Pregnancy
* Severity criteria (fever\> 41 ° C, disturbance of consciousness, rash, dyspnea, signs of dehydration, chest pain, neurological signs, gastrointestinal bleeding)
* Seeking advice from institutional correspondents (fire brigade, police, airport...)
* Communication difficulties (non-communicating patient, language barrier...)
Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP

Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further improve the treatment for gastric cancer in this population. Recently reported phase III study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy, the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol 22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer. The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient population.

Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of 67.5% (95% confidence interval, 52.7 \~ 82.3) in intention-to-treat analysis. Ten patients underwent surgical resection after 4 \~ 9 cycles of chemotherapy. Four pathologic CRs were identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented gastric adenocarcinoma
* Age 18 -70
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Pathologic stage IIIB or IV
* complete resection (R0 resection)

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* R1 or R2 resection
* Presence of distant metastasis
* Gastric outlet obstruction or intestinal obstruction
* Evidence of gastrointestinal bleeding
* Other serious illness or medical conditions
OPTIONS Spinal Cord Stimulation Programming Parameters

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.

The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
* Willing and able to provide a signed and dated informed consent
* At least 18 years old at the time of informed consent
* Willing and able to attend visits and comply with the study protocol
* Capable of using the patient programmer and recharging the neurostimulator
* Willing to not increase pain medications from baseline through the 3-Month Visit

Exclusion Criteria:

* Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
* Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
* Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
* Implanted with a cardiac device (e.g., pacemaker, defibrillator)
Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Eligibility Criteria:
Inclusion Criteria:

- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL).

Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent

Exclusion Criteria:

- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome