cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer.

The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

The objectives are:

• To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Eligibility Criteria:
Inclusion Criteria:

* Either gender greater than or equal to 18 years of age.
* Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
* Biliary obstruction
* Blocked self expanding mesh metal stent (SEMS)
* Subjects capable of giving informed consent
* Life expectancy of at least 3 months

Exclusion Criteria:

* Cardiac Pacemaker
* Patient unstable for endoscopy
* Inability to give informed consent
* Uncorrected coagulopathy
An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS.
* Stable CMV retinitis.
* Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.
* No permanent central IV catheter at present.
* Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.
* Consent of guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Require continuation of concomitant medications precluded by this protocol.

Concurrent Medication:

Excluded:

* Intravitreal anti-CMV treatment.
* Any other concomitant medications precluded by the protocol.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.
Omega 3 Lipid Emulsions and Liver Transplantation

The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.

Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .

A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration

Eligibility Criteria:
Inclusion Criteria:

* All liver transplant recipients

Exclusion Criteria:

* Budd chiari
* Previous upper abdominal surgery
* Re-transplantation
* Known allergy to the study emulsion
The Clinical Efficacy of Immunomodulators in RA Patients

This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.

In this study cohorts, naïve or csDMARDs-IR patients are treated with different csDMARDs combination or TNF inhibitors for 24 weeks to get remission in clinical. The biomarkers in their plasma and synovial fluid and tissue specimens from RA patients are screened to predict the efficacy of specific treatment.

Eligibility Criteria:
Inclusion Criteria:

-

1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.

1. ACR 1987 rheumatoid arthritis classification criteria

   1. morning stiffness lasting at least 1 hour (≥6w)
   2. there are 3 or more joint areas swollen (≥6w)
   3. swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)
   4. symmetrical arthrogryposis (≥6w)
   5. hand x-ray changes (at least osteoporosis and joint space narrowing)
   6. positive rheumatoid factor (titer \> 1:32) RA can be diagnosed by meeting 4 of the above 7 items
2. ACR/EULAR 2010 rheumatoid arthritis Classification Criteria

   1. Involved joints

      - 1 large joint (0 points)
      * 2-10 large joints (1 point)
      * 1-3 small joints (with or without large joints) (2 points)
      * 4-10 small joints (with or without large joints) (3 points)
      * more than 10 small joints (at least one small joint) (5 points)
   2. Serological indicators

      * RF and ACPA negative (0 points)
      * RF and ACPA, at least one of which is low titer positive. (2 points)
      * RF and ACPA with at least one high titer positive (3 points)
   3. Acute chronotropic reactants

      * Both CRP and ESR normal (0 points)
      * Abnormal CRP or ESR (1 point)
   4. Duration of synovitis

      * \<6 weeks (0 points)
      * ≥6 weeks (1 point)

        2.Patients with OA who meet the 1995 Classification Criteria for OA and have knee dysfunction 1995 Classification Criteria for Osteoarthritis of the Knee Clinical criteria

        a. Knee pain most of the time in the last 1 month b. Bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement Knee OA can be diagnosed if a+b+c+d or a+b+e is met

        3.Age-sex matched healthy volunteers who checked in our hospital.

        4.Age \> 18 years old;

        5.Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Patients with combined active hepatitis
2. Patients with active tuberculosis
3. Patients withinfection and malignancy
Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.

In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.

The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.

Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Secondary hyperparathyroidism due to Vitamin D deficiency

Exclusion Criteria:

* Cardiovascular disease
* Renal failure
* Liver failure
* Treatment with antihypertensive medication or diuretics
* Treatment with lithium, NSAID or glucocorticoids
* Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day
* Medical treatment for osteoporosis
* Systolic blood pressure below 120 mmHg
* Hypercalcaemia (more than 1,33mmol/L)
* Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis
* Allergic reaction to ACEi or ARBs.
Electronic Cigarettes and Reactivity to Smoking Cues

The purpose of this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues.

Tobacco-related illness causes over 5 million deaths per year in the developed world, and most currently available smoking cessation treatments do not effectively enhance long-term cessation outcomes. Reactivity to smoking cues is one factor associated with relapse vulnerability, which is untreated by cessation aids such as NRT. Combining treatments, which ameliorate both pharmacological nicotine withdrawal and reduce smoking cue reactivity, may enhance smoking cessation success. During this study we will test whether combining NRT with non-nicotine containing electronic cigarettes (e-cigarettes) effectively reduces reactivity to smoking cues. The only source of nicotine participants will receive during the study will come from NRT. We will use e-cigarettes that provide no nicotine, yet may provide a similar experience to smoking as e-cigarettes taste and feel similar to a regular cigarette. However, since nicotine delivery is not associated with the act of smoking the reinforcing effects associated with smoking behavior may be reduced. Reactivity to smoking cues will be assessed using a battery of measures including: self-report, behavioral, and neuroimaging.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. Be aged 18-45.
3. Report smoking cigarettes daily in the past 6 months.
4. Have expired breath CO indicative of regular smoking.
5. Have a score greater than 0 on the FTND.
6. Be willing to use Nicotine Replacement Therapy (NRT) and the e-cigarette for a period of 2 to 3 weeks.
7. Speak and read English.
8. Pass an MRI safety screen and meet inclusion criteria for MRI scans.

Exclusion Criteria:

1. Be pregnant (measured via urinalysis).
2. Meet current abuse or dependence criteria for any substance other than nicotine or caffeine (measured via the SCID 5).
3. Produce a positive urine screen for drugs of abuse or alcohol at the fMRI scan visits.
4. Meet DSM-IV criteria for major depressive episode in the past six months, lifetime DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder or psychotic disorders not elsewhere classified (measured via the SCID 5).
5. Be currently suicidal as assessed by DSM 5 and the Beck Depression Inventory.
6. Current use of medications or any history of a medical condition that might affect the central nervous system at the time of scanning including: Abnormal structural MRI, or a history of head trauma or injury causing loss of consciousness lasting longer than 3 minutes or associated with skull fracture or intracranial bleeding or who had irremovable magnetically active objects on or within their body, history of epilepsy, current use of a beta-blocker or prescription analgesic/anxiolytic. (assessed by self-report).
7. MRI exclusion criteria. (additional information outlined in the "protection of human subjects" section).
8. History of claustrophobia.
9. History of propylene glycol sensitivity/allergy.
Stop Addiction Stigma

This clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. Negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. Using case vignettes with a SAS workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.

PRIMARY OBJECTIVE:

I. To describe the impact of SAS training on participants' responses to people with a substance impairment.

SECONDARY OBJECTIVES:

I. To evaluate the feasibility of stigma training workshops on stigmatizing attitudes health care personnel.

II. To explore the maintainability of responses over time. III. To explore relationships between language and stigmatizing attitudes.

OUTLINE: Participants are randomized to 1 of 6 group case vignettes.

GROUP A (CHRONICALLY RELAPSING BRAIN DISEASE): Participants view the chronically relapsing brain disease vignette and attend a SAS workshop on study.

GROUP B (BRAIN DISEASE): Participants view the brain disease vignette and attend a SAS workshop on study.

GROUP C (DISEASE): Participants view the disease vignette and attend a SAS workshop on study.

GROUP D (ILLNESS): Participants view the illness vignette and attend a SAS workshop on study.

GROUP E (DISORDER): Participants view the disorder vignette and attend a SAS workshop on study.

GROUP F (PROBLEM): Participants view the problem vignette and attend a SAS workshop on study.

Eligibility Criteria:
Inclusion Criteria:

* Employee of Ohio State University Wexner Medical Center (OSUWMC)
* Age ≥ 18 years
* Participants must be able to read and comprehend survey items
Head Positions to Open the Airway IV

After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;


Eligibility Criteria:
Inclusion Criteria:

* male and female patients ≥ 18 years
* elective operations in general anaesthesia
* patient´s written informed consent
* American Society of Anesthesiology scale I-III

Exclusion Criteria:

* non fasting patient
* body mass index \> 35 kg/m2
* anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine
* malformations of the head or upper airway
* history of perforation of stomach or esophagus
* anamnestic hiatus hernia or reflux
* acute respiratory infection or obstructive airway disease
Ultra-wide Diameter Implants in Mandibular Molars

The goal of this \[clinical trial\] is to \[To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket\]

the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.

Eligibility Criteria:
Inclusion Criteria:

Adult patients ranging from 20-40 years.

* Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
* Non-restorable mandibular molar teeth.
* Available bone with adequate width and buccolingual dimensions.
* Peri-implant bone defect should be 2mm or lesser.

Exclusion Criteria:

* Smokers.
* Medically compromised patients like uncontrolled diabetes and coagulation disorders.
* Tooth with periapical pathosis or bony defects.
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss.

Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study.

Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.

Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.

The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.


Eligibility Criteria:
Inclusion Criteria:

- At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment

Exclusion Criteria:

* Frozen spermatozoa
* Frozen oocytes
* women with PCO and PCOS
* women with more than 4 ART treatments
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with primary or secondary myelofibrosis. Approximately 322 eligible patients will be randomized in a 2:1 allocation to pacritinib (400mg QD) or BAT (includes any physician-selected treatment for myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases)). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
* Palpable splenomegaly ≥ 5 cm on physical examination
* Total Symptom Score \>13 on the MPN-SAF TSS 2.0, not including the inactivity question
* Patients who are platelet or red blood cell transfusion-dependent are eligible
* Adequate white blood cell counts (with low blast counts), liver function, and renal function
* No spleen radiation therapy for 6-12 months
* Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or thrombopoietic agent
* Not pregnant, not lactating, and agree to use effective birth control

Exclusion Criteria:

* Prior treatment with a JAK2 inhibitor
* History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
* Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
* Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
* Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
* Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
* Life expectancy \< 6 months
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3

Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.

The study team plans to conduct a randomized clinical trial with three arms: (1) usual care, (2) the simple reminder, and (3) the simple reminder plus the script. Randomization will be carried out at the physician level at each clinical site, to ensure that all three treatment arms are represented in each clinic. The primary outcome, HPV vaccine acceptance, will be assessed for each study participant.

This study will be implemented through the Child Health Improvement through Computer Automation system (CHICA). CHICA is a computer based clinical decision support system that has been operating in the Wishard/Eskenazi system since 2004. CHICA now operates in 5 clinics in the health system and has served well over 37,000 children. CHICA supports primary pediatric care, supporting screening, counseling, anticipatory guidance, vaccinations, and chronic disease diagnosis and management.

CHICA is unique in several respects. These include a unique tailored, scannable paper interface, a prioritization scheme that assures the highest priority reminders are given to physicians, and the ability to collect data directly from families in the waiting room. CHICA acts as a front end to the Regenstrief Medical Record System (RMRS), the electronic medical record for the Eskenazi health system. The RMRS and CHICA communicate using industry standard HL7 communication protocols.

When a patient checks into a CHICA clinic, CHICA receives an HL7 ADT (registration) message. In response CHICA requests a download of the patient's record from the RMRS. CHICA applies a set of Arden Syntax rules to the patient's data to select 20 yes/no questions that are printed. The family answers these questions by checking boxes. The nurse or medical assistant enters height, weight, etc. on the same form and the form is scanned. The data enter CHICA's database through optical mark recognition and optical character recognition. Recently we have begun converting from this scannable paper format to electronic tablets.

Eligibility Criteria:
Inclusion Criteria:

Provider Criteria

* All pediatricians and nurse practitioners who provide health care at the 5 CHICA clinics will be included in this study

Subject Criteria

* Patients will be 11-17 year old
* Males and females
* A visit to at least one of the five CHICA clinics
* Eligible for the 2nd or 3rd dose of HPV vaccine

Exclusion Criteria:

* Patients in the eligible age range who have not started or have completed the HPV vaccine series will be excluded