cyrilzakka/clinical-trials huggingface dataset:
Does Islet Transplantation Eliminate Hypoglycemia?

Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease

Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI

Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.

Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.

Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.

Biopsies will be taken of all those lesions detected, instead of random biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy

Exclusion Criteria:

* Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
* Known allergy or intolerance to methylene blue
* Pregnant or lactating women
* Personal history of colorectal cancer
* Ulcerative colitis active more than 20 cm from the anal verge
* Patients with known G6PD deficiency
* Severe kidney failure
MDR - Biomet Cannulated Screws

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.

Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.

All patients operated on for the following indications:

* Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:

  1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
  2. Arthrodesis of the foot, wrist and elbow.
  3. Small and long bone osteotomies.
  4. Fracture fixation of small bones, small bone fragments and long bones.
* Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:

  1. Fixation of fractures in long bones and long bone fragments.
  2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
  3. Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
* Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:

  1. Slipped capital femoral epiphysis
  2. Pediatric femoral neck fractures
  3. Tibial plateau fractures
  4. SI joint disruptions
  5. Intercondylar femur fractures
  6. Subtalar arthrodesis
  7. Fixation of pelvis and iliosacral joint
* Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
* Patient must have a good nutritional state.

Exclusion Criteria:

* Infections.
* Patient conditions including blood supply limitations, insufficient quantity or quality of bone.
* Patients with mental or neurologic conditions who are unwilling or incapable fo following postoperative care instructions.
* Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient is known to be pregnant or breastfeeding.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
Completely Versus Partially Guided Zygomatic Implant

The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.

According to World Oral Health Organization (WHO), losing teeth and arch edentulism is the result of a life long history of oral diseases like advanced dental caries and severe periodontal disease. Complete tooth loss estimated global average prevalence is 7% among people aged 20 years and 23% among people aged 60 years or older. Tooth loss lead to bone resorption in all direction.

Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants.

Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides.

Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted.

In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years.
2. Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).

Exclusion Criteria:

1. Patients with systemic conditions contra-indicating general anesthesia.
2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
4. Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;
* Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;
* Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);
* Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
* Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit.

Exclusion Criteria:

* Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
* Has a history of coronary revascularization (percutaneous coronary intervention \[PCI\] and/or coronary artery bypass graft \[CABG\]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);
* Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;
* Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
* Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
* Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine equation) at the Screening Visit.
Investigating Sedentary Time in Aging: New Directions

The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting. The goal of the study is to find out if using commercially available devices are helpful in reducing sitting time.

To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.

The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* BMI of 25+
* Ages 60+
* Continuously enrolled at Group Health for previous 12 months
* No record of death
* Not on the No Contact list
* Speaks, reads, and writes English
* Able to hold a conversation by phone (no hearing or other limitations)
* Self-reported ability to stand
* Self-reported ability to walk one block unassisted
* No history of an injury from a fall in past 3 months
* Work or retirement situations allows for taking breaks from sitting throughout the day
* Available for the study duration
* No unusual activities planned (e.g. travel, moving) during the study period
* Able to come to Group Health Capitol Hill/Central for measurement visits
* Willing to wear activity monitor (activPAL)
* Self-reports taking less than 4 breaks from sitting during an average hour
* Self-reports sitting more than 7 hours per day

Exclusion Criteria:

* Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
* Wheelchair bound
* Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
* Use of an assistive device
Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer

RATIONALE: Studying changes in thymus function in patients who have been undergoing androgen blockade therapy for prostate cancer may help doctors learn more about how well patients will respond to treatment, may help in planning cancer treatment, and may help the study of cancer in the future.

PURPOSE: This clinical trial is studying the effect of androgen blockade therapy on thymus function in older patients who have undergone radical prostatectomy for localized prostate cancer.

OBJECTIVES:

* Determine if inhibition of sex steroid action is associated with increased thymic size in older patients who have undergone radical prostatectomy for localized adenocarcinoma of the prostate.
* Determine if inhibition of sex steroid action is associated with an increase in the absolute number or percentage of circulating "naive" phenotype T cells, and/or an increase in the frequency of T-cell receptor excision circles in peripheral blood cells.

OUTLINE: This is a nonrandomized, single-blind, cohort study. Patients are stratified according to hormonal therapy after surgery (yes vs no).

Patients undergo CT scan of the thymus. Blood samples are analyzed by flow cytometry to determine phenotype of T cells.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate
* Underwent prior radical prostatectomy as local definitive therapy for prostate cancer
* Meets criteria for 1 of the following strata:

  * Has received ≥ 9 months of androgen blockade therapy (either single-agent luteinizing hormone-releasing hormone or combined androgen blockade) for serologic progression after surgery

    * Serologic progression defined as a rising prostate-specific antigen, which has risen serially on two determinations (from baseline) ≥ 1 week apart, and no objective evidence of metastatic disease
    * Prior radiotherapy for serologic progression allowed
  * Did not receive any form of androgen blockade therapy within the past 9 months
* No metastatic disease by abdominal/pelvic CT scan and whole-body scan

PATIENT CHARACTERISTICS:

* Able to tolerate CT scanning in the supine position
* No prior medical condition known to have effects on the thymus, including myasthenia gravis, lymphoma, hyperthyroidism, or cachexia
* No autoimmune disorders
* No acute illness, including active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior systemic chemotherapy
* No prior immunological therapy
* No prior single-agent antiandrogen (e.g., high-dose bicalutamide)
* No prior or concurrent 5-alpha reductase inhibitors (e.g., finasteride), PC-SPES, or estrogen-containing nutraceuticals
* No concurrent systemic steroid therapy (topical steroids allowed)
Apixaban in Subjects With Peritoneal Dialysis

The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.

Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.

Eligibility Criteria:
Inclusion Criteria:

* Participant with 21\<BMI\<40
* French participant
* Participant able to consent
* Participant with social insurance
* Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated

Exclusion Criteria:

* Participant with hypersensibility reactions to apixaban
* Participant with a history of major bleeding
* Participant already on anticoagulant
* Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage \> 300 mg
* Participant on potent inhibitors of CYP 3A4 and P-gp
* Participant on inducers of CYP3A4 and P-sp
* Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
* Participant receiving or having received antibiotic treatment within 14 days prior to study
* Pregnant or lactating women
* Participant with known hypersensitivity reactions to icodextrin
* Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)
* Participant with "Normal renal function" with glomerular filtration rate \< 90 ml/min
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®

We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)

Prospective, open-label, single-arm, non-randomized, multi-center study designed to evaluate the effect of the antibiotic rifaximin on the regional composition of the gut microbiota and metabolic profiles of subjects diagnosed with SIBO, using the CapScan collection capsule.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit.
* ASA Classification 1 or 2.
* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit.
* Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
* Positive for at least one clinical symptom consistent with SIBO.
* Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
* Prescribed, but has not started, a two-week course of Rifaximin for SIBO.

Exclusion Criteria:

* History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
* Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
* A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Evaluation of RC28-E Injection in Diabetic Macular Edema

This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
* Aged 18 years to 80 years, male or female;
* Diabetes mellitus(type 1 or 2);
* The study eye must followed:

  1. Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea; Decrease in vision determined to be primarily the result of DME and not to other causes.
  2. BCVA score in the study eye of 73 to 24 using the ETDRS protocol at an initial testing distance of 4 meters.
  3. The central subfield thickness ≥300μm in the center subfield as assessed on OCT by the reading center;
* If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye; the researchers judged that the fellow eye should not be treated with other anti-VEGF drugs recently.

Exclusion Criteria:

* The macular edema caused by others instead of diabetes mellitus;
* Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates;
* Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involving the macula in the study eye;
* Only one functional eye even if that eye is otherwise eligible for the study;
* Evidence of periocular or intraocular inflammation or infection including infectious blepharitis, keratitis, scleritis, conjunctivitis, endophthalmitis or uveitis at screening assessment in either eye;
* Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0;
* History of cardiovascular and cerebrovascular events within 6 months of screening visit: myocardial infarction, unstable angina pectoris, ventricular arrhythmias, New York heart association grade II + heart failure, stroke, etc.;
* Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
* Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before the baseline period;
* Those who considered unsuitable for enrollment by investigator.