cyrilzakka/clinical-trials huggingface dataset:
Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a formidable challenge for the reconstructive surgeon. These defects can be treated with the vascularized iliac crest transfer. The purpose of this study is to assess the reliability and the long-term outcomes of free iliac crest flap transfer for these indications.

Thirteen patients were included in this study. Data was collected retrospectively from the patient records. The study design included three outcome measures to assess the clinical long-term outcomes. These were the Visual Analogue Scale Foot and Ankle (VAS FA), the Oswestry Disability Index (ODI), and the 15-dimensions (15D) health-related quality of life (HRQoL) instrument. The data was collected with postal approach and a written informed consent obtained from the seven participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

Exclusion Criteria:

1) Patients without treatment with the vascularized iliac crest transfer,

Exclusion criteria for the cross-sectional assessment:

1. deceased,
2. below-knee amputation,
3. permanent non-union
Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Study investigators will use EHR data to identify providers of patients whose hypertension treatment was not intensified. Primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). After the intervention, the investigators will conduct virtual interviews with select providers from each arm. A predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.

We propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness.

For Aim 1, we will use Electronic Health Record (EHR) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. We will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control).

For Aim 2, we will conduct interviews with select physicians from each arm. We will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.

Eligibility Criteria:
Provider Inclusion Criteria:

* Primary care physician
* Practicing in primary care at Massachusetts General Hospital
* Caring for at least 2 patients: (1) aged 18-79, (2) for whom the recent BP history in the last 18 months is above goal, (3) whose most recent BP at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. The BP goal will be \<140/90 for all patients. To accommodate changes in care delivery that occurred during the COVID surge, outpatient visits will include in-office and virtual visits that had vitals recorded in the EHR the same day.

Provider Exclusion Criteria:

* fewer than 100 patients on their primary care panel
* practice less than one session per week

Patient Inclusion Criteria:

* had a blood pressure greater than 140/90 mmHg at 2+ PCP visits in the past 12 months
* treatment was not intensified at any of these visits

Patient Exclusion Criteria:

* excluded from the hypertension registry
* currently pregnant or post-partum 6 months
* receiving hospice care
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy

A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.

Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.

Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.

Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic cardiomyopathy (LVEF \<45%) \>6months
* Optimal conventional heart failure medication \>3 months.
* PVB19 viral load \>200 copies/mcg DNA in endomyocardial biopsies (EMBs).
* Signed informed consent
* Aged between 18 and 75 years

Exclusion Criteria:

* Other causes for heart failure
* Significant coronary artery disease (lesions \>70 % stenosis)
* Significant valvular disease
* Untreated hypertension (blood pressure \>140mmHg)
* Substance abuse
* Chemotherapy induced
* Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
* Pregnancy or lactation
* Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
* Known with allergic reactions against human plasma or plasma products
* Having an ongoing progressive terminal disease, including HIV infection
* Having renal insufficiency (plasma creatinin \>115µmol/L or creatinin clearance \<20 ml/min)
* Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
* Having detectable anti-IgA antibodies
* Active SLE
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

The study was planning to randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at the lumbar spine or total hip as measured by DXA during the Screening Period. Screening evaluations were to be completed within 28 days prior to randomisation.

On Day 1, 528 eligible postmenopausal women with osteoporosis were to be randomised in a 2:1:1 ratio to receive MB09-MB09 (Arm 1), Prolia-MB09 (Arm 2), or Prolia-Prolia (Arm 3) using an Interactive Response Sys-tem (IRT).

During the Main Treatment Period, subjects received one subcutaneous injection (60 mg/mL) of study drug on Day 1 and at Month 6. At Month 12, after all efficacy and safety assessments have been performed, the subject were to be enter the Transition/Safety Follow Up Period and were to receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) received MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) received EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) received EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects were to be followed up to Transition Period Month 6.

All subjects received daily supplementation of calcium and vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, diagnosed with osteoporosis.
* Aged ≥ 55 and ≤ 80 years at screening.
* Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening.
* Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by Dual-energy X-ray Absorptiometry (DXA).
* At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint evaluable by DXA.
* Adequate organ function.

Exclusion Criteria:

* Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal antibody.
* History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
* Recent long bone fracture (within 6 months).
* History and/or presence of bone metastases, bone disease or other metabolic disease.
* Intravenous bisphosphonate administered within 5 years of screening.
* Oral bisphosphonates ≥12 months cumulative use prior to screening. If used \<12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled.
* Ongoing use of any osteoporosis treatment or use of prohibited treatment.
* Other bone active drugs.
* History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia.
* Other Inclusion/exclusion criteria may apply.
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure

This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).

Primary endpoints:

* Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded.
* Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.

Eligibility Criteria:
Inclusion Criteria:main Inclusion Criteria

1. Male and female between 18-65 years of age (skeletally mature).
2. Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:

   1. instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
   2. osteophyte formation;
   3. decreased disc height;
   4. ligamentous thickening;
   5. disc degeneration/herniation; or
   6. facet joint degeneration.
3. A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
4. Be non-responsive to non-operative treatment for at least 6 months;

   -

Exclusion Criteria:

1. The Antero-Posterior (AP) diameter (at midline) of the involved level is \<31mm.
2. Any previous spinal surgery at the involved level;
3. Spondylolisthesis \> grade I;
4. Ankylosed segment at the affected level;
5. History or radiographic evidence of osteoporotic fractures in the spine;
6. Paraparesis;
7. Progressive neurologic conditions;

   -
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles

GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
* Embryo transfer performed on day 3

Exclusion Criteria:

* Participation in another trial that was being conducted in our unit at the same time.
* Preimplantation genetic screening cycles.
* Day 5 embryo transfers.
YSPSL for Prevention of Delayed Graft Function Part B

Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and L-selectin. It has been reported that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser degree, E- and L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models to reduce both cytokines and tissue damage associated with ischemia reperfusion and to improve renal function post-transplant. Therefore, the current phase I/II clinical study is designed to assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.

This will be a multicenter, single-dose, dose-escalation study. The study will be in 2 parts: the first, Part A, will be an open label evaluation of single doses of four dose cohorts; the second, Part B will be a randomized, double-blind, placebo-controlled, single-dose study of two dose cohorts. Patients who are undergoing cadaveric kidney transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. A maximum of 24 patients will be enrolled in Part A. 60 patients will be enrolled in Part B.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary cadaver renal transplants

Exclusion Criteria:

* Patient has a planned transplant of a donor kidney from a non-heart beating donor
* Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant) or from donors \< 6 years of age
* Patient has a planned transplant of a kidney from a donor who has received investigational therapies designed to reduce the impact of ischemia/reperfusion (I/R) injury, DGF, or other donor-related immune events
* Patient is planned to receive a living donor kidney; or patient is planned to receive an ABO-incompatible donor kidney
Clearblue Pregnancy Test Lay User Usage Study

The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

The Clearblue HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy. This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged over 18 years representative of the intended user.

A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers. Each volunteer will conduct the pregnancy test using their preferred sampling method (either 'in-stream' or 'dip'). Volunteers will be evaluated against confirmed pregnancy status. Lay user comprehension of the device instructions and usability of the device will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 and over
* Interested in conducting a personal pregnancy test to determine or confirm their pregnancy status
* Willing to reveal their pregnancy status
* Willing to provide a blood sample
* Willing to give informed consent

Exclusion Criteria:

* Significant affiliation with SPD
* Used the investigational pregnancy test previously
* Qualified or trainee healthcare professional (HCP)
* Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices
* Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
* Has a medical condition that means that it is not appropriate to give a blood sample
Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy

Nearly all patients with Duchenne's Muscular Dystrophy (DMD) have scoliosis. Posterior instrumented spinal fusion, which is a surgery to correct scoliosis, has been shown to improve quality of life and satisfaction of both parents and families. The progressive muscular weakness leads to the development of scoliosis soon after the child has become unable to walk. The muscular weakness and scoliosis also affect the pulmonary function of these children. Pulmonary Function Tests (PFT) have been used to determine "pulmonary fitness" prior to surgery as a way to determine how well or if the child will tolerate surgery. Children with poor results on the PFT are determined to be too fragile to tolerate such a large operation. The physicians conducting this study feel that the PFT may be inaccurate and that this may not be the best single test to determine "pulmonary fitness". The physicians conducting the study think things like the time of day the study is done, how tired you are when you complete the test, and how well you understand the test may affect the results of the test.

All patients with DMD have routine PFT's every six months as standard of care. You will be randomized in to one of two groups. The group assignment will be chosen by chance, similar to flipping a coin. If you are assigned to group one you will first have your regularly scheduled PFT in the morning. You will be asked to complete a second PFT that afternoon as least 4 hours after the first PFT. You will then be asked to come back to the clinic in two weeks and repeat these PFT's, once in the morning and once in the afternoon at least 4 hours apart. Each PFT will take approximately 10 to 15 minutes. If you are assigned to group two, you will have your regularly scheduled PFT in the morning and then a second test in the afternoon at least four hours after the first test. After the second PFT you will receive training from a Respiratory Therapist. You will receive teaching handouts to take home and an incentive spirometer and peak flow meter to practice with. You will be asked to practice these tests 2 times a day and record your results. You will then be asked to come back to the clinic in two weeks to repeat 2 PFT's, once in the morning and again at least 4 hours later. All participants will be asked how they feel at the time of testing.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Duchenne's Muscular Dystrophy with diagnosed confirmed by a neurologist
* No longer able to ambulate for any meaningful amount of time
* No previous spinal operation

Exclusion Criteria:

* Any other type of muscular dystrophy or spinal muscular atrophy
* Tracheotomy
* Contractures of the upper extremities that would preclude using arm span as an estimation for height
* Previous spinal surgery
* Asthma, recurrent pneumonia, or other chronic lung disease
Corticosteroids With Vedolizumab in Crohn's Disease

Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

This study will examine prednisone co-induction with vedolizumab in patients with Crohn's disease. To address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. Finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in Crohn's disease through immune phenotyping studies.

Eligibility Criteria:
Inclusion Criteria:

* Age at entry 18 to 70
* CDAI score \> 220
* Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for \> 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (\>2 weeks from last dose) prior to initiation of vedolizumab.
* Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
* Able to provide written informed consent.
* Patient is planned for or eligible to initiate vedolizumab

Exclusion Criteria:

* Concurrent use of anti-TNFα antibodies.
* No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
* No stoma at the time of enrollment
* No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
* Pregnant women or plans for pregnancy within 3 months of study inclusion
* Presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome
* Intestinal stricture requiring surgery
* Abdominal abscess
* Inability or unwillingness to provide informed consent
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
The Effect of a Fasting MimickINg Diet on the Immune System

Fasting or a Fasting Mimicking diet (FMD) can lower blood concentration of glucose and IGF1. Since cancer cells rely mostly on a glucose-based metabolism, FMD renders cancer cells more vulnerable to chemotherapy, thereby enhancing therapeutic efficacy. This process is known as differential stress sensitization (DSS). Another response to nutritional stress by fasting is known as differential stress resistance (DSR). DSR is a state in which healthy cells rather focus resources on protection and internal repair, which can result in reduced chemotherapeutic toxicity. Recent preclinical studies found that fasting or FMD not only aids healthy cell protection, but also has the potential to benefit effector T-cells and could thereby improve antitumor immunity. However in most oncotherapeutic clinical trials investigating the addition of a fasting regimen, other factors such as chemotherapy, surgery and additional medication affect the immune system as well. That is why this explorative study, conducted in healthy subjects, might be more suitable to investigate the immunological alterations upon FMD more specifically. This exploratory study aims to identify immunological alterations by using extensive immunoprofiling before and after three days of FMD in healthy subjects, as well as investigate possible side effects of FMD.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* BMI ≥18.5 and ≤25kg/m2

Exclusion Criteria:

* Chronic disease or active infection
* Medication use other than contraceptive, during the last 12 weeks prior to inclusion.
* A history of allergy
* Blood or plasma donation in the last 12 weeks prior to inclusion.
* Participation in other medical research in the last 12 weeks prior to inclusion.