cyrilzakka/clinical-trials huggingface dataset:
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.

The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.

At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
* Age ≥ 18 and ≤ 65 years.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.
Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers

The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-RSV-f at a low dose, a high dose or placebo.

Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-RSV-f prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.

Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers aged 18 - 49 years, inclusive
2. Able to give written informed consent
3. Healthy (no clinically significant health concerns)
4. Safety laboratory values within the following range criteria normal range
5. Body mass index between 17 and 35 at screening

Exclusion Criteria:

1. Receipt of any investigational RSV vaccine within two years prior to study
2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
3. Administration of any licensed vaccine within 30 days prior to study
4. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination
6. Presence of a fever ≥ 38oC measured orally at baseline
7. Stool sample with occult blood at screening
TVTO Versus TVTFFM for Urinary Stress Incontinence

Women who had urinary stress incontinence and underwent one of two procedures: the classic TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.

We will enroll women that underwent one of the two surgeries: TVTO or the modification where the needle passes somewhat to the side to prevent the post operative pain, for urinary stress incontinence. Data will be collected from the charts. Telephone interviews will be carried out. Physical examination will also be incorporated.

Eligibility Criteria:
Inclusion Criteria:

* Women with Urinary Stress Incontinence treated by TVT

Exclusion Criteria:

* Women without with Urinary Stress Incontinence or not treated by TVT
Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for HCC patients in hepatitis B endemic area.

The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients for each arms will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
* HCC patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
* without evidence of extrahepatic metastasis
* All target tumors must be encompassable within single irradiation field (15x15 cm maximum)
* no previous treatment to target tumors by other forms of RT
* liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
* Age of ≥18 years
* performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
* WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites)
* no serious comorbidities other than liver cirrhosis
* written informed consent

Exclusion Criteria:

* evidence of extrahepatic metastasis
* age \< 18 years
* liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7)
* previous history of other forms of RT adjacent to target tumors
* poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* multicentric HCCs, except for those with the following two conditions: \*multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) \*lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients at a Dose of 4E13 vg/kg

This Phase III clinical study will assess the efficacy of BMN 270 defined as FVIII activity, during weeks 49-52 following intravenous infusion of BMN 270 and assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy and the number of bleeding episodes from week 5 to week 52.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as evidenced by medical history.
2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry.
3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days.
4. No previous documented history of a detectable FVIII inhibitor of less than 0.6 Bethesda Units (BU).

Exclusion Criteria:

1. Detectable pre-existing antibodies to the AAV5 capsid.
2. Any evidence of active infection or any immunosuppressive disorder, including HIV infection.
3. Significant liver dysfunction, prior liver biopsy showing significant fibrosis, liver cirrhosis of any etiology or history of hepatic malignancy.
4. Evidence of any bleeding disorder not related to hemophilia A.
5. Active Hepatitis C.
6. Prior treatment with any vector/gene transfer agent.
Analyses of Existing Framingham Data

Since 1948, the Framingham Study has examined a group of men and women every two years for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. In 1971 the Framingham Study began a study of the offspring of the original group, including data collection on blood pressure, cigarette smoking, weight, and other factors that are of interest to studies of eye disease. Researchers gave eye exams to some of the original group and to the offspring group. Data from these eye exams have been used to examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma.

The purpose of this study is to use the previously collected data for continued research on eye-related disorders. No new eye examinations will be conducted.

...

We propose to continue to analyze existing Framingham Eye and Heart Study data to identify possible risk factors for various eye diseases. Originally begun in 1948 by the National Heart, Lung and Blood Institute (NHLBI), the Framingham Heart Study has been examining a population-based cohort of men and women biennially since 1948 for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. In 1971 the Heart Study began a prospective study of the offspring of the original cohort. The Heart Study has collected data on blood pressure, cigarette smoking, weight and many other factors of interest for epidemiologic studies of eye disease. Eye examinations were conducted on the survivors of the original cohort in a collaborative effort between the NEI and the NHLBI between 1973 and 1975 (Framingham Eye Study I; FES I) and then again between 1986 and 1989 (Framingham Eye Study II; FES II). Eye examinations were conducted on the Offspring Cohort from 1989 to 1991 (Framingham Offspring Eye Study; FOES). The Framingham data are unique in allowing epidemiologic studies with both cross sectional and longitudinal designs. Over the years, data from the Heart Study and the various eye studies have been used to examine demographic and risk factor characteristics for cataract, diabetic retinopathy, myopia, and glaucoma. To date this collaborative effort has yielded 31 publications by the National Eye Institute's Division of Epidemiology and Clinical Research; Rita Hiller is an author of 11. This proposal is for the continued use of the previously collected Framingham data. All studies will be done in collaboration with Heart Study investigators from Boston University which manages the study and conducts annual IRB reviews. No new eye examinations will be done.

Eligibility Criteria:
* This study is of existing ocular data from the Framingham Eye Study. Since the participants have already been recruited, there are no further exclusions from the study.
China Acute Myocardial Infarction Registry

This study is to build a Chinese national registry and surveillance system for acute myocardial infarction(AMI) to obtain real-world information about current status of characteristics, risk factors, diagnosis, treatment and outcomes of Chinese AMI patients; And to propose scientific precaution strategies aimed to prevent effectively from the incidence of AMI; And to optimize the management and outcomes of AMI patients through implementation of guideline recommendations in clinical practice, and analysis and development of effective treatment strategies; And to create cost-effective assessment system.

The aim of the study is to establish the national platform for surveillance, clinical research and translational medicine in China, designed to facilitate efforts to improve the quality of AMI patient care and thus decrease morbidity and mortality associated with AMI.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must be admitted within 7 days of acute ischemic symptoms and diagnosed acute ST-elevation or non ST-elevation myocardial infarction. Diagnosis criteria must meet Universal Definition for AMI (2012). All participating hospitals are required to enroll consecutive patients with AMI.

Exclusion Criteria:

* Myocardial infarction related to percutaneous coronary intervention and coronary artery bypass grafting.
A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease

Investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from Mircera to daprodustat.

Investigator-initiated, multicenter, prospective, interventional study to determine the clinical and operational effectiveness of transitioning from intravenous or subcutaneous Mircera to oral daily daprodustat as assessed by change in hemoglobin. This trial will be conducted at up to 40 United States Renal Care sites in the United States and will enroll approximately 200 patients (\~150 in-center hemodialysis and \~50 home dialysis patients).

Participants who are prescribed daprodustat by their treating physician and have taken at least a single dose of daprodustat will be considered enrolled into the clinical trial. After the prescription of daprodustat by the treating physician, each subject will be followed prospectively for a treatment period of approximately 120 days.

Subjects taking daprodustat will not have any in-person study related visits and will follow their usual schedule with regard to standard of care. Standard of care laboratory assessments as ordered by the primary nephrologist will be utilized. Twice monthly hemoglobin collection and monitoring will be required as part of the standard of care laboratory assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥18 years old.
2. Diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for ≥ 4 months.
3. Has received at least a single dose of Mircera within 45 days prior to prescription of Daprodustat by treating physician.
4. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

1. A known allergy or intolerance to daprodustat or any of its constituents.
2. Uncontrolled hypertension.
3. Active malignancy as documented in electronic medical record.
4. Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
5. Severe hepatic impairment as documented in the electronic medical record.
Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis

Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world population is infected with Mycobacterium tuberculosis. There is an increase in the number of cases of classic tuberculosis in developing countries, even if number of cases are declining in developed countries. However, in developed countries this decrease is counterbalanced by the emergence of multidrug resistant (MDR) strains of the bacteria.

There are also latent forms (1/3 of the world population) of the infection that can be reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and 9 million new cases are identified, including about 500,000 cases of MDR TB.

The spread of this disease as well as the increasing number of cases of MDR tuberculosis, reinforce the need for research and development of strategies of diagnosis and management of this affection.

Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at least three weeks to be performed. The objective of this study is to evaluate the sensitivity and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice, in order to administrate an efficient treatment as soon as possible.


Eligibility Criteria:
Inclusion Criteria:

* Positive TB patients
* Patients who performed biopsy before inclusion

Exclusion Criteria:

* Anti-tuberculosis drugs administered before biopsy
* Patients who refuse to participate
The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft

In clinical settings, split-thickness skin graft (STSG) remain the gold standard for covering large skin defects. However, STSGs usually bring complications to the donor sites. The study objective was to compare the efficacy of thick split-thickness skin graft versus thin split-thickness skin graft in the reconstruction of the donor site.

All patients were randomly divided into two groups. For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique). For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients. The 36-item short form health survey (SF-36) scores, pain scores, pruritus scores, scar scores and rates of complications were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had skin defects at functional sites or joint sites.
2. Patients aged 20-80 years.
3. The lateral thighs were chosen as the donor sites.

Exclusion Criteria:

1. Patients who were unable to complete the follow-up.
2. Pregnant or nursing mothers were not included.
3. Patients had an alternative source of pain other than surgical sites.
4. Patients with organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or cancers.
5. Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
6. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
7. Other reasons.
Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

The main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. A second aim is to assess the direct contribution of cortical lesions - independent of WM injury - on the diffuse grey matter damage.

Thirty MS patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal MRI study at 7T to assess cortical MS injury. Clinical (EDSS) and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. MRI protocol is designed to increase the detection rate of CL using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. Thus, MRI acquisition will include MP2RAGE, T2\*, FLAIR and DIR as previously published but also recent MRI technique like FLAWS, focusing on the grey matter by attenuating the white matter and CSF signal. Finally, QSM sequences will be performed. QSM measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. Due to physical properties of the technique (bipolarity), we suppose that high resolution QSM will be more sensitive that previous used sequences to depict cortical lesions. Using this multi-contrast approach with relevant MRI sequence and with a high resolution whole brain exploration might improve the detection of CL in early MS.

Furthermore, MRI protocol allow us to estimate neuronal loss (T1 relaxation time), myelin and iron content (QSM and T2\* relaxation time) within and outside cortical lesions in GM.

The present study is an opportunity to assess cortical pathology in MS from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing-remitting MS (McDonald's criteria 2010) early (duration evolution \<2 years),
* Age between 18 and 45 years,
* No history of neurological symptoms suggestive of demyelinating pathology,
* No corticosteroids in the month preceding the completion of the MRI,
* Realization of the MRI in the first 6 months following the inaugural clinical episod

Exclusion Criteria:

* Argument for a differential diagnosis (systemic lupus erythematosus, antiphospholipid syndrome, Behçet's disease, sarcoidosis, Lyme disease, cerebral arteritis, lymphoma CNS, etc.),
* History of neurological or psychiatric illness,
* History of taking immunosuppressive drugs,
* Claustrophobia
* Pregnancy,
* Patient unable or unwilling to give consent, patient under guardianship,
* Patient not affiliated to a social security regime
The Northstar Trial

The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.

The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.

Exclusion Criteria:

* Lack of legal capacity.
* Insufficient proficiency in the Dutch language.
Supernormal Goal for Proximal Femur Fracture

This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.

Augmentation of oxygen delivery using fluids with or without inotropes has been shown to improve surgical outcome in high-risk patients. Patients with proximal femoral fracture are considered high risk. However, most of this cohort elderly patients have poor cardiovascular condition and may not achieve the oxygen delivery goal. We will perform an observational pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients with proximal femoral fracture.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 70 yr
* Weight over 35 kg
* Underwent proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

Exclusion Criteria:

* Patients who could be harmed due to the treatment (ongoing myocardial infarction, chronic dialysis)
* Monoamine oxidase inhibitor use within the last 14 days
* Pathological fractures and conditions
* Inability to give informed consent(as judged by a research team member)
* Anticipated difficulties obtaining data during the first postoperative year (as judged by a research team member)