cyrilzakka/clinical-trials huggingface dataset:
Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies with Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device

This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.

The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.

Eligibility Criteria:
Inclusion Criteria:

Patient:

1. Age. Patient age \< 23 years. Both genders and all races eligible.
2. Disease eligibility

Leukemias/lymphomas:

* Acute myeloid leukemia, primary or secondary
* Disease status: remission or \<10% bone marrow blasts
* Myelodysplasia
* Acute lymphoblastic leukemia
* Disease status: in hematologic remission
* Chronic myelogenous leukemia:
* Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
* Mixed lineage or biphenotypic acute leukemia
* Lymphoblastic lymphoma
* Disease status: remission
* Burkitt's lymphoma/leukemia:
* Disease status: in remission

Exclusion Criteria:

* Patient

  1. Patients who do not meet disease, organ or infectious criteria.
  2. No suitable donor
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial

According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.

The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Able to provide spoken and written informed consent for the trial;
* Histopathological confirmed neuroendocrine tumor;
* Fulfill the clinical criteria for PRRT;
* At least one soft tissue lesion \> 2 cm;
* Aimed administered activity of 7400 MBq;
* ECOG score (performance status) 0-2.

Exclusion Criteria:

* Not possible to discontinue LA-SSA for 4-6 weeks;
* Use of short-acting SSAs;
* Pregnancy and lactating female patients;
* Inability to comply to the study procedures;
* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.

The aim of this study is to determine whether antibiotic treatment directed against Aspergillus Fumigatus will be effective at preventing respiratory exacerbations and improving pulmonary function in patients with cystic fibrosis(CF) who are chronically colonized/infected with aspergillus. This aim will be accompanied by means of a randomized, double-blind, placebo-controlled clinical trial incorporating two parallel treatment arms.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Patient must be known to be chronically colonized with Aspergillus fumigatus.
* Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
* 6 years of age and older
* Patients must weigh at least 20 kg
* Post-menarche females must be using an effective form of contraception.

Exclusion Criteria

* Inability to give informed consent.
* Respiratory culture positive for B.cepacia complex
* Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
* Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization
* Neutropenia, absolute neutrophil count\&lt; or = 1000 within a 3-day period prior to randomization
* History of biliary cirrhosis documented by liver biopsy or imaging.
* History of portal hypertension.
* Investigational drug use within 30 days of randomization date.
* History of alcohol, illicit drug or medication abuse within 1 year of randomization.
* Women who are pregnant, breastfeeding or trying to conceive
Transthoracic Ultrasonography Findings and Their Relation to Spirometric Indices in Patients With Obstructive and Restrictive Respiratory Diseases

Evaluation of respiratory function is considered a crucial component in the assessment of patients with a wide range of respiratory diseases. Spirometry is considered a common method of measuring pulmonary function. Recently, Transthoracic ultrasound yields important diagnostic information within minutes. Respiratory muscle ultrasound is used to evaluate the anatomy and function of the respiratory system.


Eligibility Criteria:
Inclusion Criteria:

1 -age \>18 years 2-patients diagnosed with COPD or asthma. 3-patients diagnosed with ILD or any other restrictive lung diseases. 4-normal people.

Exclusion Criteria:

1. age \<18 years old.
2. critically ill patients in intensive care units.
3. patients with neurological diseases.
Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

This study will evaluate the medication adherence, clinical efficacy, and safety of EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled study. The primary outcome is change in medication adherence from baseline to the end of the study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.

The main aim of this study is to assess the immunosuppressant adherence, efficacy, and safety in post liver transplant patients converted from twice daily tacro to once daily EnvarsusXR. Tacrolimus trough level, clinical markers of liver disease, HbA1c , eGFR will be assessed at baseline, 1 week, 2 week, 4 week, 3 month and 6 months. Graft rejection will be assessed using routine standard guidelines to identify the cause. All patients post 1 year liver transplant, and within 5 years will be eligible to participate.

The primary hypothesis is that once daily dosing will improve medication adherence in patients randomized to the test arm as compared to the control arm, over a period of 9 months. The clinical efficacy will be assessed by no difference in standard deviation of tacrolimus in the two groups. The secondary hypothesis is that improved medication adherence will lead to improved patient reported quality of life (as assessed by PROMIS-29), and better health outcomes (as assessed by HbA1c, eGFR).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 1 year post liver transplant, but within 5 years of transplant
* Serum Creatinine\<= 2.5 mg/dl; AST,ALT, AP and GGT\<=2 times ULN
* Patient must be on a stable tacrolimus dose, with tacrolimus trough levels between 5-12 ng/ml for 4 or more weeks before enrolment

Exclusion Criteria:

* Cognitive impairment which precludes participation
* Projected survival, in the opinion of the provider, of less than three months
* Any other solid organ transplant (kidney or pancreas)
* Use of any drug which is known to interfere with tacrolimus metabolism
Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies, additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.

Patients are recruited for 3 day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation to determine if maternal blood glucose excursions correlate with deviation from optimized birth weight.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant patients under 28 weeks gestation

Exclusion Criteria:

- Pre-gestational diabetes
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions

This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.

The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Female, 19 years ≤ age ≥ 80 years
2. Those who be expected to do operation about non palpable breast lesion excision
3. Those who have lesion vial mammography and breast ultrasound
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients who be expected to do mastectomy
2. Patients with multiple tumor or diffuse microcalcification
3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection
4. Patients who were treated with moderate to severe radiotherapy
5. Patients who were treated with neoadjuvant Chemotherapy
6. Patients with active invading skin connective tissue disease
7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer
8. Patients who have an allergy to investigational product or any of the component with the Investigational product
9. Patients who disagree about contraception for this clinical trial
10. A pregnant women or lactating women
11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent
12. Patients who investigators determines unsuitable for this clinical trial
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.

This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
* Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
* Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).

Exclusion Criteria:

* Positive DRE;
* PSA \> 10 ng/ml or unstable PSA (doubling time \<3 years) during the last year prior to enrolling in this study;
* PSAD \> 0.15 (calculated using most recent PSA divided by MRI prostate volume);
* First degree relative diagnosed with prostate cancer
* First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
* Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.
Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and lymphocyte subtypes with Flow-cytometry.

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease. There are limited number of studies in the literature about the immune parameters in the evaluation of acute pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T lymphocyte and Treg population were evaluated.Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. In patients diagnosed with acute biliary pancreatitis, determination of the course of the disease at the time of diagnosis is extremely important for treatment and survival.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis with lymphocyte subtypes via Flow-cytometry.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Diagnosis of acute biliary pancreatitis
* Sign the voluntary consent form

Exclusion Criteria:

* Being under 18 or older than 80
* Not signing the voluntary consent form
* Pancreatitis resulting from an interventional procedure (ERCP, surgery, etc.)
* Pregnant women
* Being a history of immunodeficiency
* Cancer history
Development of Tools for Respiration and Circulation Exploration

This study is aimed to develop analysis methods and measurements tools for physiological variables : respiration, circulation and their mutual interactions and with the functions involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...). The devices that are used are non invasive. The development of these tools needs to be validated on physiological signals obtained in healthy volunteers.

The analysis and interpretation of a record consist, for example, to measure the amplitude of the respiratory modulation of the cardiac period, a witness of the level of the subject's sympathetic activity.

To do this, a mathematical model of this oscillation is adjusted on the experimental data, and its characteristics (amplitude, phase, non-linearity...) are considered indexes of the interaction to be compared with the same characteristics in other conditions.

The transition to clinical applications requires validation of the developed tools on physiological signals recorded on healthy volunteers in a non-clinical environment, avoiding extra psychological stress in the Protocol followed.

Whether it is for the development of tools or their validation, it is essential that the sensors used are non-invasive.

Recorded situations are those of everyday life, such as working (only sedentary work are envisaged), eat, talk, rest and move from one place of life to another one.

Eligibility Criteria:
Inclusion Criteria:

* healthy, major and socially insured human subjects

Exclusion Criteria:

* deprived of liberty, hospitalized and protected human subjects
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

Eligibility Criteria:
Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

1. Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
2. Was capable of understanding and complying with protocol requirements.
3. Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

1. With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
2. With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
3. With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.
Symbicort in Chronic Obstructive Pulmonary Disease

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

* limitations; possible risks; warnings; contraindications mentioned in the SPC.
Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip

Several risk factors for the development of osteonecrosis of the femoral head following treatment of developmental dislocated hip have been reported. The need for further research with a large-enough sample size including statistical adjustment of confounders was demanded. The purpose of the present study was to find reliable predictors of osteonecrosis in patients managed for developmental dislocation of the hip and to evaluate if delayed treatment increased the risk of residual acetabular dysplasia requiring secondary surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Follow-up \> 3 years

Exclusion Criteria:

* teratological hip dislocation
* neuromuscular disease
* previous open reduction at another medical institution
Evaluation of the Repeatability and Reproducibility of AngioVue

The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.


Eligibility Criteria:
Inclusion Criteria:

1. Normal

   * Age \> 18.
   * No retinal pathology or glaucoma.
2. Glaucoma patient

   * Age \> 18.
   * Have glaucoma.
3. Retina patient

   * Age \> 18.
   * Have retina pathology.

Exclusion Criteria:

1. Normal

   * Unable to complete required exams.
   * Poor quality image data.
2. Glaucoma patient

   * Unable to complete required exams.
   * Poor quality image data.
   * Retinal pathology.
3. Retina patient

   * Unable to complete required exams.
   * Poor quality image data.
   * Glaucoma.