cyrilzakka/clinical-trials huggingface dataset:
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.

This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
* Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,
* SUI severity should be ≥10 g and \<400 g of urine leakage over 24 hours,
* Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.

Exclusion Criteria:

* Symptoms of only urge urinary incontinence,
* Symptoms of stress urinary incontinence prior to prostate surgery,
* Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
* Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
* Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
* Symptoms of overflow incontinence
* Additional medical restrictions as specified in the Clinical Investigation Plan,
* Additional anatomical restrictions as specified in the Clinical Investigation Plan.
The Patient Cohort of the National Center for Precision Medicine in Leukemia

If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'.

As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment.

The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research.

The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.


Eligibility Criteria:
Inclusion Criteria:

* Patient with newly diagnosed previously untreated de novo, secondary or therapy-related leukemia or related disorders (LRD), including AML, ALL, HR-MDS (according to the international score IPSS), and MNP-related myelofibrosis
* Patient informed and not opposed to participating
* Affiliation to social security or any health insurance

Exclusion Criteria:

* LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)
* Previous treatment for LRD, apart from:

  * Hydroxyurea or previous MDS/MPN-CML therapy in AML patients
  * Steroids, vincristine, intrathecal prophylactic or curative injection or previous CML therapy in ALL patients
  * Erythroid stimulating agents (ESAs), luspatercept, granulocyte colony-stimulating factor (G-CSF), eltrombopag or other TPO agonist, iron chelation therapy, hypomethylating agents (HMAs), lenalidomide or any investigational drug previously used to treat MDS in HR-MDS patients
  * Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAK inhibitors, busulfan, anagrelide, ESAs or any investigational drug previously used to treat MPN in MPN-related myelofibrosis patients
* Patient under guardianship / curatorship
* Patient under AME
* Opposition of the patient to be enrolled in the eTHEMA cohort
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.

A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:

* 150 participants aged 2-5
* 300 participants aged 6-13
* 300 participants aged 14-17
* 900 participants aged 18+

In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.

Participants are expected to be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Self-reported type 1 diabetes
2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months
6. Willing and able to complete registry assessments every two weeks
7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
9. Access to internet via phone, tablet and/or computer to use the registry online platform
10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)
11. Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable

Exclusion Criteria:

1. Diagnosed with sickle cell anemia and/or hemoglobinopathy
2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
3. Adults that are unable to provide informed consent
TAPS2 Transfusion Antenatally in Pregnant Women With SCD

Sickle Cell Disease (SCD) is a serious inherited blood disorder affecting red blood cells. When oxygen levels drop the red cells become abnormally shaped and unable to move through the blood vessels easily. Blood and oxygen do not reach body organs, resulting in episodes of severe pain and other complications. Pregnant women with SCD have an increased risk of both sickle and pregnancy complications, including raised blood pressure. Their babies may grow more slowly in the womb, are more likely to be born early and need special care, and have a higher risk of dying. The only treatments currently available for women with SCD are Hydroxycarbamide (which cannot be used during pregnancy) and blood transfusion. Currently, blood transfusion is only used during pregnancy to treat emergency complications. It has been suggested that giving blood transfusions throughout pregnancy could improve outcomes for both mother and babies. In Serial Prophylactic Exchange Blood Transfusion (SPEBT), sickle blood is mechanically removed and simultaneously replaced with donor red cells. A trial is needed to assess SPEBT given every 6-10 weeks, starting before 18 weeks of pregnancy, compared to standard care. This trial will evaluate outcomes for women (e.g. hospital admission, frequency of crisis) and their infants (e.g. early delivery, birthweight). However, the feasibility of such a study needs to be assessed before embarking on a large multicentre trial. This study is therefore a feasibility study in which we will randomly allocate participants to have either SPEBT or standard care. The study will be carried out in multiple maternity units in England and last two years. The willingness of eligible women to join the study will be assessed, along with how many participants remain part of the study until the end and if participants find the intervention acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with sickle cell disease (all genotypes)
* Gestation 18+0 weeks or below
* Willing and able to give informed consent
* Singleton pregnancy

Exclusion Criteria:

* On long term transfusion programme prior to pregnancy for amelioration of SCD
* Prior Hyperhaemolysis
* Red cell phenotype or antibodies present prevent likely provision of adequate red cell units to support elective EBT programme
* Unable to receive blood transfusion for social, religious or clinical reasons
* Current diagnosis of major medical or psychiatric comorbidity which in the randomising clinicians opinion renders them unable to enter trial
Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (\< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.

The prospective randomized study will be performed in patients after obtaining patient's consent. "Envelop drawing based on random table" will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip disease that is indicated for primary total hip arthroplasty.

Exclusion Criteria:

* A previous THA on the contralateral hip.
* Any condition contraindicated for primary total hip arthroplasty.
* Refuse to be randomized in the study arms.
Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia

The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.

In abdomen surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring abdomen surgery
* Patients of age 18 and over
* BMI \< 40
* Patients who are expected to stay in-hospital overnight after surgery

Exclusion Criteria:

* Patient refusal
* Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
* Known allergy to local anesthetics
* Inability to provide informed consent
* Inability to use a PCA due to languate or comprehension barriers
* BMI \>= 40
* Any patient on opioids for greater than or equal to 3 months duration prior to surgery
* Patients with chronic pain syndromes
Clinical and Economic Outcomes of High Sensitivity Troponin for no ST Elevation Myocardial Infarction in Patients With Chest Pain in Emergency Departments in Italy-An Observational Study

Myocardial infarction is one of the leading causes of death and disability worldwide. In addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and assume a central role for both exclusion ("rule out") and confirmation ("rule in") of acute myocardial infarction , while allowing to reduce the time interval between ER admission and presumptive diagnosis.

Considering the relevance of this topic, we propose to conduct an observational study in real world clinical practice settings at Emergency Departments, aiming to evaluate clinical and economic aspects deriving from the use of the different quantitative assays of high-sensitivity cardiac troponin currently available in patients with suspected acute myocardial infarction and non-ST-elevation ECG (NSTEMI) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.

Observational, prospective, real-world clinical practice, multicentric study, conducted at 12 Emergency Departments in Italy.

Patients with suspected non-ST-elevation myocardial infarction (NSTEMI) who have undergone at least one high-sensitivity cardiac troponin test will be included.

Patients will be enrolled in the study after verification of selection criteria.

Enrollment is consecutive; each Center will suspend enrollment when it has reached the expected number of patients.

An electronic data collection form (eCRF) will be used to automatically generate an enrollment number to identify each patient.

Given the observational nature of the study, high-sensitivity cardiac troponin assays will be used according to current clinical practice.

Patients will be examined in the ED, and on a 30-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chest pain
* Performing at least one cardiac troponin determination test
* Written informed consent

Exclusion Criteria:

* Refusal to provide informed consent
* Elevation of the ST segment to the ECG
* Pregnancy or breastfeeding
* Any other clinical condition not judged by the investigator compatible with participation in the present study.
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B\&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.

Primary outcome: Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation Secondary outcome: Number of infants that reach 21% inspired oxygen during initial study period Secondary outcome: Apnea/bradycardia events in the initial study period Secondary outcome: Mean oxygen requirement following initial study period

Population: Infants born at \<=1250 grams birth weight but \>= 500 grams birth weight

Randomization: Equal allocation stratified by gestational age (\<27 weeks, \>=27 weeks)

Study diagram:

72h 24h X----------\>X1-----------\>Y2 Y----------\>Y1-----------\>X2 Infants will be randomly assigned to treatment X (BabiPlus, control group) or treatment Y (B\&B Bubbler, intervention group). The primary outcome is bubble CPAP failure during the first 72 hours following extubation, measured at time point 1 in the diagram. Bubble CPAP failure is defined as requiring re-intubation or non-invasive positive pressure ventilation (NIPPV), requiring FiO2 of \>60% for one hour or a pCO2 measurement of \>65 mm Hg. For those infants that remain on CPAP during the initial study period, the number that reach 21% inspired oxygen for \>12 consecutive hours will be compared between groups. This difference will also be analyzed using a Chi square test.

Those infants that remain on CPAP following the 72 hour initial study period (e.g., did not meet primary outcome criteria) will be crossed over to the opposite treatment arm for at least 24 hours. The minimum oxygen requirement required to keep the saturations in the ordered range, per standard NICU guidelines, will be recorded and compared between time points 1 and 2.

This study design is complex due to the nature of the disease of these patients. Each day every infant's premature pulmonary disease is evolving. There is no way to control for this.

Eligibility Criteria:
Inclusion Criteria:

1. Infant delivered at \>=500 grams and \<=1250 grams birth weight.
2. Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
3. Infant has received exogenous surfactant during mechanical ventilation.

Exclusion Criteria:

1. Decision by attending physician to redirect to comfort care
2. Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
3. Birth weight \>1250 grams or \<500 grams.
4. Non-English speaking parents. -
Does Immunotherapy Have a Role in the Management of Endometriosis?

Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. "programmed cell death (PD-1)" is expressed on T cells. The immunotherapies in which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as very effective in the treatment of many cancers. If these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.

40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. Pathological specimens will be stained with an immunohistochemical marker named as PDL-1. "programmed cell death (PD-1)" is a protein containing 288 aminoacids and expressed on T cells. It was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. The upregulation of PD-1 is a result of the activation of T cells and it is necessary for the termination of immune response. PD-L1 is a ligand for PD-1. The immunotherapies in which antibodies against these PD-1 and its ligands (especially PDL-1) provides significant improvements in many cancers such as melanoma. Evidence about the role of these ligands in endometriosis will be an important step in its management.

Eligibility Criteria:
Inclusion Criteria:

* patients operated for endometriosis between 2013 and 2014
* pathological examinations proving the diagnosis of endometriosis

Exclusion Criteria:

* patients operated for cysts other than endometriosis
IV Ensure in Patients Receiving OPAT

The purpose of remote therapeutic monitoring is to provide oversight and evaluation of patients receiving IV medications in the home setting post-acute. The goal is to improve patient outcomes and decrease re-admission rates for related diagnoses due to poor adherence. Remote therapeutic monitoring provides data used in the determination of dates, times, and duration of doses administered in the home setting to support real-time intervention by dedicated care managers to support improved adherence with prescribed dosing regiments. The objectives of the study are to:

1. Determine adherence rates for IV medications administered in the home.
2. Assess re-admission against adherence rates.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients enrolled in OPAT (IV antibiotic therapy) discharged to the home setting will be included in the study.

Exclusion Criteria:

* Patients enrolled in OPAT (IV antibiotic therapy) discharged to nursing homes, SNF (Skilled Nursing Facility), and pediatric patients will be excluded from the study.