cyrilzakka/clinical-trials huggingface dataset:
Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)

The multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with rivaroxaban or apixaban.

The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge.

The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at enrollment
* Patients willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are defined (details provided in the study protocol)
* Patients with primary intracranial hemorrhage as confirmed with CT or MRI.
* Patients under effective anticoagulation treatment with rivaroxaban or apixaban at the time of admission, according to the judgement of treating physician and determined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-based anti-fXa measurement.
* Patients treated with andexanet alfa
* Signed informed consent as soon as possible after start of symptoms of initial ICH event, but before discharge

Exclusion Criteria:

* Start of symptoms of initial ICH event \> 24 h before admission to hospital
Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner

Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra contaminating the semen during ejaculation. However, these microorganisms, especially Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species playing an etiologic role in both genital infections and male infertility. Despite there are many consentaneous opinions about its relationship with infertility, its correlation with sperm regular parameters is still controversially. Sperm DNA damage can negatively influence fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate, and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI pregnancy loss rate. Until now, there were fewer clinical researches about the relationship among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the investigators conduct this prospective study to investigate the relationship among them.


Eligibility Criteria:
Inclusion Criteria:

* Male with primary sterility with or without mycoplasma infection

Exclusion Criteria:

1. Combination with chlamydial infection
2. History of using hormone or cytotoxic drugs.
3. Having some other surgical diseases, such as genital tract infection or varicocele
4. Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
5. Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
6. Patients' spouse had some diseases that could not carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.
COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes

This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 in pregnancy or within 6 months post partum
* Planned delivery at Thomas Jefferson University Hospital

Exclusion Criteria:

* Declines routine COVID testing on admission
* In active labor/pain/otherwise unable to provide consent
Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years

As age increases the chances for a woman to become pregnant decrease as well spontaneously as through assisted reproductive technologies (ART). For the treatment of unexplained infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro fertilization (IVF). The aim of the present study is to compare the efficiency in term of delivery rate of IUI and IVF in couples in whom the female age is over 37 years.

IUI can be used to treat infertility when tubes are normal, with no severe endometriosis and enough motile spermatozoa can be inseminated. In these cases IUI are usually performed (4 to 6 attempts) and IVF only in case of IUI failure. Indeed if the pregnancy rate per attempt is higher with IVF, IUI can be performed more frequently (6 times a year vs. 2 for IVF) so that the pregnancy rates after one year of treatment are close. When female age is over 37 years, some ART centers prefer to perform directly IVF, since chances of pregnancy decreases with time. However there is no argument in the literature in favor as well as in disfavor for such an attitude. Indeed the delivery rates after one year treatment with IUI or IVF are not known in this population. Therefore we propose a multicentric randomized controlled trial comparing IUI and IVF in women over 37 with unexplained infertility. Couples will be randomly allocated to IUI or IVF during one year. In case of absence of pregnancy after 4 IUI, couples will be treated by IVF. ART attempts will be performed according to usual procedures of each center. The follow-up will be ended either at the end of the first year of treatment if no pregnancy is obtained or at the time of delivery if a pregnancy is obtained. All data of attempts (demographics data, type and doses of treatment, adverse effects, outcome, number and health state of newborns....) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Female age between 37 and 42 years at the time of inclusion
* Infertility duration ≥ 12 months
* Normal tubes
* No severe endometriosis
* At least 1.5 106 motile spermatozoa to be inseminated
* No previous ART attempt

Exclusion Criteria:

* Tubal abnormalities
* Severe endometriosis
* Less than 1.5 106 motile spermatozoa to be inseminated
* Use of frozen sperm
* Presence of anti-spermatozoa antibodies
Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed osteo or rheumatoid arthritis
* Oral NSAIDs were not deemed appropriate treatment
* Completed diclofenac sensitivity patch test with negative result
* Signed informed consent form

Exclusion Criteria:

* At the discretion of the physician and HPB
Imaging-based Deep Learning for Lung Cancer Diagnosis and Staging

Lung cancer diagnosis and staging are two fundamental and critical issue in clinical lung cancer management and therapeutic decision-making. Invasive procedures for pathologic analysis are gold standard for diagnosis and staging, however, invasive procedures related-complications are inevitable. Noninvasive medical imaging is a powerful tool, however there is almost no room for improvement just according to the experience of radiologist and clinician. The researchers will investigate the role of computer based deep learning of medical imaging in the diagnosis of lesion of lung, lymph node and other sites suspected with metastasis.

Radiologist

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of lung cancer
* PET/CT or CT examination before any cancer-specific treatment

Exclusion Criteria:

* A history of other malignancies
Practice Variation on Antithrombotics in COVID-19

Evidence suggests coronavirus disease 2019 (COVID-19) is associated with an increased incidence of thromboembolic manifestations. Various guidelines on managing antithrombotics in COVID-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis.

The investigators aim to collect the current practices in India among physicians on antithrombotic therapy for hospitalised patients with COVID-19 and after discharge from the hospital.

Immune dysregulation plays a crucial role in the development of severe coronavirus disease 2019 (COVID-19). The autopsy of lungs in deceased COVID-19 patients showed micro thrombosis and inflammatory infiltrates similar to acute respiratory distress syndrome (ARDS). Reports of increased incidence of arterial or venous thrombosis with COVID-19 made initial recommendations regarding using higher doses of anticoagulation. The markers of thrombosis like D-dimer, platelet count, fibrinogen are also increased in patients with COVID-19 along with other inflammatory markers. The pathophysiology of coagulopathy of COVID-19 is still under research. It is likely multi-factorial involving Inflammation, hypoxia, endothelial dysfunction, direct viral cytopathic effect, platelets and complement activation, derangement of the renin-angiotensin-aldosterone pathway.

From the inception of the pandemic, the physicians started using various antithrombotic with higher than prophylactic doses to treat the prothrombotic state. In the absence of clear guidance with conflicting evidence, there is considerable variation in the practices of physicians managing COVID-19.

The investigators are planning for a nationwide multicentre cross-sectional survey on understanding participating physicians practices on the choice of different antithrombotics available in India as of August 2021.

The survey will have three sections: 1. Demographics 2. Antithrombotics in hospitalised patients 3. Antithrombotics after discharge from the hospital

The investigators intend to involve 1000 physicians from different specialities with the help of the steering committee.

Eligibility Criteria:
Inclusion Criteria:

• Physicians involved in the management of adult hospitalised patients with COVID-19 in India

Exclusion Criteria:

* Pediatricians
* Physicians involved in the out-patient management of COVID-19
* Refused to participate
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.

A phase IV, prospective, single arm, multi-center, observational study to collect safety and outcome data of Zepzelca in adult participants with extensive stage SCLC previously exposed to at least one line of treatment with platinum-based chemotherapy. Patients enrolled in the study will be encouraged to complete patient reported outcome (PRO) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
4. Patients initiating Zepzelca treatment in second-line.
5. Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.
6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1

Exclusion Criteria:

1. Patients who discontinued a prior Zepzelca treatment due to adverse events.
2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
3. Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.
4. Known CNS involvement prior to Zepzelca treatment.
5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment
Propofol Pharmacokinetics in Children After Single Bolus Dose

The principle objective of this study is to evaluate pharmacokinetics of propofol after single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of propofol.

PROPOFOL is the most suitable agent currently available for induction and maintenance of anesthesia. So far, the pharmacokinetics of propofol has not been studied in Indian children. We believe that this pharmacokinetic characterization of propofol will help in better management of these patients undergoing surgery under total intravenous anesthesia (TIVA) in our setup. 12 ASA (American Society of Anesthesiologists) grade I patients, 5 to 12 years old planned for elective surgery will be included. Premedication will be done with syrup midazolam 0.5mg/kg. After shifting the patient to the operation table, routine physiological monitoring will be commenced and two intravenous lines will be secured,one in the antecubital vein of one arm and the other vein on the dorsum of the contralateral hand. The antecubital venous access will be used for blood sampling. Anesthetic technique will consist of fentanyl bolus dose of 2ug/kg followed by propofol bolus dose of 2.5 mg/kg. No further propofol will be administered. After loss of consciousness , patients will be paralysed with atracurium (0.5mg/kg) and endotracheal intubation will be performed. Anesthesia will be maintained with isoflurane, oxygen (50%) and nitrous oxide (50%), and intermittent dosages of atracurium. A total of twelve samples will be collected from each patient at 0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240, and 480 min after administration of bolus dose of propofol.The samples will be analyzed using a modified High Performance Liquid Chromatography method described by Pavan et al. The pharmacokinetic parameters will be evaluated using three compartment model to develop a pharmacokinetic model by using the software WINNONLIN (Windows Non Linear Regression Program).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-12 years and ASA (American Society of Anesthesiologists) grade I, planned for elective surgery under general anesthesia

Exclusion Criteria:entered

* Allergic history to one of the constituents of propofol
* Any evidence of cardiovascular, respiratory,metabolic ,renal ,hematologic,hepatic or central nervous system disease
* Previous adverse anesthetic events
* Potential airway management problems
Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may experience acute kidney injury (AKI) after their surgery. Current medical tests cannot identify AKI until approximately 48 hours after it occurs. This study will examine three new biomarkers in blood and urine that may provide a more effective and faster way of predicting AKI in people who undergo CABG or heart valve surgery.

AKI, which is indicated by a sudden change in serum creatinine levels, is a serious complication that can occur after a patient undergoes CABG or heart valve surgery. People who experience AKI after heart surgery may be at increased risk for post-operative complications, including long-term kidney failure or heart damage. AKI is currently identified by testing serum creatinine levels in the blood, which is the traditional marker of kidney function. However, serum creatinine levels can be affected by other non-kidney-related factors and may not positively identify AKI until 48 hours after it begins. This study will examine three new biomarkers found in urine and blood-urine interleukin 18 (IL-18), neutrophil gelatinase-associated lipocalin (NGAL), and cystatin C-that may be able to predict AKI more effectively and faster than serum creatinine levels. In addition, study researchers will also determine if changes in these biomarkers can predict the severity of AKI more successfully than serum creatinine tests.

This study will enroll people undergoing CABG or heart valve surgery at Yale-New Haven Hospital. Before the surgery and once a day for 5 days after the surgery, blood and urine collection will occur. Study researchers will also review participants' medical records. Twelve months after hospital discharge, participants will return to the clinic for a follow-up visit for repeat blood and urine collection and to complete questionnaires. A portion of blood will be saved for future genetic testing; this is optional.

Eligibility Criteria:
Inclusion Criteria for Adults: (must have at least one of the following)

* Emergent surgery
* Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL)
* Ejection fraction less than 35%
* At least 70 years old
* Diabetes mellitus
* Combined CABG and valve surgery
* Repeat CABG or valve surgery

Exclusion Criteria for Adults:

* Pre-operative acute kidney injury
* Enrolled in a conflicting research study
* Prior kidney transplantation
* Baseline serum creatinine level greater than 4.5 mg/dL
* Nephrotoxic drugs administered pre-operatively
* Surgery for only left ventricular assist device

Inclusion Criteria for Children:

* Undergoing open heart surgery

Exclusion Criteria for Children:

* Pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)
Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.

This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine \<2.3 mg/dl, \<20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (\>24 months but \< 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-transplant and are undergoing routine management. In Study A, patients will receive testing eight times: Month 2 (at time of surveillance biopsy) 6(at time of surveillance biopsy), 9, 12(at time of surveillance biopsy), 15, 18, 21 and 24(at time of surveillance biopsy) (plus or minus two weeks). Results of the genomic analysis will be considered in determining patient treatment plans and as a molecular guide to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. In Study B, patients who are at least 2 years post transplant up to 5 years post-transplant will receive testing 8 times: Months 3 ,6, 9, 12, 15, 18, 21 and 24 (plus or minus two weeks)from the time of enrollment into the study. Results of the genomic analysis will be considered in determining patient treatment plans and whether any change is needed, such as whether to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. We expect Study A to be completed 24-30months and Study B to be completed in 24-30 months.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
* Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels).
* Kidney transplant patients who are: \> 60 days post-transplant (Cohort A); \> 2-years post-transplant (Cohort B)

Exclusion Criteria:

* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
* Recipients of previous non-renal solid organ and/or islet cell transplantation.
* Infection with HIV.
* Infection with BK.
* Patients that have nephritic proteinuria (urine protein \>3 gm/day).
Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques

There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria:

* Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl).
* Grade 2 \& 3 of adhesive capsulitis,
* Pain (NPRS) ranging between 3-10
* Reduced normal shoulder ROM's i.e

  * Flexion less than 160 degrees.
  * Extension less than 50 degrees.
  * Abduction less than 170 degrees.
  * External rotation less than 80 degrees.
  * Internal rotation less than 70 degrees

Exclusion Criteria:

* Trauma history of shoulder/surgery.
* Frozen shoulder accompanied with neurological involvement.
* People with any injury or disability of elbow or hand