cyrilzakka/clinical-trials huggingface dataset:
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease.

Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities.

Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting.

Patients with TASC D lesions will be treated with open bypass surgery after angiography.

The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.


Eligibility Criteria:
Inclusion Criteria:

Clinical Inclusion:

1. Must be at least 18 years of age.
2. Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.
3. Symptomatic patient as evidence by IC or CLI.
4. Patient has failed maximized medical treatment and exercise program.
5. Patient has a resting ABI \< 0.9 or an abnormal exercise ABI if resting ABI is normal.Patient with non-compressible arteries (ABI \> 1.2) must have a TBI \< 0.8.
6. Patient has a de novo or restenotic lesion(s) with \> 50% stenosis documented angiographically.
7. Patient agrees to return for all required clinical contacts following study enrollment.
8. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Anatomical Inclusion:

1. Patient with any SFA lesion
2. At least one tibial vessel runoff with \< 50% stenosis
3. Lesion starts start at least 1 cm distal to the deep femoral artery
4. Lesion end at least 3 cm above the knee joint
5. Target vessel reference diameter is \> 3 mm \& \< 6.5 mm

Exclusion Criteria:

Clinical exclusion:

1. Known allergic reaction to anesthesia not able to overcome by medication.
2. Known allergic reaction to contrast not able to overcome by medication.
3. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine.
4. Bleeding disorder or refuses blood transfusion.
5. Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)
6. Unstable angina, recent MI within a month
7. Malignancy or other condition limiting life expectancy to \< 5 years.
8. Renal insufficiency (serum Cr \> 2.0)
9. Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity).

Anatomic Exclusion:

1. Lesion \< 1 cm from origin of DFA
2. Lesion \< 3 cm from the knee joint
3. Chronic total occlusion of SFA \> 20cm.
4. Chronic total occlusion of CFA.
5. Proximal trifurcation occlusions.
Exercise Intervention After Lung Cancer Surgery

A combination of supervised and un-supervised exercise in patients after lung cancer surgery is evaluated with regards to aerobic capacity, strength, physical activity and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Elective lung cancer surgery
* Ability to perform tests
* Able to communicate in Swedish
* Willing to participate in supervised exercise

Exclusion Criteria:

-
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

Low carbohydrate diet may influence the plasma lipid levels.

Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication
AryoTrust® (Trastuzumab) Safety Study

This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant chemotherapy regimens.

The present study is an observational, multicenter, non-interventional, single-arm, open-label PMS study conducted in Iran. No control groups are included in the study design.

The objective of this PMS study is to monitor and assess the safety of AryoTrust in patients with non-metastatic HER2-positive breast cancer in adjuvant setting over a period of 27 weeks.

Treatment with AryoTrust in this study is defined as the administration of 6mg/kg AryoTrust, every 3 weeks during the 27 weeks of the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens

Exclusion Criteria:

* Patients who had received Trastuzumab as part of their therapy or were not candidates for treatment continuation after adjuvant chemotherapy
Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy

Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.


Eligibility Criteria:
Inclusion Criteria:

* Histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) suitable for curative-intent radiotherapy
* Patients suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
* Life expectancy \> 4 months
* Age ≥ 18 years
* Patient has read and understood the participant information sheet and given informed consent

Exclusion criteria:

* No histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) and not suitable for curative-intent radiotherapy
* Patients not suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
* Life expectancy \< 4 months
* Age \< 18 years
* Patient has not read and understood the participant information sheet and has not given informed consent
An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
* At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (\> 1.0 cm) extranodal lesion
* Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
* Adequate hematologic and organ function

Exclusion Criteria:

* Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
* Currently eligible for autologous SCT
* Current or past history of CNS lymphoma or leptomeningeal infiltration
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Contraindication to atezolizumab (if applicable) or tocilizumab
* Clinically significant toxicities from prior treatment have not resolved to Grade \</= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
* Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
* Evidence of any significant, concomitant disease as defined by the protocol
* Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
* Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* History of autoimmune disease with exceptions as defined in the protocol
the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn

Ocular chemical burn is one of the cause of vision loss in our country, and there are no satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.

Corneal burn is a ocular damage disease included chemically burned and thermally burned. Surgery of corneal transplantation，amniotic membrane transplantation are some of effective,however,these therapy are expensive and the transplantation resources are limited. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids also is important, however, long time usage of corticosteroids often cause severe side-effects. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self -renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. Many animal research also revealed that MSC have effect on the ocular alkali burned. And subconjunctivity injection is efficient, the clinical study of MSC on treating other disease have been developed rapidly recently, in further ,the outcome are encouraging, and no side-effect related MSC was reported, MSC can come from bone marrow, Umbilical cord blood，Adipose tissue and so on, but bone marrow MSC is mostly common used. The investigators propose to assess the efficacy and safety of human bone marrow mesenchymal stem cell in the treatment of corneal burn in human.

Eligibility Criteria:
Inclusion Criteria:

1. must be ocular burns including chemically burned or the thermally burned
2. the severity degree should above the Ⅳ degree,including the Ⅳ degree(according the classification of Dua standard,2001)
3. the subjects are willing to accept this research,and promise to coordinate with the researchers during the follow up period
4. the subjects should abide by the laws and rules of the study.
5. the incident time should be within 2 weeks -

Exclusion Criteria:

1. the visual acuity is blind in any of the eye
2. have corneal perforation or have the corneal perforation tendency
3. have been accepted surgury on eyeball after trauma
4. IOP≥25mmHg even after antiglaucoma
5. have the history of other corneal diseaze or surgury
6. have the history of radiotherapy or surgury in the eyeball
7. associated with corneal ulcer or endoophthalmitis
8. uncontrolled hypertension(≥150/95mmHg)
9. abnormal liver and renal function
10. the pregancy women -
Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation

The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation
* Signed inform consent

Key Exclusion Criteria:

* Paroxysmal atrial fibrillation
* Contraindications for surgical ablation
* Unwilling to participate
Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

In this clinical trial the Investigators aimed to assess the Adrenomedullin (AM) release in urine and plasma in preterm infants undergoing Sustained Inflation or Positive Pressure Ventilation at birth to manage respiratory failure.

Background and objectives: The respiratory management in the DR may play an important role in the development and prevention of lung injury. The sustained lung inflation (SI) is a promising approach to facilitate cardio-respiratory transition, but currently, although it has been shown to decrease the duration of MV, seems not to guarantee relevant benefits compared to Positive Pressure Ventilation (PPV). In order to clarify the impact of these two different approaches on lung tissues, this study measures Adrenomedullin (AM), which is a biomarker involved in lung development.

Methods: we conducted a prospective case control-study in a cohort of very low birth weight (VLBW) infants (\< 1500 g) of 28+0-30+6 weeks of gestational age (GA), who received SI or PPV during stabilization in DR.

Exclusion criteria were major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations), fetal hydrops, lack of parental consent and need for endotracheal intubation at birth.

Blood samples for AM measurement were collected at birth from the arterial umbilical cord before resuscitation maneuvers, then at 1 hour from birth and at 24 hours from birth. Moreover, urine samples were collected, in correspondence with the first urine emission while in NICU and at 24 hours of life.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 28+0 and 30+6
* need for respiratory support in the delivery room

Exclusion Criteria:

* major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations)
* fetal hydrops
* lack of parental consent.
* Need for endotracheal intubation at birth
ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
* Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
* Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

Key Exclusion Criteria:

* Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
* Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
* Reports moderately severe to severe symptoms of depression
* Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
* Recent suicidal ideation or behavior
* Current or recent moderate to severe substance use disorder as assessed by the MINI
* Clinically significant abnormal findings in safety assessments
* Has significant progressive disorders or unstable medical conditions
* Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
* Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
* Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Effects of Nordic Walking on Prenatal Health

This randomized controlled trial (RCT) aimed to evaluate the effects of Nordic walking (NW) on gait kinematics, musculoskeletal pain, and quality of life in pregnant women.

Healthy pregnant women (N=50), aged 20-40 years and between 13 and 28 weeks of gestation, experiencing mild to moderate musculoskeletal pain, will be recruited. Participants will be randomized into either an intervention group (NW training) or a control group receiving standard prenatal care. The intervention group will undergo a 4-week learning phase followed by an 8-week NW program (3 sessions per week, 45 minutes per session), led by a certified instructor. Outcome measures will be assessed at baseline, after 4 weeks, and post-intervention (8 weeks), including spatiotemporal gait parameters (will be assessed using the GAITRite system), musculoskeletal pain (will be measured via Visual Analog Scale, VAS), and quality of life (will be measured using the SF-36 Health Survey).

Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 20 to 40 between 13 and 28 weeks into singleton pregnancy.
* Participants must be experiencing mild to moderate musculoskeletal discomfort, such as lower back or pelvic pain,
* Participants have no prior musculoskeletal or neurological diseases.
* They must have no contraindications to exercising throughout pregnancy, as established by obstetrician clearance, and be able to engage in moderate physical activity under medical recommendations

Exclusion Criteria:

* History of diseases affecting bony structures or lumbar intervertebral discs.
* Pain caused by non-musculoskeletal factors (such as urinary tract infections or obstetric complications).
* Multiple pregnancies, pre-existing mobility conditions, and high-risk pregnancies or complications that restrict physical activity.
A Study of JNJ-64281802 for the Prevention of Dengue Infection

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents
* Must have a body mass index (BMI, weight in kilogram \[kg\] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive, and a body weight of greater than or equal to (\>=) 40.0 kg at screening
* A woman must have a negative highly sensitive urine pregnancy test at screening
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for \>= 90 days after receiving the last dose of study intervention
* Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* Having any dengue virus (DENV)-associated clinical signs and symptoms
* Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
* Any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Reduced immune function to be: (a) Known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy)
* Received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 \[COVID-19\] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study
Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.

In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .

A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergone pancreatoduodenectomy
* No preoperative radiological suspicion of lymph node metastases.

Exclusion Criteria:

- Age \< 18