cyrilzakka/clinical-trials huggingface dataset:
A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults

The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.


Eligibility Criteria:
Inclusion Criteria:

* Declared healthy by the investigator on the basis of physical examination, medical history, vital signs and clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Heterosexual male participants must not engage in intercourse with a female partner of childbearing potential who is not using a highly effective contraceptive method
* All female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and immediately prior to study vaccine administration
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Agrees not to donate blood until the Week 4 visit

Exclusion Criteria:

* Clinically significant neuro-psychiatric, cardiovascular, pulmonary, liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min) using the Cockcroft-Gault Equation); metabolic, gastrointestinal, urologic, or endocrine disease that is - in the opinion of the investigator - uncontrolled
* Any history of malignancy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Previous severe allergic reaction after vaccination with polio vaccine
* Known allergies, hypersensitivity, or intolerance to one of the excipients of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) or conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV)
* Received any polio vaccine within 6 months before study inclusion
The Women In Steady Exercise Research (WISER) Survivor Trial

WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer survivor
* overweight or obese (BMI of 25 or greater)
* must have breast cancer related lymphedema
* at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
* the eligible age range will have no lower limit.
* currently free of cancer

Exclusion Criteria:

* medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
* inability to walk for 6 minutes unaided
* extremely obese (body mass index greater or equal to 50 kg/m2)
* plans for additional (e.g. curative or reconstructive) surgery during the study period
* self-report of weight-lifting within the past year
* already engaging in 3 or more times weekly aerobic activity of moderate intensity
* planning to move away from the area over the next year
* current use of weight loss medication (OTC or prescription)
* self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
* weight loss of greater than 10 % in the past 3 months
* history of bariatric surgery
* women who are pregnant
Ventricular Wall Motion Characterization

The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.


Eligibility Criteria:
Inclusion Criteria:

* Be in sinus rhythm
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations
* Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy

Exclusion Criteria:

* Have permanent AF
* Exhibit Cheyne-Stokes respiration
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Be less than 18 years of age
* Be pregnant
* Be currently participating in any other clinical investigation
Virtual Reality Immersive Method for Spider (Phobia) Exposure Therapy (VIMSE)

The aim of this study is to examine the efficacy of virtual reality exposure therapy as a treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a non-inferiority margin of a 2-point difference between groups.


Eligibility Criteria:
Inclusion Criteria:

* Score of 10 or less in Behavioral Approach Test
* Individual meeting DSM-5 criteria according to interview for primary diagnosis of specific phobia, spider
* Swedish residency
* Fluent in Swedish

Exclusion Criteria:

* Ongoing psychotherapy
* Ongoing psychotropic medication (unless stabilized for three months)
* Indication of suicidal ideation, as assessed by item 9 of the PHQ-9
* Meets criteria for alcohol or substance use disorder
* Meets criteria for serious mental disorder, such as bipolar disorder, schizophrenia or psychosis
* Balance and/or eyesight problems (such as lack of stereoscopic vision) that could interfere with VR treatment
Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS

Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. The purpose of this multicentric observational prospective study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS (survivors vs. non survivors) and to confirm their association with 28-day mortality.

Background: The acute respiratory distress syndrome (ARDS) remains common (15% of ventilated patients in the ICU), severe (30% of mortality) and have no specific treatment. Impaired epithelial repair with fibroproliferation is observed in non resolutive form of ARDS. Fibrocytes are cells that both express markers of hematopoietic cells (CD34+, CD45+) and fibroblasts (collagen-1). Fibrocytes may be recruited directly from the pool of circulating blood monocytes but also derive from monocytes in situ in absence of serum amyloid P (SAP or pentraxin-2). In murine models of lung injury, it has been shown that fibrocytes were recruited in the lung and contribute to the local fibrogenesis. Our team is the first to have demonstrated during ARDS in human the presence of fibrocytes among the alveolar cells obtained by bronchoalveolar lavage (BAL) (Quesnel et al, Eur Resp J, 2010). In a second single-center work enrolling 122 patients, we have shown that a percentage of alveolar fibrocytes \> 6% was associated with an increased risk of death (HR = 6.2 \[2.8 to 13.6\], p \<0.0001). However, this result remains to be confirmed in a second cohort because it was not the main objective of the first study and because of the variable lead time of BAL sampling in this cohort of patients with ARDS (Quesnel et al, CCM, 2012). Furthermore, the correlation of the percentage of blood fibrocytes (Fsg%) with the percentage of alveolar fibrocytes (Fal%) remains unknown and their kinetics remain to be studied during ARDS evolution.

Hypothesis and Objective: We hypothesize that percentage of alveolar fibrocytes is a prognostic marker during ARDS. Our main goal is to confirm in a validation cohort that the % of alveolar fibrocytes measured in BAL fluid during the first 48 hours of ARDS evolution is associated with 28-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Ventilated patients with ARDS criteria as defined by Berlin criteria during the first 48 hours of evolution.

Exclusion Criteria:

* refusal of patient participation, pregnancy, HIV infection, Respiratory insufficiency, Pulmonary fibrosis, cirrhosis (\> Child B score), scleroderma, Alzheimer's disease, Bone marrow transplant, chemotherapy-induced aplasia, immunosuppressive therapy, Corticosteroids (\> 200 mg/day of hydrocortisone or equivalent in the two weeks preceding inclusion), End of life patient or IGS2 greater than 90, brain death, therapeutic limitation.
Resveratrol and Human Hepatocyte Function in Cancer

The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.

Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling pathway proteins will be measured using western blot analysis for protein expression and polymerase chain reaction for gene expression. Activation of signaling pathways in both native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on transcription factors that may be important in gene expression will be analyzed by transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell metabolism will be analyzed by proteomic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective liver resection for liver cancer

Exclusion Criteria:

* Inability to speak or read English
* Sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure
* History of daily alcohol intake
* Presence of human immunodeficiency virus
* Presence of significant renal dysfunction as defined by baseline serum creatinine \> 2.0 mg/dl or need/impending need for chronic dialysis therapy
* Known allergy to the study medication
* Pregnancy, lactating women, women contemplating pregnancy during the study period
Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents

Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound (TVUS) upon graduation from an accredited program, although TVUS education in residency is not standardized. The objective of this study is to assess for improvement in transvaginal ultrasound knowledge among residents after viewing an educational DVD.

This is a multi-site prospective parallel randomized controlled trial using an educational DVD from the American Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"®, compared to routine education. All participants completed a pretest on transvaginal ultrasound images and principles. The intervention group repeated the test after viewing the DVD. During the trial, performing and logging transvaginal ultrasounds were encouraged. All enrolled residents repeated the test at 6-10 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* resident in obstetrics and gynecology at one of three sites

Exclusion Criteria:

* unable to consent
A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma

To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. histologically proven squamous cell carcinoma of the thoracic esophagus
2. pathologic stages IIa, IIb, III except T4
3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. no previous history of chemotherapy nor radiotherapy
5. an essentially normal clinical laboratory profile (white blood cell count or WBC, \>=4,000 /mm3; hemoglobin or Hb, \>=10g/dl; platelet count or Plt, \>=100,000 /mm3; total serum bilirubin\<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, \<=1.2 mg/dl; creatinine clearance or CCr, \>=60 ml/minute; and arterial oxygen tension or PaO2, \>=65 torr
6. oral or written informed consent obtained before randomization

Exclusion Criteria:

1. severe heart diseases
2. uncontrollable hyper tension or diabetes mellitus
3. severe pulmonary dysfunction
4. HBs positive
5. active bacterial infection
6. synchronous or metachronous (within 5 years) malignancy
7. pregnant female
8. psychiatric medication
Comparison of Efficiency of Interferential Current Application Methods in Chronic Neck Pain

The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes.

Neck pain is quite common in the adult population and is a frequent reason for seeking medical attention. The prevalence of neck problems has increased with modern lifestyle changes. In individuals with neck pain, symptoms may resolve on their own within a few weeks, but approximately 30% of cases can become chronic. Neck pain lasting 1-4 weeks is considered acute; 4-12 weeks is subacute; and neck pain persisting for 12 weeks or more is considered chronic. Interferential current therapy is used in the treatment of chronic neck pain and is one of the physical therapy methods with analgesic effects. It is widely used around the world. Interferential Current Therapy can be applied using two types of electrodes: vacuum electrodes and carbon-silicon pad electrodes.The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic neck pain lasting at least 3 months
* Ages between 20 and 50 years

Exclusion Criteria:

* Patients with inflammatory or infectious diseases and those with radiculopathy or myelopathy symptoms
* Patients for whom electrotherapy is contraindicated (e.g., those with pregnancy, neurological conditions such as epilepsy, inner ear hearing aids, arrhythmias, pacemakers, active infections, skin lesions, etc.)
* Individuals with a history of malignancy, major surgery, or previous trauma
* Individuals who have received physical therapy within the last year
* Patients whose evaluation could not be completed for any reason
* Patients who do not wish to complete their evaluations for any reason
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer

The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.

1. Primary objective:

   Evaluate the CCR rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dMMR/MSI-H subgroup)
2. Secondary objectives:

   2.1 Evaluate the 2-year anal preservation rate, recurrence rate, quality of life, DFS and OS 2.2 Explore the subgroup of patients suitable for observation.
3. Outline:

Patients after long-course chemoradiation are grouped based on their MSI-H/dMMR status. For patients with MSI-H/dMMR, consolidation immunotherapy of Tislelizumab (BGB-A317) will be assigned. For patients with MSS/pMMR, consolidation chemotherapy will be given according to their tumor response. After completion of consolidation therapy, those who reach clinical complete response will receive organ preservation (watch and wait) strategy in place of radical surgery. During treatment, once local regrowth occurs or poor tumor response, total mesorectal excision (TME) surgery will be performed.

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T2-4 and/or N+, inappropriate for local excision
* the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
* Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
* without distance metastases
* aged between 18 to 75 years old.
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline CEA\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7
Characterization of Long Covid Pain in Primary Care

Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Prevalence data and the underlying mechanisms of such pain are very limited in the scientific literature. Therefore, with this research we will try to answer these questions.

Main objective: to determine and characterize persistent musculoskeletal pain in Covid-19 patients.

Method: two phases. First, a descriptive cross-sectional study will be carried out to estimate the prevalence of Long Covid Pain (LCP). Second phase, a case-control study will be carried out using the sample obtained in the first phase as the population. The sample will be divided into two groups: post-Covid-19 patients with LCP and post-Covid-19 patients without persistent pain (control group). The two groups will be matched according to sex, age and level of severity of the pathology.

An assessment and comparison between groups will be made of the following variables: central sensitization, healthy physical condition and blood test values, which will be evaluated by means of physical examination, questionnaires and laboratory tests.

Applicability of the results: this is a pioneering project at the national level, which would determine more reliably the prevalence of LCP in postcovid and could be a first step in the search for the best therapeutic strategies for these patients. This would help to improve the quality of life of these patients and to better manage the social and healthcare resources used in their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had Covid-19, with a confirmatory PCR+ test or positive antigen test and recorded in their primary care medical record.
* Subjects between 18-70 years old.
* Musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection.
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* History of chronic musculoskeletal pain of more than 12 weeks of evolution prior to Covid-19.
* History of diagnosed major depression.
* Having a diagnosis of fibromyalgia prior to Covid-19 infection.
* Pregnancy.
* Pain of oncologic origin.
* Fracture or surgical intervention on the spine in the last year.
* Bladder or bowel incontinence.
* Saddle anesthesia.
A Study of BPI-452080 in Subjects With Solid Tumors

This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists
* Dose expansion phase:

Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors

* Adequate organ function
* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase

Exclusion Criteria:

* Has received prior treatment with another HIF-2α inhibitor
* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc
* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
* Pregnancy or lactation