cyrilzakka/clinical-trials huggingface dataset:
BAY86-9766 Plus Gemcitabine Phase I Study in Asian

This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.

Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy
* Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) \</=1.

Exclusion Criteria:

* History of cardiac disease
* Active clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2
* Known human immunodeficiency virus (HIV) infection
* Uncontrolled seizure disorder
* Undergoing renal dialysis
* Known bleeding diathesis
* History of organ allograft
* Pregnant or breast feeding women
Stress Ulcer Prophylaxis in the Intensive Care Unit

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.

Eligibility Criteria:
INCLUSION CRITERIA:

* Acute admission to the ICU
* Age ≥ 18 years
* One or more of the following risk factors:

  * Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure \< 90 mmHg, mean arterial blood pressure \< 70 mmHg or lactate \> 4 mmol/l)
  * Acute or chronic intermittent or continuous renal replacement therapy
  * Invasive mechanical ventilation which is expected to last \> 24 hours
  * Coagulopathy (platelets \< 50 x 109/l or international normalized ratio (INR) \> 1.5 or prothrombin time (PT) \> 20 seconds) documented within the last 24 hours
  * Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
  * History of coagulopathy (platelets \< 50 x 109/l or INR \> 1.5 or PT \> 20 seconds) within 6 months prior to hospital admission
  * History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history)

EXCLUSION CRITERIA:

* Contraindications to PPI
* Ongoing treatment with PPI and/or H2RA on a daily basis
* GI bleeding of any origin during current hospital admission
* Diagnosed with peptic ulcer during current hospital admission
* Organ transplant during current hospital admission
* Withdrawal from active therapy or brain death
* Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
* Consent according to national regulations not obtainable
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)

Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection

The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.

Eligibility Criteria:
Key Inclusion Criteria:

Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis

Key Exclusion Criteria:

Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.

Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had histologically confirmed ESCC.
2. Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.
3. Patients for whom tissue samples are available
4. Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.
5. Written informed consent following full study information is provided to the patient.

Exclusion Criteria:

1. Patients lacking clinical information within 2 years of surgery.
2. Patients with multiple cancers.
Protocol Lab for Online Trials-Delphi

The Protocol Lab for Online Trials-Delphi (PLOT-D) module will use an online three-round Delphi combined with Participatory action research to inform the development of a multi-use protocol template to use in writing protocols for self-recruited online trials of interventional self-management. The Delphi will include an embedded randomized controlled trial to test how and if stakeholders adapt their views based on the contributions of others inside or outside the groups with which they are familiar.

The research aims to provide support for citizens to work alongside researchers to build participatory health trials online (any randomized trial that uses the internet for a health or wellness intervention). Tools to develop methods to run quality online trials protocols are needed. Also, help for adapting guidance to include the public and patients as partners in research for online trials is limited. The purpose of this work is to facilitate improved practice within protocol writing for participatory online trials.

Public and patient involvement (PPI), is one method used to conduct participatory research. PPI actively engages communities or individuals and moves beyond educating, engaging or doing interviews with research participants and does the research with them as partners. There is growing consensus that PPI is of value to researchers, industry, regulators, and members of the public.

There is an active discussion that is without substantial evidence for when the optimal time in the research process is to start PPI and whether patients and the public should join the research team, act as advisors, or have everyone contribute perspectives and work with their roles or peer groups.

The embedded study within the Delphi explores how working with stakeholder feedback in different ways may influence decision ranking as well choice similarities and differences

Eligibility Criteria:
Inclusion Criteria:

* Protocol lab for online trials Delphi (PLOT-D) participants

Exclusion Criteria:

* None if inclusion criteria are met
Predicting Outcome Following Standardized Exercise Therapy in Knee Osteoarthritis Patients

Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. Mechanistic pain profiling aims to identify the underlying mechanisms in the peripheral and central nervous systems, which are associated to the clinical pain.

In addition, the mechanisms underlying the pain relieving effect of standardized exercise therapy are largely unknown, but it is hypothesized that they are linked to the patient's ability to activate the descending pain inhibitory pathways (conditioned pain modulation, CPM) in the central nervous system. Mechanistic pain profiling including CPM have been used prognostic to identify responders to treatment, but these measures as a prognostic tool for standardized exercise therapy has not been investigated.

The primary aim of this study is to investigate if mechanistic pain profiling alone or in combination with clinical pain measures before standardized exercise therapy can predict the patients' pain reduction following the exercise therapy program


Eligibility Criteria:
Inclusion Criteria:

* The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)

Exclusion Criteria:

* Known factors to influence pain and pain sensitization
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.

Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
* At least 18 years of age.
* ECOG PS 0\~1
* Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
* neutrophil ≥ 1.5 x 109 /L, Hemoglobin \> 90 g/L, Platelet count \> 100x109/L.
* Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST \< 2.5 x upper limit of normal without liver metastasis, ALT and AST \< 5 x upper limit of normal with liver metastasis. Serum creatinine \< 1.5 x upper limit of normal.
* Urine pregnancy test is negative for woman.
* Estimated life expectancy is at least 3 months.
* Patient comply with the clinical trial protocal.
* Informed consent must be signed.

Exclusion Criteria:

* Patients who are currently undergoing other anti-tumor therapy.
* Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
* Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
* Central nervous system (CNS) tumor or metastatic tumor.
* Serious mental disorder.
* Serious dysgnosia.
* Other serious comorbidity.
* Alcohol or drug dependence.
* Previously allergic to drugs used in the study.
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.

Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.

Eligibility Criteria:
Inclusion Criteria:

* Under one year of age
* first episode of wheezing and dyspnea
* RSV antigen detected by ELISA
* parents signed informed consent.

Exclusion Criteria:

* infants with chronic lung disease
* cardiac disease
* other chronic conditions.
Effectiveness of KT VS ST Along With Routine Physical Therapy Among Patients of Chronic Low Back Pain RCT

To determine the effectiveness of Kineso taping (KT) Versus Sham taping along with routine physical therapy among Chronic Low Back pain (CLBP) patients.


Eligibility Criteria:
Inclusion Criteria:

Pain in the area between 12 ribs and hip crease with or without leg pain. Age ranges from 18 to 65 years. Low back pain for 6 weeks. Moderate pain intensity with pain score.

Exclusion Criteria:

Known or suspected Spinal lesions. Spinal surgery within first 6 months. Physical Therapy for low back pain for past 6 months. Severe Complications.
The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial

The purpose of this randomized clinical trial is to investigate the impact of physical therapist-directed exercise counseling combined with fitness center-based exercise training on stage of exercise behavior in people with type 2 diabetes.

Type 2 diabetes is a chronic, metabolic disease characterized by hyperglycemia resulting from insulin resistance. Research studies indicate that complications such as cardiovascular disease, peripheral vascular disease, retinopathy, and loss of physical function are associated with type 2 diabetes. Clinical management of people with type 2 diabetes consists of medical nutrition therapy, pharmacological therapy, and exercise. Exercise has been shown to improve risk factors associated with complications of type 2 diabetes such as elevated plasma glucose, elevated blood pressure, loss of muscular strength, and loss of exercise capacity. In fact, the American Diabetes Association and American College of Sports Medicine have published position statements recommending the use of exercise, specifically resistance and aerobic training, as an intervention for people with type 2 diabetes. However, 31 percent of people with type 2 diabetes have reported no regular physical activity and an additional 38 percent have reported less than recommended levels of physical activity. Therefore, interventions to promote regular exercise behavior in people with type 2 diabetes are clinically important by potentially preventing type 2 diabetes-related complications.

Previous studies have investigated the impact of exercise counseling on exercise behavior in people with type 2 diabetes. However, these studies have limitations such as lack of agreement with exercise training guidelines for people with type 2 diabetes and research design flaws. This current study investigates the effect of a novel, physical therapist-directed exercise counseling combined with fitness center-based exercise training intervention on stage of exercise behavior in people with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Consider medically stable to participate by a physician

Exclusion Criteria:

* Contraindication for exercise testing
* Uncontrolled hypertension
* Proliferative retinopathy
* Severe peripheral neuropathy
* Nephropathy
* Autonomic neuropathy
* Unable to participate due to a physical impairment
* Fasting plasma glucose greater than 250 mg/dL
* Involved in resistance or aerobic training on 2 or more days per week
Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation

In degenerative cervical myelopathy (DCM) the dynamics of disease progression and the outcome after surgical decompression vary inter individually and do not necessarily correlate with radiological findings. By better characterization of the underlying pathophysiology this study aims to improve diagnostic power in DCM using Navigated transcranial magnetic stimulation (nTMS).

120 patients with DCM due to cervical spinal canal stenosis will be examined preoperatively and postoperatively with nTMS. On the basis of the initial Japanese Orthopedic Association (JOA) Score two patient groups will be established (JOA≤12/\>12). The resting motor threshold, recruitment curve, cortical silent period and motor area will be determined. Accordingly, 40 healthy subjects will be examined.

To the investigators knowledge, this study is the first to analyze changes of corticospinal excitability and reorganization in patients with cervical spondylotic myelopathy with navigated TMS. In the present study, there was a significant difference in parameters of excitability and motor area activation between the severely symptomatic and clinically stable patient group. The investigators analysis showed that chronic CSM induces a recruitment of the non-primary motor area and corticospinal disinhibition, so that axonal damage can be compensated through recruitment of new cortical and supplementary motor connections, to a certain degree. Upon exhaustion of these mechanisms further axonal damage translates directly into new neurological deficits. These results lay the ground for a novel concept in CSM, the "corticospinal reserve capacity".

This study lays the foundation for future research to examine the pathomechanisms in CSM. Functional reorganization occurs on a spinal as well as on a cortical level. The concept of the corticospinal reseve capacity describes a compensatory, increased recruitment of non primary motor areas and corticospinal disinhibition in order to preserve motor function. By detecting the degree of reorganization, a stratification for an unfavourable as well as stable clinical course could be made. This innovative approach to describe the pathomechanisms in CSM might revise current concepts of clinical diagnostics and might have an impact on future treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic/asymptomatic cervical spondylotic myelopathy scheduled for surgery (anterior and/ or posterior decompression) or conservative treatment. The radiological inclusion criteria are cervical spinal stenosis (C3-C7) associated with or without intramedullary high signal intensity lesion on T2-weighted MRI due to disc protrusion or spondylosis.
* healthy subjects without any neurological disease

Exclusion Criteria:

* Exclusion criteria are other pathologies in the vicinity of the corticospinal tract above the lesion site (i.e. tumor, infarction), neuroinflammatory disease, high grade paresis of the upper extremity (BMRC\<3), the existence of a cardiac pacemaker, deep brain stimulation electrodes or pregnancy.
Use of an Occlusal Support Device During the Second Stage of Labor

The primary objectives of this study are to determine if the use of an Occlusal Support Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor, reduce the incidence of labor complications including Caesarian Sections and improve Apgar scores in newborns

Prolonged labor, especially during the second stage of active expulsive effort (the pushing phase), is associated with increased risk of maternal complications (e.g. tissue trauma, postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist and maximize maternal expulsion effort should be of great value in reducing the number of complications, also including cesarean section or instrumental deliveries. Past studies published in the dental literature have shown that specially designed oral appliances that support the dental occlusion may increase the isometric strength of different muscle groups. Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor. Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either the study group (Dental appliance) or the no dental appliance group. Duration of labor will be measured for both phase I and phase II. Rates for cesarean section and instrument deliveries and other complications will be charted as well as Apgar scores .

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Uncomplicated pregnancy
* Singleton pregnancy

Exclusion Criteria:

* Unable to provide informed consent or comply with study protocol,
* High risk and/or complicated pregnancy,
* Have multiple fetuses as diagnosed by ultrasound,
* Have extensive decay or multiple broken/missing teeth that will interfere with the fabrication of an OSD