cyrilzakka/clinical-trials huggingface dataset:
The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period.

The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days. Dosing will either be administered twice or three times daily. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

An informed consent document signed and dated by the subject

Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* 12-lead ECG demonstrating QTc \>450 msec at screening.
* If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
* Females of child bearing potential.
* Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Optic Nerve Sheath Diameter Difference

Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position).

This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.

According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia. Previous reports showed that epidural pressure varies according to different posture. When epidural pressure was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure than epidural pressure of lumbar extension. In addition, when epidural pressure was measured in the sitting position, it showed lower pressure than pressure of lateral decubitus.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain surgery
Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease

The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE ISCHEMIC HEART DISEASE as topographical correlation between ischemic territory injury and coronary angiography.

Assessing the accuracy of Cardio-RM identifying ischemic territories and their correspondence to the presence of critical coronary lesions, comparing the presence, extent and regional inducible ischaemia in the Cardiac-MRI with the presence and characteristics of vascular lesions in coronary angiography.

In particular, the study aims to evaluate the correlation between topography and function of the ischemic area revealed by the resonance and coronary artery disease documented coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

1. patients with suspected ischemic heart disease or recurrent Myocardial ischemic symptoms defined as:

   * presence of:

     * chest pain related to the effort lasting 5-20 minutes, and / or
     * positive stress test for inducible Myocardial ischemia
   * presence of at least one of the following risk factors: smoke family history of cardiovascular disease hypertension dyslipidemia diabetes mellitus NID / ID
2. no contraindications to perform coronary angiography
3. informed written consent to the processing of personal and sensible data, signed and dated by the patient.

Exclusion Criteria:

* Unstable angina;
* Severe aortic stenosis
* Hypertrophic cardiomyopathy
* Pacemaker and \\ or defibrillator
* Coronary stent implantation in 90 days before Cardiac MRI
* Intracranial metal clips
* Severe hypertension (systolic blood pressure\> 240 mmHg, and diastolic blood pressure above 120 mmHg)
* Ventricular thrombosis and \\ or atrial
* Aortic aneurysm and \\ or aortic dissection
* Myocarditis, endocarditis, pericarditis
* Critical stenosis of the left notes
* State of severe anxiety or claustrophobia
* Contraindications to the use of atropine (BAV advanced glaucoma, pyloric stenosis, prostatic hypertrophy)
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage

The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with singleton fetus
* Gestational age 34-42
* With or without known hemoglobinopathy

Exclusion Criteria:

* Known risk factor for fetal maternal hemorrhage
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery

The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids \[morphine like medications\] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Participants who will undergo elective spine or orthopedic (related to bones) surgery
* Participants who are expected to have moderate (medium level of seriousness) or severe (very serious) pain requiring parenteral (given by injection) opioids (morphine like medications) for at least 48 hours after surgery
* Participants who have been admitted to the Post Anesthesia Care Unit (PACU) after general anesthesia, spinal anesthetic of less than 4 hours duration of action or epidural (outside the spinal cord) anesthesia
* Participants who are alert and breathing spontaneously for at least 30 minutes in the PACU
* Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures

Exclusion Criteria:

* Participants with active systemic skin disease or active local skin disease that prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS) application
* Participants with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride
* Participants who received regular treatment with transdermal strong opioids within 14 days prior to surgery
* Participants who are known or suspected to have abused any drug substance or alcohol
* Participants who will probably require additional surgical procedures within 72 hours
Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer

This study is conducting an evaluation of two chemotherapy drugs, Velcade and Irinotecan, in women with advanced, recurrent, or metastatic cervical cancer, vaginal cancer, or vulvar cancer. Patients with cervical cancer may have received a platinum-containing treatment as systemic therapy without radiation, but is not required.

This is a phase 2 study. Patients with advanced or metastatic histologically documented squamous cell carcinoma, adenocarcinoma, or adenosquamous cancers originating in the cervix, vagina, or vulva will be eligible. Measurable disease by either clinical exam or radiography is also required. Patients receiving cisplatin-based chemoradiation as definitive treatment for local disease will be eligible. Patients must have no more than one prior platinum-based chemotherapy regimen in the metastatic setting. Patients presenting with distant metastatic disease (beyond the pelvis) will be eligible, as long as they are not eligible for a higher priority study.

Eligibility Criteria:
Inclusion Criteria

* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* age \> 18
* Karnofsky performance status \> 60%
* Measurable disease on clinical exam or by RECIST criteria
* One prior platinum-based systemic chemotherapy regimen for advanced disease is allowed but not required. Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen and is also allowed. Patients eligible for a higher priority study will be excluded.
* Life expectancy \> 6 weeks
* Peripheral neuropathy ≤ Grade 2 by CTC 3.0 criteria
* Women of child-bearing potential must have a negative pregnancy test
* Adequate hematopoietic function defined as: ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.
* Adequate renal and hepatic function defined as: Bilirubin ≤ 1.5 times upper limit of normal (ULN); SGOT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; Creatinine ≤ 2 times ULN.

Exclusion Criteria

* Patient has hypersensitivity to bortezomib, boron or mannitol.
* Female subject is pregnant or breast-feeding.
* Patient has received other investigational drugs with 14 days before enrollment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Prior treatment with CAMPTOSAR or VELCADE
* More than one prior treatment for metastatic disease.
* Concurrent uncontrolled illness
* Ongoing or active infection
* History or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers
* Psychiatric illness or social situation that would preclude study compliance.
Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.

The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

This is a Retrospective study evaluating the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

Eligibility Criteria:
Inclusion Criteria:

- DICOM images from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure

Exclusion Criteria:

* N/A
Study on Microflora Characteristics of Pancreatic Solid Lesions Via Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy

Study objective: To describe the microflora characteristics of the pancreatic solid lesions via the tissue acquired via the endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B).

Study design: This is a prospective observational study.

This is a prospective observational study. Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions (pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis, etc)will be successively included in this study. The EUS-FNA/B procedures will be accomplished in the standard way after the puncture site is washed with 20ml sterile saline for three times. The remaining fresh tissue after sufficient specimen collected for the diagnosis will be stored in - 80℃ fridge. DNA is extracted from all samples using the suitable kit and V4 16S rRNA gene sequencing is performed on all samples. The investigators ran "Decontam" (Davis NM, et al. Microbiome 2018;6:226) in order to identify and remove contaminant DNA sequences from the dataset. And the microbiome is analyzed with the standard methodology. The investigators tend to describe the microflora characteristics of pancreatic solid lesions and try to compare the differences between cancer and benign diseases.

This study will carry out in two stages: the preliminary stage, 10 patients will be included. If the technic success rate (successful extraction of DNA and sequencing of 16s rRNA after bioinformatical removal of potential DNA contaminations via the use of 'Decontam') is high than 50%, the successive inclusion progress \[the main stage\] will last for one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.
* Age ≥ 18 years and \< 80 years.

Exclusion Criteria:

* Including but not limited to: poor general conditions, severe cardiopulmonary disease, difficult to tolerate EUS examination; coagulation dysfunction; platelets \<50×10\^9/L
Weight Reduction With the Low-Insulin-Method

Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 weeks.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 25 kg/m2

Exclusion Criteria:

* none
Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention on reducing sedentary behavior and increasing physical activity among adolescents and to investigate the engagement in the exergame. This will be compared in three groups: an intervention group that will receive a tailored exergame; an active control condition that will receive a non-tailored exergame; and a passive control condition that receives no intervention.

The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention with tailored feedback on sedentary behavior and physical activity among adolescents and to investigate the engagement in the exergame. One intervention group will receive a version of the exergame that tailors feedback. This means tailored feedback will be based on data from a sensor which is integrated in a T-shirt and paired to the game. The active control group will receive a different version of the game, that does not provide tailored feedback.

Both groups will be compared to investigate their level of engagement in the game. A passive control group will be included that will be asked to continue their daily routines as usual. All three groups will be compared to determine the effectiveness of the 'SmartLife' intervention on physical activity and sedentary behavior.

Eligibility Criteria:
Inclusion Criteria:

* Between 12-18 years old
* Access to an Android smartphone (4.0.1) during study period
* No physical disabilities that hinder physical activity

Exclusion Criteria:

* Not Dutch-speaking
* Does not have access to an Android smartphone (4.0.1)
Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia

The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* dysphagia
* first episode of stroke

Exclusion Criteria:

* swallowing disorder before stroke
* previous episode of stroke
* MMS \< 20 no consent
Effects of Conventional Physical Therapy With and Without Scapular Stabilization Exercises in Adhesive Capsulitis.

The objective of this study will be to determine the Effects of conventional physical therapy with and without scapular stabilization exercises on pain, function, scapular dyskinesia, and proprioception in patients with adhesive capsulitis.

Adhesive capsulitis is characterized by the gradual onset of severe shoulder pain with the progressive limitation of active and passive glenohumeral range of motion. Due to capsular tightness and pain, scapular positioning and proprioception get affected. An increase in the abnormal positioning of the scapula and proprioception deficit disturbs the whole biomechanics of the shoulder joint and are the main causes of residual pain and stiffness following PT treatment.

In previous studies, several studies have reported the effects of scapular stabilization exercises on pain, ROM, and function but there is a paucity of literature available on specifically addressing scapular dyskinesis and joint position sense in patients with adhesive capsulitis. Scapular stabilization techniques will help to improve proprioception and the length-tension relationship of the scapular muscles, which may effectively reduce the time taken for the rehabilitation of the patient with adhesive capsulitis of the shoulder joint.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic adhesive capsulitis for more than 4 months (Stage 2)
* Unilateral idiopathic adhesive capsulitis
* Shoulder Pain on NPRS ≥5
* Restricted ROM (loss of ≥ 25% relative to non-involved shoulder in one or multidirectional)
* Patients volunteered to participate in the study and signed informed consent.

Exclusion Criteria:

* History of shoulder surgery or manipulation under anesthesia
* Unstable fractures, rheumatoid arthritis and those with severe joint pain unrelieved by rest
* Neurologic deficits affecting shoulder functioning during daily activities
* Pain or disorders of the cervical spine, elbow, wrist, or hand
* Other pathological conditions involving the shoulder (rotator cuff tear, tendinitis, etc.)
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.

Eligibility Criteria:
Inclusion Criteria:

1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;

   o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)
2. mitral valve disease requiring surgical disease

Exclusion Criteria:

1. the need for prosthetics of two or more valves
2. patients with a decrease in LVEF of less than 45%;
3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
5. the diameter of the ascending aorta is more than 45 mm;
6. unwillingness of the patient to participate in the study.