cyrilzakka/clinical-trials huggingface dataset:
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-

Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.

These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.


Eligibility Criteria:
Inclusion Criteria for MNPs patients:

* Age \> 18
* Establish MNPs Phi- diagnosis (ET, PV, MFP)
* Consent to participate

Inclusion Criteria for healthy volunteers:

* Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count
* No personal thromboembolic history
* No known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (Atrial fibrillation, etc.)
* Not pregnant
* Non smoker
* For women, no hormonal contraceptives

Exclusion Criteria for MNPs patients:

* Pregnancy
* Patient unable to give consent
Computed Tomography in Detecting Movement of the Esophagus in Patients Undergoing Radiation Therapy to the Chest

RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT scan), done before and after radiation therapy to help detect movement of the esophagus may help doctors plan the best treatment.

PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in patients undergoing radiation therapy to the chest.

OBJECTIVES:

* Determine the inter- and intra-fraction movement of the esophagus using CT scans in patients undergoing thoracic radiotherapy.

OUTLINE: This is a pilot study.

Patients undergo CT scans at baseline and then once weekly during their scheduled radiotherapy sessions to determine esophageal placement while in the treatment position. CT scans are performed before and after the radiotherapy session. Pretreatment and post-treatment scans are compared.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning to undergo definitive thoracic radiotherapy

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No concurrent palliative thoracic radiotherapy

Surgery

* Not specified

Other

* Concurrent participation in other clinical trials allowed
Safety Profile of Hydroxyethyl Starch

The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.


Eligibility Criteria:
Inclusion:

* patients with ASA risk score ≤ III,
* non-emergency patients, i.e. elective surgery

Exclusion:

* contraindications as listed for HES 130/0.42
Understanding Substance Use and Incident HIV/STI Among Young Black MSM

The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta.

Young black men who have sex with men (YBMSM) are a critically at-risk population in the United States and Atlanta that faces extremely high incidence rates of HIV and other sexually transmitted infections (STIs). The understanding of what places this group of men at high risk is incomplete, and the role of substances in amplifying that risk is unclear. This study will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV risk. The study includes several innovative aspects. First, the investigators are using a theoretical framework to understand multilevel associations between substance use and HIV risk behavior in YBMSM in the southeastern United States, a critically at-risk but understudied population. Second, the investigators are using a variety of enhanced measurement methods to understand these associations. The investigators are supplementing self-reported substance use with objective measures to enhance the sensitivity of classifying recent use. The investigators will analyze incident HIV/STI endpoints in addition to self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic measures of substance use and its covariates, which will capture both sexual and non-sexual contexts of use. Although previous cohort studies have explored alcohol and drug use during sexual events among men who have sex with men (MSM), few studies have described both sexual and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have incorporated longitudinal biomarkers of substance use and related these to incident infection outcomes. Finally, the investigators are using a mixed-methods approach to provide context to the quantitative findings. By recruiting subjects to a nested qualitative study within the larger cohort based on their interval-specific risks, the investigators will gain in-depth information regarding the emergence, persistence, and resolution of these complex relationships between substances and sexual risk behaviors among YBMSM and how these relationships emerge and are resolved over time.

Eligibility Criteria:
Inclusion Criteria:

* male at birth
* currently identifies as male
* age ≥18 years and \< 30 years at enrollment
* had anal sex with a man in lifetime
* has had any sex with a man in the past 3 months
* self-reported race is black/African American
* lives in Atlanta area and plans to remain for 2 years
* is able to complete the survey instruments in English
* is willing to provide at least 2 means of contact
* is willing to be re-contacted for the return of HIV/STI testing results, and for other study reasons as necessary
* is not enrolled in an HIV prevention trial

Exclusion Criteria:

* self-reported multiple or non-Black/African American race(s)
* self-reported Hispanic ethnicity
* (for prospective follow-up) participant screens HIV-positive
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease

This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted for 36 months in patients with optic nerve diseases.

Optic Nerve Diseases: Conditions which produce injury or dysfunction of the second cranial or optic nerve, which is generally considered a component of the central nervous system. Damage to optic nerve fibres may occur at or near their origin in the retina, at the optic disk, or in the nerve, optic chiasm, optic tract, or lateral geniculate nuclei. Clinical manifestations may include decreased visual acuity and contrast sensitivity, impaired color vision, and an afferent papillary defect. primary out put of clinical study is to measures Improvement in visual loss and improvement in idiopathic intra cranial.This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted for 36 months .

Eligibility Criteria:
Inclusion Criteria:

* Patient Should suffer from Optic Nerve diseases Like Diabetic Retinopathy, retinal pigmentation
* age in between 18 to 50
* Willingness to undergo Bone Marrow derived autologous cell therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the require Informed consent form(ICF) for the study.
* A ability and willingness to regular visit to hospital for protocol and follow up.

Exclusion Criteria:

* Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect including Syphilis, clinically relevant polyneuropathy) etc.
* History of Life threatening Allergic or immune- mediated reaction
* Haemodynamically Unstable.
Study of Glasgow Coma Scale in Neurological Patients

The assessment of the level of consciousness in patients admitted to intensive care units (ICU) can be complicated because the variables that are evaluated can be interpreted in a different way by different observers.

The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses and assess whether professional experience change the results. Secondary objective: to determine interobserver agreement in each of the three components (motor response, verbal and eye opening) of the GCS

Prospective observational study conducted in a multi-unit 18 beds, neurological and / or neurosurgical patients are included. Variables: Demographic, reason for admission, overall and its components GCS. The neurological assessment was performed by a minimum of 3 nurses. One of them applied algorithm and evaluation technique and all agreed independently valued response to stimuli. Interobserver agreement measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) of 95%. This study was approved by the Ethics Committee of Clinical Trials hospital.

Eligibility Criteria:
Inclusion Criteria:

* neurologic patients

Exclusion Criteria:

* pregnants, under-ages
Predictive Model for Postoperative Complications in Hemi-hip Arthroplasty

The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.

We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.

Eligibility Criteria:
Inclusion Criteria:

* A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty

Exclusion Criteria:

* 1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization
Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Purpose:

1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning)
2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener
3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements


Eligibility Criteria:
Inclusion Criteria:

* \> 65 years old
* Scheduled for TAVI surgery
* Able to play games on a tablet
* For usability part \> MoCA score of 26 or higher
* Near native dutch speaker

Exclusion Criteria:

* Mental disorder (unable to play games)
* Alcohol abuse (women \<15 and men \>22 alcoholic drinks/week)
* No informed consent
* Atrial fibrillitation (for ultrasound doppler)
Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings

The term adenoids describes lymphoid tissue on the superior and posterior walls of the nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged, adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice, and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease. Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through Eustachian tube dysfunction or chronic adenoidal infection.

Methods for identification of adenoid hypertrophy include the clinical history, examination, imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of the nasal cavity with dynamic evaluation of any nasal airway obstruction.

Objectives :

The aim of this study is to prospectively examine invasive and non-invasive office procedures to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal endoscopy.

Methods :

Prospective, observational study in pediatric patients aged 2-18 that will be referred to the otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed consent.

1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will be evaluated at the clinic, as described by Paradise grading system.
2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the patients had them at the time of referral. Adenoidal obstruction will be assessed by Fujioka's Adenoid-Nasopharynx ratio.
3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be assessed by Parikh grading system.


Eligibility Criteria:
Inclusion Criteria:

* age 2-18
* performed lateral cervical radiograph
* nasal obstruction
* signed informed consent by caregiver

Exclusion Criteria:

* previous adenoidectomy
* recent upper airway infection
* anatomic anomaly
* allergic rhinitis
* known obstructive sleep apnea
Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift

The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.

The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.

- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.

After assessment, one of the following techniques will be selected:-

* Liposuction only.
* thigh lift.
* Liposuction assisted thigh lift.

Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.

The same measurements mentioned above will be recorded for the patient group before surgery.

Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.

Informed consent will be signed by the patient before surgery illustrating possible risks and complications of the surgery.

Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding patient satisfaction and achievement of symmetry.

Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.

Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.

Postoperative measurements and photographs will be recorded and compared with preoperative ones.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals between18 and 35 years for control group and more than 18 years for patient group .
2. Patients with BMI between 19 and 25 for control group and less than 35 for patient group.

Exclusion Criteria:

1. Individuals less than 18 years.
2. Patients undergoing bariatric surgery within a period of less than one year.
3. Patients with BMI more than 35.
4. Patients with systemic illness as cancer or mental disorders \& hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.
Interaction Between NGF and Acute Exercise-induced Ischemia

The purpose of this study is to investigate pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.

Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.

It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and pain free volunteers

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, mental illnesses, or psychiatric diseases.
* Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
* Participation in other pain trials throughout the study period
* Lack of ability to cooperate
* Taking any analgesic 24 hours before the injections
* Performing any strenuous leg exercise through out the study period causing sore muscles
A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)

Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy

This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 75 years of age , with ≥ 40Kg
* Histological or cytological confirmed colorectal cancer
* ECOG performance status of 0-1
* Standard regimen failed or no standard regimen available
* Adequate hepatic, renal, heart, and hematologic functions
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Signed and dated informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

* - Pregnant or lactating women
* Any factors that influence the usage of oral administration
* Evidence of CNS metastasis
* Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
* Abuse of alcohol or drugs
* Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
* Disability of serious uncontrolled intercurrence infection
* Proteinuria ≥ 2+ (1.0g/24hr)
* Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
* Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
* Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
* Bone fracture or wounds that was not cured for a long time
* Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy

Exclusion Criteria:

* unable to give informed consent
* contraindication to MRI or MRI contrast agent
* claustrophobia
* renal impairment
* prior hormonal or radiation therapy for prostate cancer
* active prostatitis
* moderate to severe rectal inflammation
* previous rectal surgery
* prostate biopsy within 4 weeks of planned MRI