cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer

Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors leading to limb amputation, it was reported that the amputation rate is 15 times of the non-diabetic patients. Common surgical amputation is not only about high plane amputation but also bring a tremendous mental stress to patients which may affect the quality of life seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia , and septic shock which could be the main cause of death before amputation. It become an important topic that how to control the infection, reduce the amputation plane, save the function as possibility, and improve the life quality of the patients as well.

This study is based on years of clinical experience of and brings out "early-stage amputation" concept firstly in China with a systematic exposition, experimental research and clinical research. Early-stage amputation refers to cut in the normal tissue from the inflammatory tissue at the junction line of limbs, in order to achieve more retained stump, block endotoxin absorption and improve the quality of life of patients. External therapy of herbs chitosan can promote granulation tissue regeneration and control of local infection, it solved the problem of difficult wound healing and it is a reliable guarantee of early-stage amputation.


Eligibility Criteria:
Inclusion Criteria:

1. According to Chinese herbs medicine standard for the diagnosis and treatment of diabetic foot, the individual diagnosed as diabetic foot with acromelic gangrene.
2. The individual aged between 18 and 70 years.
3. All wounds corresponded to Wagner classification grade 4 or 5.
4. By appropriate treatment, skin temperature of limb with ulcer became warmer and it proved that the blood circulation recovery could be happening.
5. There were no obvious bruises or chromatosis in the necrosis skin.
6. Persistent limb pain affected the sleep of the individuals.
7. The individual voluntarily signed the informed consent form.

Exclusion Criteria:

1. Acromelic gangrene caused by other reasons.
2. The individuals with server cardiovascular and cerebrovascular diseases or hepatic and kidney diseases do not adhere to surgery.
3. The individuals with the history of amputation.
4. The individuals with systemic inflammatory response syndrome, Bacteremia, Pyemia or shock.
5. Vascular ultrasound shows artery is completely blocked.
6. The individuals do not adhere to the treatment or are with other treatments.
Stereotactic Body Radiotherapy for Spine Tumors

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years

Eligibility Criteria:
Eligibility Criteria:

* Patient age \>= 18 years
* performance status of 0-3
* Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
* Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
* Established histologic diagnosis of a benign or malignant tumor of the spine.
* Arteriovenous malformation of the spine identified radiographically (no biopsy)
* Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal segment
* Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor should not be within 5 mm of the spinal cord.
* If chemotherapy is planned, ideally it should not have been given within 30 days of starting radiation and should not resume until at least 2 weeks after completing radiation. In addition, it is not recommended to perform SBRT when targeted anti-angiogenesis therapy is planned within 2 months of the procedure.
* Signed study-specific consent form

Exclusion Criteria:

* Lesion involving \> 3 adjacent vertebral levels
* Overt spinal instability
* Neurologic deficit due to bony fragments/bony compression of neural structures
* Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s)
* Rapidly progressive spinal cord compromise or neurological deficit
* Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression
* Patient unable to undergo an MRI
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Dynamic ACL Brace: In Vivo Kinematics

The purpose of this study is to evaluate the effect of the Össur Rebound dynamic ACL brace on knee kinematics evaluated using dynamic stereo X-ray (DSX) imaging during functional activities. Brace performance will be evaluated before and after ACL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral, complete ACL (Anterior Cruciate Ligament) ruptures (must be documented by prior MRI)
* No other concomitant lower extremity injuries and an uninjured contralateral limb
* Acute ACL tears that will be scheduled for ACL reconstruction with Dr. Robert F. LaPrade
* Minimal swelling and pain
* Able and willing to perform the required study activities

Exclusion Criteria:

* Previous surgery or significant injury to either knee
* Relevant surgery, procedure, injury, or condition in the past two years which may affect knee pain or general movement patterns on either side
* Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health
* Women who are pregnant, or trying/planning to become pregnant during the next 10 months
* Known balance or vestibular disorders
* Persons with a history of significant radiation exposure, whether occupational or medical in nature (Anyone with a history of medical radiation therapy, for cancer or other conditions, is excluded from the study. Those who have an annual occupational radiation exposure greater than 25mSv may not enroll.)
* Persons with a pacemaker, hearing aid, aneurysm clip or artificial heart valve, or other forms of loose metal implants
* Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury, significant meniscal damage
* Allergy or sensitivity to silver or latex
* Adults lacking capacity to consent for themselves

Post-Op Visit Exclusion Criteria

* Participants who do not pass their return-to-sport test within 7-9 months of ACL-Reconstruction surgery will be excluded from the second phase of testing.
* Participants who no longer pass the MRI screening at the time of Phase 2 testing (for example, who have a new loose metal implant), will be excluded from the MRI portion of the testing only.
Correlation Between PSA Levels and F-18 PSMA PET/CT Findings in Prostate Cancer Patient

It is a cross sectional study aimed to correlate between PSA Levels and F-18 PSMA PET/CT Scan findings and to evaluate the impact of PET/CT findings on the patient management

Prostate cancer (PC) is a prevalent malignancy that occurs primarily in old males, it is the third most common with regards of mortality (1,2). prostate-specific membrane antigen (PSMA) known as glutamate carboxypeptidase II, is a transmembrane glycoprotein highly expressed in PC cells. PSMA expression tends to increase with increased pathological Gleason grade and is thought to be upregulated with the emergence of androgen independence (2).

PSMA PET/CT imaging is important for correct primary staging and for the detection of sites of biochemical recurrence.

prostate-specific antigen Liu et al., in 2022 stated that as serum PSA levels increase, the diagnostic accuracy of F-PSMA-1007 PET/CT also improves (3) Bergero et al., in 2022 evaluated the diagnostic correlation between PSA and positivity of F-18 PSMA PET/CT in patients with biochemically recurrent prostate cancer (RPC), reporting it as a very good predictor of positivity in 18F-PSMA PET/CT in patients with RPC (4).

A Meta-Analysis in 2022 found that the detection rate (DR) of the18F-PSMA-1007 PET/CT was also improved with increasing serum PSA levels (5) Another Meta-Analysis in 2019 studied the DR of F-18 PSMA PET/CT revealing that DR is related to PSA values with significant lower DR in patients with PSA\<0.5 ng/mL (6)

Eligibility Criteria:
Inclusion Criteria:

* Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications

Exclusion Criteria:

* Undifferentiated prostate cancer.
* Studies with motion artifacts, or those in which patient can't stay stable or calm during acquisition.
* Severely ill patients that hinder imaging.
Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥18 years
* T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)
* BMI of ≥27 kg/m2
* Weight stable (±3kg in the last 3 months)
* Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage
* Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period.

Exclusion Criteria:

* HbA1c concentration of ≥12%.
* Pregnant or lactating within the past 6 months or trying to become pregnant.
* Individuals following a vegetarian/vegan only diet
* Food allergies (to red meats or other common protein sources)
* Using exogenous insulin for T2D management
* Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study.
* Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
* Current Eating disorder (anorexia or bulimia)
* Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable.
* Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs

The research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or purchase prescription medications on the illicit market in a pilot study to be known as the Rhode Island Young Adult Prescription and Illicit Drug Study (RAPIDS). Participants will be trained to use a take-home home rapid drug test to test for the presence or absence of fentanyl in their drug supply. Half of the enrolled participants will be asked to test their urine for presence or absence of fentanyl, and the other half will be asked to test their drug residue for presence or absence of fentanyl. All participants will receive up to 15 take-home rapid drug tests for fentanyl. A follow-up survey will examine and compare utilization of the tests between the two groups. The study will be guided by the information-motivation-behavioral skills (IMB) model of engagement in health behaviors. The IMB model hypothesizes that if a person possesses the information, motivation, and behavioral skills to act, there is an increased likelihood that she/he will fulfill and maintain the desired behaviors (behaviors that will reduce accidental overdose).

The research team will administer a brief survey to ascertain behavioral, psychosocial, and clinical factors that may be related to non-prescription fentanyl (NPF) exposure among young people who use illicit drugs. The researchers will also characterize knowledge of and perceptions towards drugs contaminated with NPF, as well as the potential diversion of prescription fentanyl formulations (e.g., transdermal patches). After the interviewer-administered survey has been completed, participants will provide urine samples to determine recent exposure to NPF and other illicit drugs.

The research team will assess the acceptability and feasibility of "take home rapid drug tests" to test for fentanyl exposure among 100 participants from the target population. After the enrollment and baseline survey, participants will be provided with rapid drug tests that detect the presence or absence of fentanyl in their drug supply. Half the participants will be asked to test their urine to see if they have been exposed to a fentanyl-contaminated drug. The other half will be asked to test the residue of the drug that they intend to use. Study participants will then be asked to return in 2 weeks for a brief follow-up survey that will assess whether they used the self-tests, whether the technology was acceptable and easy to use, and whether and how a positive test result altered their drug-using and overdose prevention behaviors.

Eligibility Criteria:
Inclusion Criteria

* 18-35 years of age
* resident of Rhode Island
* able to complete interviews in English
* self-reported heroin, cocaine, injection drug use, or counterfeit prescription pill use in the past 30 days

Exclusion Criteria

-participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription
Long Term Evaluation of Primary Congenital Glaucoma Management in Sohag University Hospital

evaluation of primary congenital glaucoma management in sohag university hospital

long term evaluation of primary congenital glaucoma management in sohag university hospital

Eligibility Criteria:
Inclusion Criteria:

* children operated more than 3 months

Exclusion Criteria:

* other types of operated pediatric glaucoma
Comparison of Two Neuromuscular Monitors

Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Exclusion Criteria:

* Pregnancy or feeding
* Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation
* American Society of Anesthesiology \[4\] physical status
* Allergy or contraindication of neuromuscular blocking agents
ASTHMA (AntibioticS To Help Manage Asthma) Pilot Study

The ASTHMA Pilot Study is a randomized, controlled, parallel group clinical trial of 6 weekly doses of azithromycin (cumulative dose 4800 mg) or placebo as adjunctive treatment in addition to usual care for adults with stable persistent asthma, with final follow up at 3 months after completion of study medication.

The hypothesis to be tested is that antibiotic treatment will improve asthma at followup, and that this improvement will be limited to patients with evidence of C. pneumoniae infection.

The secondary hypothesis is that randomized, controlled treatment trials can be carried out successfully in a geographically dispersed practice-based research network.

Asthma is a chronic inflammatory bronchial condition of unknown etiology. Decades ago many clinicians believed that infection played a major role in asthma etiology, but current expert opinion favors the view that asthma is a noninfectious condition whose root cause is inflammation. Therefore chronic antiinflammatory therapy, mainly inhaled corticosteroids, is currently advocated as primary anti-asthma treatment. It is important to recognize, however, that antiinflammatory therapy is palliative, not curative.

A growing body of evidence implicates chronic bronchial infection with Chlamydia pneumoniae in the pathogenesis of asthma in both adults and children. Organism identification studies (culture and PCR) suggest that up to one-half of children with asthma may be chronically infected by C. pneumoniae, and seroepidemiologic studies in adults are consistent with chronic C. pneumoniae infection in the majority of adult-onset asthmatics. Furthermore, case reports and uncontrolled trials have provided provocative but inconclusive evidence that treatment of C. pneumoniae infection in both children and adults with asthma can favorably affect the natural history of this disorder.

We propose a randomized, placebo-controlled, triple-blinded study of antichlamydial antimicrobial therapy in adult-onset asthma. Results will help to determine whether antimicrobial therapy is effective in treating some adult asthma syndromes. Positive results would have significant public health implications. Methodologies developed for use in this trial may expedite future studies in practice-based research networks.

Eligibility Criteria:
Inclusion Criteria:

* adults with stable persistent asthma and evidence for reversible airway obstruction

Exclusion Criteria:

* macrolide allergy, pregnancy or lactation, specified comorbidities or medications
Copanlisib Pharmacodynamic Study

This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.


Eligibility Criteria:
* Histologically confirmed diagnosis of the following NHL: follicular lymphoma all grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) OR
* Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or PTEN alteration: Breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers
* Biopsy-accessible tumor
* Male or female patients equal 18 or more years of age
* NHL patients must have at least 1 bi-dimensionally measurable lesion according to the modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria
* Eastern Cooperative Oncology Group performance status 2 or \<
* Life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug
* Left ventricular ejection fraction \> or equal the lower limit of normal for the institution

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score \< or equal to 6 and prostate-specific antigen \<10 ng/mL, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\]
* Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed \<3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
* Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
* Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c \< or equal to 8.5% or fasting blood glucose \< or equal to 160 mg/dL
Inturlekin L33 in Ankylosing Spondylities Patients and Its Relation to Subclinical Atherosclerosis

detect level of Inturlekin 33 in ankylosing spondyilits patient

measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients

detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients

Ankylosing spondylitis (AS), a type of SpA, is an autoimmune disease that mainly involves, sacroiliac joints (SIJs) and their adjacent soft tissues, such as tendons and ligaments. The main clinical manifestations include back pain and progressive spinal rigidity as well as inflammation of the hips, shoulders, peripheral joints and fingers/toes. In addition, there are extra-articular manifestations.

Cardiovascular disease has become the first cause of death for patients with ankylosing spondylitis (AS).

Patients with ankylosing spondylitis (AS) have an increased cardiovascular morbidity and mortality . Accelerated atherosclerosis caused by a systemic inflammatory response has been reported to be an important risk factor for increased cardiovascular risk for autoimmune diseases.

Interleukin (IL)-33 is a cytokine belonging to the IL-1 family and was recently identified as a ligand for ST2, .the serum levels of IL-33/sST2 were remarkably higher in the patients with AS than the healthy groups .

Pervious studies confirm the importance of IL-33/ST2 axis in the process of atherosclerosis, and indicate its ambiguous function in immune response, whether as proinflammatory cytokine in advanced atherosclerotic lesions, or as profibrotic, in early lesions.

Previous study shows increased CIMT in AS patients without traditional cardiovascular risk factors compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed as Ankylosing Spondylitis
* Age (20-40)

Exclusion Criteria:

* Patients with other rheumatic diseases/other SPA types

  * Participants with history of CVD event in past or present
  * Patient experiencing cardiovascular revascularization surgery or cerebrovascular disorder within past 6 months.
  * Patient with other risk factor for atherosclerosis.