cyrilzakka/clinical-trials huggingface dataset:
MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine

The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.

Nerve ablation is used therapeutically to produce temporary anesthesia and diagnostically to locate the source of pain. Ablation, or purposeful destruction of tissue, relieves facet joint pain and pain related to nerve damage by disabling pain-transmitting nerves. Cryoablation for pain management is particularly useful when other modalities are too difficult to perform or have a high incidence for complications or side effects.

Currently nerve ablation is performed with bupivacaine and alcohol, but MRI-guided cryoablation of nerves and facets may result in superior efficacy and longer relief. Cryotherapy techniques provide long term analgesia and help alleviate intractable pain for patients with facet joint pain and neuralgia.

Minimally invasive Magnetic Resonance (MR)-guided ablation of nerves and facets may lead to decreased procedure time and increased relief of pain due to cancer or nerve degeneration. With the advent of the Advanced Multimodality Image Guided Operating Suite (AMIGO) at the Brigham and Women's Hospital, we have exceptional capabilities for minimally invasive image-guided procedures, including different ablation techniques. The AMIGO suite is equipped with hardware that will keep the patient stationary while the Magnetic Resonance Imaging scanner moves to the patient. Additionally, the monitoring software within the AMIGO suite allows clinicians to instantaneously analyze the imaging information which significantly reduces the risk of injury to adjacent structures.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be willing and able to sign a written informed consent document.
* Patients must have facet joint disease or pain due to a damaged or compressed nerve that would benefit from a minimally invasive image-guided procedure (i.e., adjacent to critical structures, better visualized under 3 Tesla MRI than CT)
* Subjects must be able to adhere to the visit schedules and attend pre and post imaging.
* Participants must be at least 18 years of age
* Participants must have an estimated life expectancy of \>8 weeks in the opinion of the clinician.

  * Patients with radiculopathy must have the cause of pain confirmed by a nerve block within 3 months prior to ablation

Exclusion Criteria:

* Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate \<60ml/min, metal clips)
* Pregnant or breastfeeding woman are excluded from this research.
Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer

The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane \[18F-FMISO\]) PET/CT and expression of HIF-1-alpha could predict response of primary endocrine therapy in ER-positive breast cancer

Approximately 30% of ER-positive breast cancer will unfortunately display primary resistance to hormonal therapy, and some may develop acquired resistance to the therapy after initial treatment. Hypoxia is a normal phenomenon in solid tumors that arises, in part, from uncontrolled proliferation and immature blood vessels. Previous studies have demonstrated hypoxia significantly reduced both the growth-promoting effects of estradiol (E2) and the growth-inhibitory effects of an antiestrogen on ER-positive breast cancer cell lines. A recent study comparing neoadjuvant letrozole with letrozole plus metronomic cyclophosphamide found that increased levels of HIF-1a were significantly associated with resistance to treatment. Taken together, these data indicate that hypoxia might be associated with endocrine resistance in breast cancer.

With PET/CT, radiolabeled hypoxia-avid compounds can be applied to evaluate oxygenation status in experimental or human tumors. 18F-labeled fluoromisonidazole (1-\[2-nitro- 1-imidazolyl\]-2-hydroxy-3-fluoropropane \[18F-FMISO\]) PET/CT is the most widely used one in the clinic. Studies have demonstrated an excellent correlation between the 18F-FMISO uptake and oxygenation status of several cancers including breast cancer.

The major aim of our study was to analyze uptake of 18FFMISO as well as the IHC expression of HIF-1-alpha in ER-positive breast cancers, and to predict the clinical, pathological and biological response of primary endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal female
2. With primary invasive ER positive breast cancer pathologically approved by core needle biopsy
3. The target lesion must be measurable and maximum diameter should be over 2cm.
4. Require and accept Endocrine therapy
5. Never treated with endocrine therapy before
6. Patients must have an ECOG performance status of 0 to 2
7. Leucocyte count must be ≥ 3.0\*10\^9/L and platelet count must be ≥ 40\*10\^9/L; AST/SGOT or ALT/AGPT must be \< 2 times the ULN; serum creatinine must be \< 2 times the ULN

Exclusion Criteria:

1. Patients with brain and liver metastasis
2. Previous history of severe heart dysfunction (above Class III), infection, osteoporosis, bone related event or disease in endocrine system
3. Combination of other anticancer therapy, with the exception of biphosphonate
Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

The study is conducted To evaluate the Efficacy of Doxycycline (alone and in combination with Ciprofloxacin) as an alternative to the regular regimen in treating rhinoscleroma, especially for cases with contraindication to the use of one or more of the regularly used drugs.

Rhinoscleroma is a chronic granulomatous disease endemic in many eastern countries including Egypt, Its causative agent is a gram-negative bacillus, Klebsiella rhinoscleromatis. Low socioeconomic populations are the most affected.. There are four known stages of the lesion. The first of which the 'Catarrhal stage' with purulent rhinorrhea, then there is the 'Atrophic stage' with a picture similar to that of atrophic rhinitis. The next is the 'Hypertrophic' or 'Granulomatous' stage where there are bluish red rubbery nodules in any part along the distribution of the disease, and eventually the 'Fibrotic' or 'Sclerotic' stage with stenosis deformity and loss of functions of the parts affected. Examples of commonly used drugs are 'Rifampicin' which is the most commonly used drug exhibits good results but the need for close monitoring for fear of toxicity is the only limitation to its use, Ciprofloxacin' is another Antibiotic with special efficacy as it has good tissue penetration \& produces high concentrations in respiratory tract secretions. Recently 'Doxycycline' has been approved to be used in rhinoscleroma which has the advantage of not only easier dosing but also better patient compliance as it's used for a shorter course (6 weeks) compared to most other drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included after confirmation by histopathological examination.
* Patients presented in active stages of the disease.
* Patients between 18-70 years.

Exclusion Criteria:

* Any granulomatous lesion or features suggestive of rhinoscleroma associated with any other nasal lesions like syphilis, leprosy and tuberculosis were excluded.
* Patients below 18 years and above 70 years.
* Biopsy-negative cases.
* Patients in Atrophic or Sclerotic Stages of the disease.
A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person

This study compares group diabetes education in-person versus via telemedicine

Diabetes education is important in the treatment of the person with diabetes. A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness. Unfortunately, comprehensive diabetes care is not available to all persons with diabetes. One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center. many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards. We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes. We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas. Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center. The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* age \> 18 years

Exclusion Criteria:

* Profound vision loss
* Severe hearing impairment
Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia

The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).

SGAs now is used as the main tool to treat schizophrenia, however，the mechanism of glucose and lipid metabolism disorder it brings is still unclear. Based on the previous studies, the investigators found that the CB1 gene has a close connection with the metabolism disorder.The investigators suppose that the CB1 also has a significant role in regulation of energy and metabolism in hypothalamus. In this study ,the investigators will recruit 300 Patients with schizophrenia who defined by Diagnostic and Statistical Manual-5 (DSM-5), aged 18 to 60,and all the participants will receive a 6-week systematic treatment by one of the SGAs(including olanzapine, risperidone oral solution, ziprasidone capsules), and a battery of assessments of treatment effect and safety. Plasma concentration will be tested regularly, and these genes polymorphisms of CB1 and other associated with energy metabolism will be conducted by the second generation of gene detection techniques.This study could provide evidence and data to achieve the aim of individualized medication, reduce the drugs' side effect, also throw light on the production of medication for correct the metabolism disorder.

Eligibility Criteria:
Inclusion Criteria:

* All cases must be in accordance with the DSM-5 schizophrenia or schizophreniform disorder diagnosis standards
* Negative and positive symptom scale(PANSS)score ≥ 60 points;Aged 18 to 60
* Did not participate diet or other body mass reduction projects
* Did not have physical illness which affects diet or activities
* Did not use any antipsychotic drug within 2 weeks
* Subject to consent by the Ethics Committee on clinical trials of drugs,Xijing hospital of The Fourth Military Medical University , all the participants signed a written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients with serious body disease, such as epilepsy, liver and kidney impairment, digestive system diseases, etc
* Obvious abnormalities on physical and laboratory examination
* Body mass index(BMI)≥25.0;Fasting plasma glucose(FPG)≥6.1mmol/L or/and 2-hour postprandial blood glucose(2hPG)≥7.8mmol/L or/and somebody has been diagnosed with diabetes and treatment;Fasting triglycerides≥2.2mmol/L
* Suffering from other mental disorders in line with DSM-5 diagnostic criteria
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells

Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
* AML in complete remission of refractory
* MDS RAEB-t/secondary AML
* ALL
* CML
* Non-Hodgkin Lymphoma / Hodgkin Lymphoma
* non malignant diseases (aplastic anemia, thalassemia, SCID)
* relapsed Neuroblastoma
* relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET
* soft tissue sarcoma with primary bone metastases or bone marrow
* in whom no matched donor was available,

Exclusion Criteria:

* \< 6 months after previous HSCT
* active cerebral seizure conditions
* massive progression of leukemias or solid tumours before planned trp.
* left ventricular ejection fraction \<25%
* creatinine clearance \<40ml/min before conditioning
* respiratory insufficiency with oxygen demand or DLCO \<30%
* Bilirubin \>4mg/dl, GOT/GPT \>400
* severe infection (HIV, Aspergillosis)
* pregnancy
WALANT in Distal Radius Fracture Osteosynthesis

The purpose of this study is to assess the applicability and potential benefits of Wide Awake Local Anesthesia No Tourniquet (WALANT) or Local Anesthesia No Tourniquet ("LANT) versus locoregional anesthesia (LRA) and tourniquet in osteosynthesis of distal radius fractures (DRF) during the immediate postoperative period. Our hypothesis is that being able to avoid the use of a limb tourniquet in such a procedure may cause less swelling and better surgical wound appearance in the immediate postoperative period, without compromising pain level, patient satisfaction, or improving the number of complications. In this regard, prospective randomized study was designed comparing short term results of patients who were operated using WALANT (A) to locoregional anesthesia (LRA) and tourniquet (B). Main outcomes were pain, swelling and patient satisfaction. Surgical wound bleeding,mobility, surgeon's technical difficulty, insufficient anesthesia and complications were also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who attended our hospital from December 2020th to December 2021 with DRF requiring surgical treatment who provided written informed consent and did not have any of the following excluding conditions described below

Exclusion Criteria:

1. Unsigned informed consent
2. 17 years old or younger
3. Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc
4. Open fractures
5. Polytrauma patients
6. Requiring more than a standard volar DRF approach and/or other than a volar plate.
7. DRF with \>30 days or DRF malunions Contraindications to the use of ischemia

a. Peripheral vascular disease b. Extensive soft tissue injury c. Peripheral neuropathy d. Severe infection e. Thromboembolic disease in the extremity f. Poor skin conditions g. Arteriovenous fistula h. Sickle cell hemoglobinopathy

Contraindications for proximal blocking:

1. Existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm
2. Active presence of infection at the locoregional anesthesia puncture site
3. Previous axillary lymphadenopathy
4. Previous history of local anesthetic allergy
5. Severe coagulopathy
6. Severe pre-existing neurological diseases in the upper extremity

   Contraindications for WALANT anesthetic technique
7. Documented hypersensitivity to lidocaine
8. Compromised peripheral circulation
9. Patients with previous vascular pathology, a history of vasculitis, Buerger's disease, and scleroderma
10. Patients with infection of the area surrounding the injection
Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since 10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in human samples. In addition, the curative administration of Pravastatin improves established RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the quality of life of long-term cancer survivors without interfering with prior anticancer treatment.

This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented a cutaneous and/ or subcutaneous fibrosis (grade \>= 2 according to NCI-CTCAE v4 toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients assessment will be performed at 6 and 12 months after the end of the treatment to look at a potential rebound effect.

Objective(s) of the clinical study

Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.

Second objective: To evaluate radio-induced fibrosis regression during the year following treatment stop.


Eligibility Criteria:
Inclusion Criteria:

1. Grade \>= 2 cutaneous and/or subcutaneous fibrosis (NCI-CTCAE v4 toxicities scale) revealed from 6 to 24 months after head and neck radiotherapy.
2. Head and neck cancers treated by radiation therapy +/- chemotherapy, +/- surgery, with no evidence of progressive disease.
3. Age \>= 18
4. Karnofsky PS ≥ 70
5. normal renal function (plasmatic creatinine \<= 130 micromol/l), normal cholesterol, normal hepatic function (total bilirubin \<= 1.5 UNL, SGOT and SGPT \<= 2 UNL)
6. Written informed consent of the patient.

Exclusion Criteria:

1. any chronic treatment by corticoids
2. severe cardiac pathology
3. patients already treated by statins or treated by fibrates, cyclosporine
4. history of muscular toxicities when treated by fibrates or by statins
5. Personal or familial history of hereditary muscular pathology
6. Plasmatic CPK \>3 UNL
7. patient already included in another therapeutic trial with an experimental drug,
8. pregnant patient or susceptible to pregnancy or breast feeding (patients in age to give birth must be placed under efficient contraception),
9. a social or psychological condition that does not allow a positive patient's participation in the treatment and necessary medical follow-up to be envisaged,
10. the patient is under legal restrained or tutelage.
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use.

The objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables.

The research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway.


Eligibility Criteria:
Inclusion Criteria:

* Participants must sign a informed consent form
* Must be participating in an opioid substitution program
* Must be on a steady fixed dose of medication
* Must be at least 18 years of age

Exclusion Criteria:

* Pregnancy
* Being in opioid substitution program for less than three months
Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.

Objectives:

Aim 1. The investigation will identify the specific tissue compartment distribution of immunoglobulin E (IgE) expression within human nasal polyps. Colocalization studies will examine functional interaction of IgE with effector cells.

Aim 2. The investigation will examine the direct effect of omalizumab on expression of Type 2, 1, and 3 inflammatory pathways in human nasal polyp tissue from phenotypically characterized chronic rhinosinusitis with nasal polyposis (CRSwNP) patients.

Study Rationale: Human nasal polyps express high local tissue IgE. However, the tissue distribution, cellular location and functional consequence of IgE accumulation within the polyp tissue is not known. Phase 3 studies of omalizumab demonstrated efficacy, with responders. However, the reason for non-responder outcomes in a subset of CRSwNP patients was not understood. Therefore, the goal of this study is to examine the mechanism of action of omalizumab in CRSwNP, such that specific responders for this treatment can be identified and therapy can be optimally directed.

Eligibility Criteria:
Inclusion Criteria:

* Sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell
* Confirmation of the clinical symptoms by (2a) CT scan evidence of paranasal sinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex
* Presence of nasal polyps seen on endoscopic exam or sinus CT scan
* Adults from age of 18-100 will be eligible
* All potential participants will be required to sign an Institutional Review Board (IRB) approved research consent form.

Exclusion Criteria:

* Children under the age of 18 will be excluded
* No pregnant or lactating females, prisoners, mentally disabled, or persons unable to give informed consent will be contemplated for inclusion.
* The subject groups will also exclude those with disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.
* To eliminate confounding variables in our ex vivo experimental studies, any subject with a history of exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery or any immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.