cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions

The objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures.

The main questions it aims to answer are:

Does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? Is the investigational solution safe for use in colonic lesion resection procedures?

Researchers will compare the investigational solution (Demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles.

Participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any sex, \>18 years old, diagnosed with sessile or flat polyps, with a diameter greater than or equal to 2 cm, in the intestinal submucosa by the Endoscopy Unit.
* The subject has understood and signed an informed consent form (ICF) approved by a Research Ethics Committee (REC) before any study evaluation and commits to completing the study as defined in the protocol.
* Not undergoing active treatment with antiplatelet or anticoagulant drugs.
* After signing the informed consent, patients are scheduled for lesion resection within \<3 months from their diagnosis.

Exclusion Criteria:

* Patients with documented allergy to any of the components of the mucosectomy solution or drugs used in sedation.
* Pregnant women.
* Patients on contraceptive treatment or post-menopausal.
* Hematological disorders with uncorrected coagulation abnormalities, with an INR \>= 1.5, or patients undergoing active treatment with antiplatelet or anticoagulant drugs.
* Patients with intestinal perforation or obstruction, toxic megacolon, diverticulitis, or inflammatory bowel disease.
* Patients with previous partial resection or pending resection.
* Patients with lesions classified as Paris type III and/or invasive intestinal carcinoma and/or metastases. Patients with previous treatment of the lesion (radiotherapy, endoscopic, surgical, chemotherapy).
* Patients included in another study during the previous month.
* Conditions that, in the medical judgment, contraindicate polyp removal.
* Absence of a signed informed consent, non-acceptance, or contraindication of surgical or anesthetic techniques (Patients with ASA status: High anesthetic risk (ASA score \> 3)) and difficulty in the patient's understanding of the conditions of the endoscopic procedure.
* Endoscopic appearance of invasive malignancy.
SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Identify as African American, Black, or mixed race
* Identify as someone with a substance use disorder who is not currently in treatment OR a support person of someone enrolled
* Access to a telephone for follow-up assessment
* Reside in the Memphis, TN area

Exclusion Criteria:

* Unable to understand consent procedures
Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population

The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.

Eligibility Criteria:
Inclusion Criteria:

Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009

Exclusion criteria:

Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)
Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT

This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse.

This multi-center study will include patients ages \>18 years with prolapse symptoms who have new patient consultations to Female Pelvic Medicine and Reconstructive Surgery providers.

After the new-patient consultation, patients will be contacted to see if they are interested in the study. If so, informed consent will be obtained before they complete a 1 page questionnaire that assesses their eligibility for participation.

The questionnaires are: Decisional Conflict Scale; Pelvic Floor Disorders Autonomy Preference Index; Control Preferences Scale; Pelvic Floor Distress Inventory (PFDI 20); Satisfaction with Decision Scale for Pelvic Floor Disorders; Impression questionnaire.

Patients will self-identify their zip-code on the patient impression questionnaire. This will enable a geographic analysis that will assess the relationships of neighborhood and commute on decision making.

For the purposes of this study, patients will self-identify their demographic information.

URM patients will be those who self-identify as having a non-Caucasian race and/or a Hispanic ethnicity. Providers seeing patients that are included in this study will also be consented prior to completing a 1 time demographics questionnaire. Additional clinical data will also be obtained.

Patients will be able to utilize interpreters to participate. Information regarding the use of interpreters will be collected. Questionnaires that are available in, and validated in, non-English languages will be used as appropriate.

The lead study site is Women \& Infants Hospital/ Brown University, with additional study sites planning to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Provider inclusion criteria consists of FPMRS providers at study sites seeing new patients with symptoms of pelvic organ prolapse. Patient inclusion criteria consists of new patients 18 years or older with symptoms of pelvic organ prolapse.

Exclusion Criteria:

* Provider exclusion criteria consists of providers who decline participation. Patient exclusion criteria consists of patients who decline participation, and those who cannot complete the study interventions with the assistance of an interpreter.
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI

The investigators plan to study inflammation in the brain (neuroinflammation) in human patients with epilepsy using a novel, non-invasive technique that has been proven successful in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug with minimal side effects that is FDA-approved for the treatment of iron deficiency anemia, as the contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy patients who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for curative brain surgery. During the hospital stay and after informed consent, the patient will receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of MRI at 24-48 hours after the injection. The patient will also undergo a separate "baseline" MRI session (if not already done at DHMC) at admission or at more than four weeks after the injection but before any brain surgery. Brain regions that preferentially uptake ferumoxytol are localized by subtracting the post-injection MRI session from the "baseline" MRI session. The investigators will investigate whether these regions overlap with the epileptogenic focus, namely the region that generates epilepsy and is localized by video-EEG and other diagnostic measures. Lastly, for those patient participants who thereafter undergo brain surgery, DHMC neuropathologists will use special stains to detect and quantify neuroinflammation in brain tissue removed, and the results will serve as the reference for the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in detecting neuroinflammation.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a plan of hospital stay at Dartmouth-Hitchcock Medical Center for video-EEG monitoring for standard presurgical evaluation for epilepsy.
* Between the ages of 18 and 70 years old.
* Patient or patient's legal guardian is able and willing to sign the informed consent prior to the ferumoxytol injection.
* Able to undergo routine MRI.

Exclusion Criteria:

* Absence of epileptic seizure event that is detected by video-EEG monitoring and/or by a board-certified epileptologist during the hospital stay
* History of central nervous system conditions other than seizure, including but not limited to history of brain surgeries, cerebral vascular accidents, encephalitis or meningitis, or diagnosis of brain tumors, cerebral aneurysms, multiple sclerosis or Alzheimer's disease.
* History of medical conditions that may influence iron metabolism, including but not limited to diagnosis of hemochromatosis, hyperbilirubinemia, hepatitis, cirrhosis or liver tumors, physical exam finding of jaundice or hepatomegaly, history of abnormal liver function test (LFT) results, or significant family history of hemochromatosis.
* Medical history of adverse reaction to ferumoxytol
* Pregnant or breast feeding
Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation

The purpose of this study is to study if a patients follows an exercise program specifically designed for them during the time of their treatment after surgery. Their ability to follow the program and its influence on their weight maintenance and early post-operative lymphedema rates will also be studied. Lymphedema is a condition in which excess fluid collects in tissue and causes swelling of the arm(s).


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they have any of the following surgical procedures performed by an attending on the Breast Service:

SLNB alone Axillary lymph node dissection (ALND) alone Total Mastectomy TM (+/- reconstruction) with SLNB or ALND Breast conserving therapy (BCT) with SLNB or ALND

* Age \> 18 years
* Planned to undergo adjuvant post-operative chemotherapy with or without radiation at MSKCC and have not yet started chemotherapy

Exclusion Criteria:

* Undergoing TM or BCT without SLNB
* Having had prior breast cancer treated with surgery
* Unable to participate in a exercise program related to other medical problems
* More than 8 weeks post surgery.
* Having a concurrent cancer in addition to breast cancer
* Who have had any type of chemotherapy in the past two years
Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years and ≤ 75 years
2. Has a histologically confrmed diagnosis of malignant melanoma
3. Previously received failed first-line treatment for melanoma
4. Patients may have a history of liver metastases, but the metastases should be less than 3
5. Patients with treatment-asymptomatic brain metastases may be included, must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and free of steroid medication for at least 4 weeks
6. Those with at least 1 measurable lesion (RECIST version 1.1)
7. ECOG 0-1
8. Non-lactating patients
9. Good organ function

Exclusion Criteria:

1. Previous (within 5 years) or concurrent other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence \> 3 years after radical resection
2. Has an active or potentially recurrent autoimmune disease
3. History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
4. Known presence of active tuberculosis TB
5. Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
6. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study
7. Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse
Efficacyof Pilates Exercises in Lowback Pain

OBJECTIVE: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with home based exercise.

MATERIAL AND METHODS: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

Eligibility Criteria:
Inclusion Criteria:

* chronic non-specific low back pain for \>3 months,
* visual analog scale (VAS) score of 3-6
* female patients aged 18-60 years,
* body mass index (BMI) within normal limits (18.5-24.9 kg/m²)
* ability to continue the program.

Exclusion Criteria:

* Malignancies,
* infections
* inflammatory diseases
* severe osteoporosis,
* arthritis
* metabolic bone diseases
* pregnancy
* cardiovascular diseases that limit effort capacity
* other musculoskeletal conditions that may impede attaining positions required in exercises
* a history of spinal surgery
* cognitive impairment.
Sotrovimab Expanded Access Treatment Protocol (COVID-19)

An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the investigator, meets the current Emergency Use Authorization (EUA) eligibility criteria for sotrovimab

OR

* patients currently hospitalized for a non-COVID-19 illness who acquire COVID-19 (nosocomial infection) and otherwise meets all the current EUA eligibility criteria

Exclusion Criteria:

* Hospitalized due to COVID-19 (excludes nosocomial infection)
* Require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19
Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

* SCI ASIA: A, B, C,D
* Between 20 and 70 year of age
* \>1 year post SCI
* Complete or incomplete spinal cord injury.
* Expected will undergo spinal cord stimulation surgery.
* Continued rehabilitation after surgery for spinal cord injury.
* Able to comply with procedures and follow up.
* Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities

Exclusion Criteria:

* Have significant cognitive impairment (MMSE\<24).
* Had a mental illness within one year or been treated in the past.
* Have Major depressive disorder.
* Active cancer diagnosis.
* Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
* Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
* Unable to read and/or comprehend the consent form.
* Have concerns about this trial and do not sign consent.
A Study for Patients With Secondary Progressive Multiple Sclerosis

The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis.

Dirucotide is generic name for MBP8298.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of SPMS
* Absence of relapse in the 3mos prior to baseline
* EDSS of 3.5 - 6.5
* Pyramidal or Cerebellar FSS greater than or equal to 3
* A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive.
* Informed consent
* Subject reliability and compliance

Exclusion Criteria:

* Diagnosis of Primary Progressive MS
* Subjects have previously received MBP8298
* Recent history of malignancy, with the exclusion on basal cell carcinoma.
* Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment
* Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
* Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period.
* History of anaphylactic/anaphlactoid reactions to glatiramer acetate
* Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant
* Known allergy to Gadolinium-DTPA
* Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment
* Treatment at any time wtih an altered peptide ligand
* Any conditions that could interfere with the performance of study specific procedures e.g.MRI
* Previous randomization to this study
* Known positivity for HIV, Hepatitis B, or Hepatitis C
* Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos.
* Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly
* Known or suspected current or past alcohol or drug abuse (within the last year)
* Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements
* Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study