cyrilzakka/clinical-trials huggingface dataset:
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke

To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.

* we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
* we also assess the safety of A2NTX and compare it to that of BOTOX.


Eligibility Criteria:
Inclusion Criteria:

* patients with lower limb spasticity after stroke
* duration more than 6 months
* Modified Ashworth Scale of ankle joint more than 2

Exclusion Criteria:

* patients with previous botulinum toxin injections to lower limbs
* patients with serious hepatic, renal or cardiac dysfunction
* patients with respiratory failure
* patients who cannot understand the instructions
Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

This comparative effectiveness and descriptive retrospective cohort study includes commercially insured adults enrolled in one of four health plans participating in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network. The investigators included patients who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy. The investigators will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. The investigators will follow patients from first G-CSF exposure until up to six cycles of chemotherapy receipt, death, or insurance disenrollment. The primary effectiveness outcome is incidence of febrile neutropenia. Secondary outcomes include incidence of adverse events and trends in product use over time. The investigators will compare febrile neutropenia incidence between originator and biosimilar products using inverse probability weighting to control for confounding. Secondary analyses will examine 'as treated' outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 20 or older
* Diagnosis of lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancer
* Beginning intermediate or high neutropenia risk chemotherapy

Exclusion Criteria:

* One inpatient or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancer different from enrolling cancer diagnosis
* Any of the following in 183 days prior to Index Date:
* Any chemotherapy or G-CSF product receipt
* 2\< medical claims at least 30 days apart for a skilled nursing facility or hospice care
* 2\< diagnoses/procedure codes at least 1 day apart for cancer-related radiotherapy, bone marrow or stem cell transplant, diagnosis of HIV/AIDS, severe hepatic disease, chronic kidney disease, or any non-oncology related neutropenia
SGM-101 in Colorectal Lung Metastases

Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer.

This study aims to prove feasibility for colorectal lung metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with lung metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;
2. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
3. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
4. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
6. Previous SGM-101 use
Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion


Eligibility Criteria:
Inclusion Criteria:

* Macular edema persisting for more than 3 months period despite conventional medication.
* Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
* Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
* Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
* Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).

Exclusion Criteria:

* Diabetes mellitus
* Additional vitreoretinal diseases
* History of pars plana vitrectomy
* Previous macular grid laser treatment
* Intravitreal triamcinolone acetonid treatment
* Complicated cataract surgery
* Advanced glaucomatous damage of optic nerve head
* Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
* Age-related macular degeneration
* Pregnancy and lactation
* Women in childbearing potential who are not using double safe contraception
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored.

Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer diagnosis (any stage)
* Age ≥ 18 years
* Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
* Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
* Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
* Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist
* Ability to read, write and understand English
* Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study

Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study):

* Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)

Exclusion Criteria:

* Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
* Current pregnancy

Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):

* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.
Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study)

The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not treated with recombinant Growth Hormone or IGF-1


Eligibility Criteria:
Inclusion Criteria:

* Short children, height ≤ -2.5 SDS
* Age ≥ 2 years
* With at least one normal or elevated peak GH response to a stimulatory test (peak GH ≥ 7 ng/mL) at the time of the study and/or at a given time-point during the last 12 months
* Pre-pubertal
* Signed Informed Consent, including agreement to have blood samples taken for hormonal measurement and genetic analysis, by both parents or by Legally Acceptable Representatives when applicable and the child when applicable

Exclusion Criteria:

* The following identified causes of short stature:
* GH-deficient short stature
* Other endocrine causes (hypothyroidism, Cushing's syndrome, parathyroid or vitamin D disorders, hypogonadism)
* Identified syndromes with genetic abnormalities (including Turner, Noonan and Russell-Silver syndromes)
* Chronic diseases including malnutrition, coeliac disease, chronic inflammation, muscular dystrophy, thalassaemia, blood disorders, severe liver or kidney disease and severe cyanotic heart disease
* Chronic diseases requiring treatment with chronically administered corticosteroids
* Skeletal dysplasia
* Psychosocial short stature
* Patients having received irradiation, including total body irradiation
* Patients currently on GH or IGF-1 therapy or having received GH or IGF-1 therapy in the last 12 months
* Patients likely to require GH, IGF-1 or chronic corticosteroid treatment during the study
* Any mental condition that prevents both parents or Legally Acceptable Representatives and the child when applicable from understanding the nature, scope and possible consequences of the study, or any evidence of an uncooperative attitude
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=16 years of age;
* current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
* naive to use of the B2000 device;
* positive test results for human immunodeficiency virus infection.

Exclusion Criteria:

* patients naive to Fuzeon;
* inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
* evidence of active, untreated, opportunistic infections.
Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)

Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY)

This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. No drug treatment will be administered.

Eligibility Criteria:
Inclusion Criteria:

1. Male 18 years of age or older
2. At least 6 months post radical prostatectomy for localized prostate cancer
3. Cystoscopic evaluation of the lower urinary tract within 12 months of screening
4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
5. Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
6. Post-surgical Prostate Specific Antigen (PSA) \<0.04

Exclusion Criteria:

1. Inability to insert the Comfort Plug™ into his own urethra and remove it
2. History of significant incontinence prior to radical prostatectomy
3. Evidence of incomplete bladder emptying post radical prostatectomy
4. Recurrent , refractory bacteruria
5. Urethral stricture disease.
6. History of meatal stenosis or phimosis
7. History of any other malignancy except basal cell skin cancer
8. Planned radiotherapy for post prostatectomy residual disease within the next 90 days
9. Evidence of neurogenic bladder dysfunction
10. Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome
11. Ongoing constipation
12. Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA)
13. Hemophilia
14. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve
15. Currently receiving successful medical treatment for incontinence.
16. The usage of male urethral slings
17. Planning to travel by airplane during the course of the study
Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in breast cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Gastrin-releasing peptide receptor (GRPR) is a member of the G protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of GRPR. On the other hand, the RGD moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
* To provide basic information and sign the written informed consent.

Exclusion Criteria:

* Consisted of conditions of mental illness;
* Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
* Severe allergy or hypersensitivity to IV radiographic contrast
* Claustrophobia to accept the PET/CT scanning
* Pregnancy or breast feeding
Validating Machine -Learned Classifiers of Sedentary Behavior and Physical Activity

The majority of the US population spends most of the day sitting and the we have new scientific evidence that this can contribute to poor health regardless of how much physical activity a person does. However, we do not measure sitting time very accurately and when we ask people to tell us how much they do, their answers are unreliable. Our study will use small sensors to objectively measure when people sit or do physical activity, and we will use sophisticated computational techniques to summarize these movement patterns.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for participants 6-17 yr olds:

* provide written parental consent to complete study protocols;
* provide verbal assent to complete study protocols;
* willingness to complete 2 visits to UCSD offices;
* willingness to wear multiple sensor devices on 7 days for 12 hours per day;
* willingness to wear wrist accelerometer on 7 days for 24 hours per day;
* willingness to have their height and weight measured;
* be able to walk unassisted
* able to read and understand study materials in English.

Inclusion Criteria for participants 18-64 yr old:

* provide written consent to complete study protocols;
* willingness to complete 2 visits to UCSD offices;
* willingness to wear multiple sensor devices on 7 days for 12 hours per day;
* willingness to wear wrist accelerometer on 7 days for 24 hours per day;
* complete a survey assessing their demographic characteristics;
* willingness to have their height and weight measured;
* be physically and cognitively able to walk unassisted,
* able to read and understand study materials in English.

Inclusion Criteria for participants 65-85 yr olds:

* provide written consent to complete study protocols;
* correctly answer verbal questions about their comprehension of the informed consent;
* willingness to complete 2 visits to UCSD offices;
* willingness to wear multiple sensor devices on 7 days for 12 hours per day;
* willingness to wear wrist accelerometer on 7 days for 24 hours per day;
* complete a survey assessing their demographic;
* willingness to have their height and weight measured;
* be physically and cognitively able to walk without the assistance of another person (walking aids are permitted)
* able to read and understand study materials in English.

Exclusion Criteria:

* unable to ambulate;
* attends a workplace or school on monitoring days that prohibits static images being taken by a SenseCam worn around the neck of the participant;
* pregnancy in second or third trimester.
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

Eligibility Criteria:
Inclusion Criteria:

* cardiac patient volunteers (5 male and 5 female)

Exclusion Criteria:

* skin rash or infection over the sternum
* Sternal incision within 3 months from the date of enrollment
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients

Both in Mexico and in the world, breast cancer is the most common malignancy in women. It is estimated that in 2020, 28.2% of the new cancer cases reported in our country correspond to breast cancer, which translates to 30,000 new cases. In addition, it is relevant to mention that approximately 12% of Mexican patients are diagnosed with stage IV breast cancer and it is estimated that 20-30% of women with early stage cancer will have a distant recurrence of the disease. Thus, about 40% of patients will find themselves in a metastatic stage at some point in their breast cancer journey.

Various studies, including Mexico, report that only half of patients with metastatic breast cancer are aware that their disease is not curable, 31% say they are not sure, and 17% think it is curable. Likewise, 58% considered that they did not have enough knowledge to actively participate in conversations about their therapeutic options, which means that 40% reported difficulty talking about treatments with their doctors. This has shown that there are suboptimal levels of knowledge information on curability, treatment objectives and prognosis of their condition in patients with metastatic breast cancer. This lack of understanding is alarming given that a general understanding of the disease is crucial for informed decision making and adherence to cancer treatment.

Due to these alarming results, we seek to recruit women ≥18 years of age who are candidates to start first- or second-line treatment for de novo or recurrent metastatic breast cancer from various hospital centers in the country with public and private coverage, including Hospital Zambrano Hellion TecSalud as coordinating center in Nuevo León. The objective will be to evaluate whether a systematized communication model for patients with metastatic breast cancer allows increasing knowledge about the non-curative nature of treatment, compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of de novo or recurrent metastatic breast cancer
* Candidate to start the first or second line of treatment for metastatic breast cancer

Exclusion Criteria:

* Receipt of a line of treatment for metastatic breast cancer posterior to the second line