cyrilzakka/clinical-trials huggingface dataset:
Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis

The purpose of this study is to find out if supervised exercise training using a treadmill with partial weight support is safe and has an impact on gait and function of persons with Amyotrophic lateral sclerosis.

Twenty ALS patients who are independent in their transfer with assistive devise such as walker, cane, or AFO will be offered the opportunity to participate in this study. 20 subjects will be enrolled at Carolinas ALS/Neuromuscular Center at the Carolinas HealthCare System. Eligible subjects will return for 26 sessions, each lasting between 1-2 hours. At Session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and balance will be performed, which will take between 30-60 minutes. At Sessions 2-25, patients will do supported treadmill ambulation training at a very low speed 3 times a week for 6 weeks under the supervision of the physical therapist. Each session will have 30 minutes of direct ambulation with the suspension system and treadmill over a 60 minute period of time. Additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the assessments of muscle strength, spasticity, gait, and balance will be repeated. Needle EMG to assess denervation potential will be performed at base line and at the conclusion of the study. The study will last a total of 26 weeks for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Clinically probable or definite diagnosis of ALS/MND
* Able to stand independently and ambulate for six minutes with their assistive devices
* Able to complete the 25 foot walk in less than 1 minute
* Vital Capacity of over 65% predicted
* 25 to 75 years of age
* Not a pregnant woman
* Able to provide informed consent and to comply with training and assessment procedures

Exclusion Criteria:

* Unstable angina or severe left main coronary disease
* End-stage congestive heart failure
* Severe valvular heart disease
* Malignant or unstable arrhythmias
* Elevated resting blood pressure (systolic, 200mmHg; diastolic, 110mmHg)
* Large or expanding aortic aneurysm
* Known cerebral aneurysm or recent intracranial bleed
* Uncontrolled or end-stage systemic disease
* Acute retinal hemorrhage or recent ophthalmologic surgery
* Acute or unstable musculoskeletal injury
Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.

Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations.

The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome.

Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (Registry Study Inclusion Form)

Inclusion Criteria for PSMA RLT:

* sufficient tumoral PSMA expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue.
* sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets \> 75 × 109/L
* sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed invasive breast cancer, clinically stage I-II.
* Clinically lymph node negative
* Eligible for anti-endocrine treatment (per medical oncologist)
* Postmenopausal women
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Progesterone receptor negativity
* High grade tumor
* Synchronous non-breast malignancy
* Receiving any other investigational agents that could impact the efficacy of this trial regimen
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
* Uncontrolled intercurrent illness
* Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements
Study of ESBA105 Eye Drops in Healthy Subjects

Objectives:

To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers.

To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers.

ESBA105 is an anti TNF single chain antibody fragment

Eligibility Criteria:
Inclusion Criteria:

* Male or female Caucasian subjects.
* Written informed consent prior to any study procedures including screening tests for eligibility.
* Subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Normal sitting blood pressure and pulse rate, i.e.: BP: 100-160 mm Hg systolic, 50-90 mm Hg diastolic and pulse rate: 45-100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
* Bilateral corrected visual acuity of at least 0.9
* No need for regular concomitant medication.
* Ability to communicate well with the investigator and comply with the requirements of the entire study.
* Use of qualified contraception

Exclusion Criteria:

* Any evidence of infectious disease as evidenced by medical history, clinical examination, positive serology results which indicate the presence of hepatitis B and/ or C or HIV infection or positive results of the QuantiFERON TB Gold test based latent tuberculosis testing.
* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of any allergy including allergic conjunctivitis requiring acute or chronic treatment (seasonal allergic rhinitis not associated to conjunctivitis which requires no treatment may be tolerated).
* Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
* Existence of any surgical or medical condition which might interfere with the evaluation of the general drug safety and tolerability including clinically relevant ophthalmological diseases, impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, haematological abnormalities, psychiatric diseases, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
* Shallow anterior chamber, closed angle glaucoma or any other contraindication to eye dilation for ophthalmological examination.
* History or presence of any other clinically relevant (in the opinion of the Investigator) ocular disease.
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.


Eligibility Criteria:
Inclusion Criteria:

* be at least 22 years old
* have cataracts in both eyes
* have a certain degree of astigmatism in at least one eye
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires
* be available for study follow-up visits

Both eyes must qualify to be eligible to participate in the study

Exclusion Criteria:

* Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
* Have a certain disease/illness such as poorly-controlled diabetes
* Have certain ocular conditions such as uncontrolled glaucoma
* Taking medication that may affect subject vision
* Have irregular corneal astigmatism
* Pregnant, plan to become pregnant during the study, or is breastfeeding
Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.


Eligibility Criteria:
Subjects for all study groups will be male and between the ages of 25 and 65

Hypertension \& Depression Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation

Hypertension Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; no active participation in another clinical trial; no current suicidal/ homicidal ideation

Depression Group: No co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation
Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study

Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).

The general or primary objective is:

• To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.

The specific or secondary objectives are:

* To evaluate how each type of suture influences wound healing and the patient's postoperative period.
* To study bacterial colonization in each type of suture.
* To determine the tissue reaction and clinical characteristics of each suture.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
* Age: patients aged 18 years or older.
* ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Smoking patients.
Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy.

Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse.

In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 20 and 50 years
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Duration of Diabetes is between 5 and 20 years
* Men and women will be included in equal parts. A pregnancy test will be performed at screening
* Ametropia of less than 3 diopters and anisometropia of less than 1 diopter

Exclusion Criteria:

* Non insulin dependent diabetes
* Maturity onset diabetes of the young (MODY diabetes)
* Any sign of non diabetes induced vascular pathologies, systemic hypertension (defined as systolic blood pressure \> 150 mm Hg and diastolic blood pressure \> 90 mm Hg.)
* Presence of intraocular pathology other than diabetic retinopathy
* History or family history of epilepsy
* Pregnancy
Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care in third or fourth line treatment of patients with metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.
* Patient in third line or fourth line of treatment for metastatic colorectal cancer.
* Patient with measurable lesions according to RECIST criteria (version 1.1).
* Patient with ECOG equal to or less than 2.
* Patient with adequate organ function
* Other inclusion criteria may also apply

Exclusion Criteria:

* Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.
* More than 3 prior chemotherapy regimens for metastatic colorectal cancer.
* Pregnant, intent to be pregnant, or nursing female patient
* Patient with any chronic inflammatory bowel disease
* Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
* Other exclusion criteria may also apply
Lactobacillus Reuteri DSM 17938 in Functional Constipation

The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the last century in western countries. In the USA and Northern Europe, constipation is twofold the prevalence found in the East and Southern Europe. In Italy, constipation affects up to 15-17% of the whole adult population. Of them, more than half (about 10%) treats this disorder by assuming laxatives, while the remaining does not even assume drugs. A close relationship between intestinal environment and bacterial flora has been found. As a matter of fact changes in the intestinal physiology can modify the composition of bacterial flora as well as modifications in the intestinal microbiota can modify the physiology of the gut. The probiotic effects on the GI motility can be due to substances released by bacteria and/or products of their fermentation. Also, probiotic may indirectly act by the release of neuroendocrine factors and/or substances released by the immune system. Clinically, it has already been demonstrated that probiotics exert a positive effect on symptoms and intestinal habit in constipated IBS patients. In this framework, the idea to perform a long lasting intervention study in patients with functional constipation treated with probiotics sounds convincing. The present study is a randomized, double blind, placebo controlled, monocentric study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria. Clinical, physiological, hematological and immunologic variables will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilment of the Rome Criteria III for functional constipation
* Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
* Commitment to availability for the whole study period

Exclusion Criteria:

* Major abdominal surgery
* Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
* Alarming symptoms (rectal bleeding, weight loss, etc)
* Family history of peptic ulcer, colorectal cancer, or IBD
* Abnormal laboratory data or thyroid function.
Using Combine Walking and Elastic Band to Decrease Fatigue

This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. age 20 years old;
2. diagnosis of cancer;
3. can continuous wearing bracelet for 14 days or more

Exclusion Criteria:

1. Unclear and unable to answer the questionnaire；
2. Not able to walk；
3. platelet \<50,000/mm3；
4. ANC 500/cumm
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics

The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure.

Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 years old planned to undergo LAAC
* eGFR ≥ 30 mL/min per 1.73 m2

Exclusion Criteria:

* Subjects below the age of 18
* non-English speaking subjects
* eGFR \< 30 mL/min per 1.73 m2
* Subjects with history of contrast allergy
* Pregnant women