cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.

This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the study AFO.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a primary diagnosis of multiple sclerosis
* Individuals \>21 and \<60 years old
* Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
* Current or past history of single or bilateral AFO use, including neuroprostheses
* Evidence of weakness in plantarflexors

Exclusion Criteria:

* The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
* Individuals with BMI with \>/= 35kg/m2
* Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
* Individuals that will begin the use of Ampyra during the course of the study
* Individuals for whom the cost of an orthosis would represent a financial burden
* Individuals who are receiving concurrent physical therapy services elsewhere,
* Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of \>22
* Individuals for whom bilateral AFOs are indicated, but have different design
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)


Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic operable Stage II-III breast cancer
* Histologically documented TNBC (Triple Negative Breast Cancer)
* Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
* Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
* No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
* Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Exclusion Criteria

* Prior history of invasive breast cancer
* For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
* Previous therapy with anthracyclines or taxanes for any malignancy
* Cardiopulmonary dysfunction
* Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Urinary outflow obstruction
* Active tuberculosis
* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
* Prior allogeneic stem cell or solid organ transplant
* Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma

Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -

Exclusion Criteria:

Pregnancy HIV + Refuse treatment

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Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects

Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.

Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.


Eligibility Criteria:
Inclusion Criteria:

Patients with dry eye syndrome (DES):

* Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
* normal findings in the ophthalmic examination other than DES

Healthy control group:

* Men and Women aged between 45 and 80 years,
* normal findings in the medical history and ophthalmic examination

Exclusion Criteria:

* Abuse of drugs or alcoholic beverages
* Participation in a clinical trial
* Symptoms of a clinically relevant illness
Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the criteria listed to be enrolled in the study.

  1. They are 18-45 years of age (inclusive).
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research while enrolled on this study.
  5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
  6. They agree to wear their lenses for at least 12-14 hours per day.
  7. They own a wearable pair of spectacles (by self-report).
  8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
  9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
  10. They have best corrected distance visual acuity of at least 0.20 binocularly

      Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. They have an ocular disorder which would normally contraindicate contact lens wear.
  2. They have a systemic disorder which would normally contraindicate contact lens wear.
  3. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
  4. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
  5. They have had cataract surgery.
  6. They have had corneal refractive surgery.
  7. They are pregnant or breast-feeding.
  8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
  9. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
  10. They have taken part in any other clinical trial or research within two weeks prior to starting this study.
  11. History of allergy to sodium fluorescein or lissamine green.
  12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
  13. They any slit lamp findings of Efron Grade 3 or greater (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of \< Grade 3 which in the investigator's opinion would contraindicate contact lens wear.
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.

Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.

In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.

There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory breast cancer
* Clinical complete response after neoadjuvant chemiotherapy
* Targeted tumor
* Written informed consent

Exclusion Criteria:

* Metastasis
* Progression disease
* Recurrent disease
* Contraindications to adjuvant radiation therapy
Movement Visualization in Patients With Hemophilic Arthropathy

Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.

Objective. Assess the safety and efficacy of an intervention in pain through visualization of the movement using a mobile application of augmented reality and immersive 360º video, regarding the frequency of bleeding and the improvement of pain perception and quality of life, joint state , strength and functionality in patients with hemophilic arthropathy.

Study design. Randomized, multicenter, simple blind clinical study.

Method. 140 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a 6-month follow-up period.

Expected results. Observe the effectiveness of movement visualization in the characteristics of pain, and its implication in functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Medical diagnosis of hemophilic arthropathy
* Chronic joint pain
* Over 18 years
* On prophylactic treatment or on demand with FVIII / FIX concentrates

Exclusion Criteria:

* Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
* Painless patients
* Amputee, epileptic or seriously impaired vision patients
* Patients receiving physiotherapy treatment at the time of the study
* Patients who have not signed the informed consent document.
Factors Affecting Treatment Expectations in Chronic Neck Pain

The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-80 years of both sexes diagnosed with chronic neck pain by a physical medicine and rehabilitation specialist will be included in the study. Volunteers who sign the consent form following verbal information will be included in the study.

Exclusion Criteria:

* The presence of instability in the neck joints, trauma within the last year, severe osteoporosis, previous neck surgery, physical therapy within the last 6 months, neurological findings or radiculopathy.
Effects of the Consumption of a Supplement Rich in Docosahexaenoic Acid (DHA) From Algae

Vegetarian diets are increasing worldwide. To prevent nutritional deficiencies, supplementation with nutrients that are only present in animal food can be needed. In relation to fatty acids, vegetarian diets involve low intake of omega-3 polyunsaturated fatty acids (n-3 PUFA) and low blood levels of the long-chain n-3 derivatives, whose main dietary sources are fish and shellfish, particularly the levels of docosahexaenoic acid (DHA), which has important health benefits, are low.

In this regard, validation of supplements rich in the n-3 fatty acid DHA that are not obtained from fish is needed, thus the study will test the bioavailability and metabolic effects of a DHA supplement form algae.

The study will be conducted on the effects of the DHA supplement versus placebo in vegetarian and non-vegetarian healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥18 and ≤45 years).
* Healthy.
* Women.
* Men.
* Participant following either a vegetarian diet during at least 6 months or following a omnivorous diet but consuming fish 2 times per week or less.

Exclusion Criteria:

* Age \<18 and \>45 years old.
* Pregnancy.
* Diseases: liver diseases, gastric diseases, irritable bowel, hypercholesterolemia, hypertension, diabetes, biliary colic.
* Having participated in a clinical study in the last 3 months.
* Eating disorders.
* Consumption of foods fortified with omega-3 fatty acids in the last 3 months.
* Consumption of supplements of omega-3 fatty acids in the last 3 months.
* Participant who have followed either a vegetarian diet for less than six months or an omnivorous diet including fish more than 2 times per week.
Integrated Eating Aversion Treatment Manual-Parent Version

The purpose of this study is to further develop the integrated Eating Aversion Treatment (iEAT) manual, which is designed to address chronic food aversion in children with chronic food refusal. This study will evaluate the feasibility and efficacy of the iEAT manual when it is used in the home home environment with caregivers.

The purpose of the current study is to further develop the integrated Eating Aversion Treatment (iEAT) manual and address the unmet needs of many children with chronic food refusal by providing a technology-based treatment that makes it easy for parents to understand how to duplicate the models of institutional care. The study seeks to expand upon this treatment by introducing the manual and procedures in an electronic form to be implemented by caregivers in a home environment.

The study team aims to enroll 20 participants with chronic food refusal and formula or feeding tube dependence. Participants will be randomly assigned to receive the iEAT manual intervention with the technology supported manual or a control group (10 participants per group). The intervention with the iEAT manual will involve 10 biweekly outpatient appointments of about 45 minutes in length. Target behaviors will be assessed during each treatment meal. Participants will be assessed pre-treatment and at a one month follow-up to assess long term effects. Parents in the control group will provide a food diary once a month, for 5 months. Those assigned to the control group will be able to cross-over to receive the iEAT treatment manual following completion of post-study measures. Screening, collecting data for outcomes measures, and the intervention will be conducted at the each participant's home. Data will be collected on parent compliance with the treatment manual and child food acceptance, nutritional intake, and refusal behaviors.

Eligibility Criteria:
Inclusion Criteria, for the child:

* The child demonstrates failure to meet appropriate nutritional and/or energy needs based on Diagnostic and Statistical Manual (DSM)-V criteria (American Psychiatric Association, 2013) for Avoidant/Restrictive Food Intake Disorder
* Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings
* Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern

Inclusion Criteria, for the parent/caretaker:

* Must be English literate
* Must have access to an iPad or a computer

Exclusion Criteria, for the child:

* Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician
* Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction)

Exclusion Criteria, for the parent/caretaker:

* Caregivers do not commit to implementing the structured feeding protocol at least 2 times daily
Screen to Save: A Colorectal Cancer Educational Intervention

The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 50-74 years old
* Attendee at event where educational module is offered
Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial

This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection.

The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.

The primary aims of this study are:

AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875 mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in comparison to a placebo control supplement.

AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and newborn clinical parameters.

AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory pathways, Th1/Th2 cytokine secretion, and bactericidal properties.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to \<35 years.
* Current residence in Dhaka at a fixed address
* Plans to have the delivery performed at the Shimantik maternity center, and to stay in Dhaka throughout the pregnancy and for at least one month past the date of delivery.
* Gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period (LMP).

Exclusion Criteria:

* Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month prior to enrolment, or refusal to stop taking supplemental vitamin D at any dose after enrollment.
* Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
* Severe anemia (hemoglobin concentration \< 70 g/L).
* Complicated medical or obstetric history that may increase the risk of preterm birth or labor/delivery complications, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, preterm labor, or multiple gestation).
* Prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life).