cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Treadmill Training in Establishing Walking After Stroke

Being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. For the family, the loss of the stroke sufferer from everyday life is a catastrophic event. For the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. Therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance.

This trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.

Only half of the stroke patients unable to walk who are admitted to inpatient rehabilitation in Australia learn to walk again. Treadmill training with partial weight support is a relatively new intervention that is designed to train walking. However, a Cochrane Systematic Review (Moseley et al 2003) concludes that there is as yet no definitive answer about whether this intervention helps more non-ambulatory patients learn to walk compared to assisted overground walking.

Participants will be 130 stroke patients who are unable to walk independently early after stroke. They will be recruited and randomly allocated to a control group or an experimental group.

The control group will undertake routine assisted overground walking training while the experimental group will undertake treadmill walking with partial weight support via an overhead harness. Duration and frequency of intervention and the amount of assistance from therapists will be standardised across groups.

Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Within 28 days post stroke
* Aged between 50 and 85 years of age
* Unilateral hemiplegia/hemiparesis and
* Score for Item 5 of the Motor Assessment Scale for Stroke \< 2

Exclusion Criteria:

* Any barriers to taking part in a physical rehabilitation program
* Insufficient cognition/language
* Unstable cardiac status
* Neuro-surgery
* Any pre-morbid history of orthopaedic conditions or any other problems that would preclude patient from relearning to walk.
Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)

The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins
* Optimal medical treatment
* High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair
* NYHA class of at least II
* Written informed consent

Exclusion Criteria:

* VCI diameter \> 32 mm
* Severe left ventricular dysfunction with LVEF \< 30%
* Severe mitral insufficiency
* Estimated life expectancy \< 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
* Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
* Evidence of stroke / TIA during the last 180 days
* Leukopenia (WBC \< 3000 cell/mL), anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt \< 50,000 cells/mL), or any known blood clotting disorder
* Evidence of an intracardiac mass, thrombus or vegetation
* Active upper GI bleeding within 1 month (30 days) prior to procedure
* Patients with an acute emergency
* Contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure
* Allergy against the use of implanted stent / prosthesis
* Patient undergoing regular dialysis or a serum creatinine above 3.0 mg/dl
* Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
* Active bacterial endocarditis within 6 months (180 days) of procedure.
* Women of childbearing potential without highly effective contraception (PEARL-Index \< 1%)
* Inability to comply with all of the study procedures and follow-up visits
* Subjects who are legally detained in an official institute (according to § 20 MPG)
Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation

The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.

The aim of the study is to develop a modified release oral tablet formulation that maintains plasma concentrations within the target therapeutic range, and is safe and tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males \& females
* Aged 18 to 65 years
* Body mass index of 18.0 to 35.0 kg/m2
* CYP2D6 (intermediate or extensive metabolizer)

Exclusion Criteria:

* Subjects with a resting heart rate (HR) \>90 bpm, and/or systolic blood pressure (BP) \>150 mmHg, and/or diastolic BP \>90 mmHg
* Subjects with QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 ms (males) or \>470 ms (females)
* Personal or family history of long QT syndrome or sudden death
* Subjects who are CYP2D6 (poor or ultra-rapid metabolizer)
Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues

The purpose of this study is to better define the potential molecular and anti-inflammatory changes induced by the modified Atkins diet in the brains of patients with treatment resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20 subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects in this study to compare serologic and brain tissue specimens. Approximately five (5) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5) subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue specimens will be obtained at the time of surgery and will be compared. The goal of this study is to identify whether or not there are changes in neuroinflammation or neuroexcitability in the human brain induced by the modified Atkins diet.


Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas Medical Center will be eligible for enrollment.

* Patient is at least 18 years of age
* Patient is willing to participate by complying with the modified Atkins diet 3 - 4 weeks prior to surgery and maintain a thorough food diary (Intervention study group) or to continue their usual diet and maintain a thorough food diary (Nonintervention study group)
* Patient/ his/her parent, caregiver, or health care proxy is willing and able to provide consent or assent

Exclusion Criteria:

* Patients under the age of 18 will be excluded
* Patients in whom a two-stage surgery is planned without any resection of brain tissue during the initial craniotomy
* Patients unwilling to comply with modified Atkins diet 3 -4 weeks prior to surgery or unwilling to maintain a thorough food diary will be excluded.
* Patients who are currently on an Atkins or Low Glycemic Index Diet will not be eligible for inclusion in the nonintervention group.
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
* Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
* Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.

Exclusion Criteria:

* Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior to their first dose of study drug.
* Participant has known leptomeningeal metastases.
* Participant has received more than one prior systemic therapy regimen for SCLC.
* Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
* Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
* Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake

The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged between 18 and 65 years (inclusive)
2. Body Mass Index (BMI) is 27.0 to 45.0 kg/m2, inclusive
3. Able to give signed informed consent
4. Ambulatory and able to perform exercise program (Arena Healthy Lifestyle Program, see Appendix 1)
5. Eligible male and female patients must agree not to participate in a conception process
6. Considered to be in stable health in the opinion of the Investigator

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
3. Clinically significant new illness in the 1 month before screening
4. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
5. Recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. SSRI's, SNRI's, and other medications must meet washout requirements.
6. Significant dislike or allergy to foods used during the food intake tests
7. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 3 months of screening; cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening
   * Unstable angina
   * History of congestive heart failure caused by insufficiency, damage, or stenosis of any heart valve
   * History of pulmonary artery hypertension
8. Positive result of HIV, hepatitis B or hepatitis C screens
9. Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat)
10. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Action Observation Training With 3D Virtual Reality in Patients With Multiple Sclerosis

Multiple sclerosis is a chronic, autoimmune and inflammatory disease of the Central Nervous System characterized by neuronal demyelination and axonal degeneration. Upper extremity problems are present in MS patients from an early stage, affecting the performance of the individual and leading to a decrease in activity of daily living ability in proportion to the extent of the problem. Action Observation Training is currently being examined as one of the methods used for the improvement of motor disorders and has been shown in the literature to be effective on different functions in neurological diseases.

The aim of this study was to investigate the effects of action observation training with 3D virtual reality on upper extremity functions, fatigue, cognitive functions, activities of daily living and quality of life in MS patients.

Hypothesis 1: Action observation training with 3D virtual reality has an effect on upper extremity functions in MS patients.

Hypothesis 2: Action observation training with 3D virtual reality has an effect on cognitive function in MS patients.

Hypothesis 3: Action observation training with 3D virtual reality has an effect on fatigue in MS patients.

Hypothesis 4: Action observation training with 3D virtual reality has an effect on activities of daily living in MS patients.

Hypothesis 5: Action observation training with 3D virtual reality has an effect on quality of life in MS patients.

The training will involve watching 3D videos of upper limb functions in VR and then repeating the functions by the participants. The AOT group will watch video sequences involving upper limb functions, while the control group will watch landscape videos that are not likely to elicit activity in motor or ANS areas.

In our study, 3D videos of upper limb functions will be recorded with a 360° camera and will be shown to individuals through the VR system from the primary person's perspective.

Eligibility Criteria:
Inclusion Criteria:

* \< 2 years MS diagnosis according to McDonald criteria
* between 3.5 and 6 the EDSS
* Nine Hole Peg Test \> 30s for at least one upper extremity
* no change in medication in the last 6 months
* having MS disease with ongoing attacks
* \>2 Modified Ashworth Scale in the upper extremities
* MOCA\>25

Exclusion Criteria:

* diagnosed with neurological (except MS), cardiopulmonary, metabolic or musculoskeletal disease that would prevent treatment and evaluation
* receiving botulinum toxin treatment in the last 6 months
* visual impairment uncorrected by optical devices
* inability to adapt to treatment based on 3D immersive virtual reality (e.g. with cognitive impairment, communication problems, psychological problems or vestibular system problems)
Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

This study aim to describe the presence, type and size of Corona mortis (CMOR) in patients undergoing total extraperitoneal (TEP) inguinal hernia repair procedures. This study also aim to describe the preperitoneal vascular anatomy of inguinal area and provide in vivo knowledge about CMOR.

Corona mortis is classically defined as the arterial and/or venous vascular anastomosis between the obturator artery and external iliac artery (most commonly the inferior epigastric artery) that crosses the posterior aspect of the superior ramus of the symphysis pubis. It runs along the posterior aspect of the superior pubic ramus and its laceration can prove life threatening in trauma cases or in scheduled operations.

CMOR is clinically important due to the potential risk of bleeding in pelvic fractures, pelvic and acetabular operations, surgery for urinary incontinence, oncologycal pelvic dissections and laparoscopic hernia repair. It requires special interests from different surgical branches, such as orthopedics, oncologic surgery, urogynecology and general surgery. Vascular anatomy of retropubic area, especially CMOR, should be kept in mind by surgeons performing laparoscopic surgery for hernia repair. In literature, the anatomical data have usually been come from studies performed on cadavers. The aim of this study was to provide in vivo knowledge about the presence, type (venous and/or arterial) and size of CMOR in patients who underwent TEP repair.

300 patients will undergo TEP procedure for unilateral or bilateral inguinal hernias. TEP procedures will be performed with three ports and one or three skin incisions. The presence and type of CMOR will be evaluated, and picture will be made. The size of the CMOR will be defined with ruler inserted true the 10 mm port.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed primary or recurrence unilateral or bilateral inguinal hernia
* Age between 18 and 90;

Exclusion Criteria:

* Patients who prefer other surgical approach than TEP
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma

Stress and anxiety can negatively affect children with asthma. Reducing the stress of asthmatic children and their families may lead to improved asthma care and fewer asthma symptoms in the children. The purpose of this study is to develop and evaluate a family-focused asthma education program aimed at reducing stress levels and improving asthma care for urban children with asthma.

Asthma is a serious, chronic illness that affects 9 million children in the United States. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. Asthma attacks can be triggered by a variety of irritants, including mold, pollen, tobacco smoke, or allergies. Stress can also cause asthma attacks, and children who experience high levels of stress and anxiety tend to have poor asthma management skills and health outcomes. Additionally, family stress can affect the ability of families and caregivers to provide adequate care to children with asthma. Currently, few asthma education programs are aimed at helping both children and parents manage stress. The purpose of this study is to evaluate the effectiveness of a stress-reduction family intervention on improving health outcomes in asthmatic children.

Study researchers will first conduct focus groups with children who have asthma, their parents, and community health organizations to identify barriers to effective asthma management and sources of stress for caregivers; a family-focused intervention will then be developed. Fifty families with an asthmatic child will be enrolled and randomly assigned to one of two groups. Group 1 participants will partake in four to six home-based, family educational sessions over a 4-month period. Sessions will focus on asthma education and stress management techniques for the entire family. One of these sessions may take place at the child's doctor's office as a way to focus on improving parent-doctor communication. Group 2 participants will partake in a single home-based asthma education session. Study visits for all participants will occur at baseline, Month 4, and 6 months post-intervention. At these timepoints, asthma self-management will be assessed through family interviews and observation of the child's inhaler use; tobacco exposure levels will be measured with a urine test; and family functioning and stress levels will be assessed with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of persistent asthma
* Poorly controlled asthma, as determined by emergency department visit, hospitalization, or steroid burst in the year prior to study entry
* Primary caregiver is under stress, as determined by a significantly elevated score on measures of stress
* Receives Medicaid or participates in Medicaid HMO
* Resides in the Atlanta metropolitan area

Exclusion Criteria:

* Nonatopic, nonpsychiatric illness that requires daily medication
* Diagnosis of asthma in the year prior to study entry
* Homeless
* Caregiver is unable to complete study screening process
* Caregiver does not speak English
Evaluation of the Glycemic Index in 4 Dairy Beverages.

The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks.

Subjects will make a total of 5 visits. Four visits where they will drink a chocolate milkshake at each visit. In the other visit they will take glucose, as a comparator product.

Due to the low amount of sugars in the shakes, subjects will drink the equivalent of 25g of glucose.

At each visit subjects will have to come fasting, and samples will be collected at 9 different times.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes (10 men and 10 women).
* Subjects aged between 20 and 35 years.
* Subjects with a body mass index between 20 and 25 kg/m2.

Exclusion Criteria:

* Subjects suffering from diabetes mellitus or any chronic disease.
* Subjects with medical problems or a diagnosed psychiatric disorder.
* Subjects with alcohol abuse or excessive alcohol consumption (\>3 glasses of wine or beer/day).
* Subjects consuming any pharmacological medication that may affect memory.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Subjects whose condition does not make them eligible for the study according to the investigator's criteria.
* Pregnant or lactating women.
OCT Eccentric Fixation and Amblyopia in Children

The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.

Aim 1. OCT EF changes with patching treatment at 12 weeks visit.

Aim 2. OCT EF changes with foveation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines,
2. ocular causes of amblyopia that were identified as refractive(i.e., anisometropic, strabismus, or strabismic-anisometropic.

   * Anisometropia included interocular difference of spherical equivalent \>=1D or interocular difference of astigmatism cylinder magnitude \>=1D;
   * strabismus included those with deviation \>=10PD or good alignment after prior strabismus surgery;
   * combined type included those who meet the criteria of both anisometropia and strabismus.
   * For the patching group, we will enroll 15 children with strabismic amblyopia who are prescribed patching treatment. Age: 4-12 years old.
   * For the foveation therapy group, we will enroll 15 children with strabismic amblyopia who are prescribed foveation therapies. Age: 8-16 years old.

Exclusion Criteria:

* born before 32 weeks gestational age;
* neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;
* congenital or acquired macular pathology.